News on LASIK and Other Refractive Eye Surgery
Accelerated Corneal Crosslinking Procedure Receives CE Approval; Designed to Strengthen Eye Surface After LASIK
WALTHAM, Mass., February 2012 — A procedure called Lasik Xtra, which is designed to strengthen the cornea after LASIK, has received CE approval for marketing in the European Union. It was just approved in Canada as well.
Marketed by Avedro, Inc., Lasik Xtra is a corneal crosslinking procedure that applies the company's VibeX riboflavin ophthalmic solution to the eye's surface (cornea), and then uses Avedro's KXL System to irradiate the cornea with UV-A rays. Lasik Xtra is an accelerated form of crosslinking — Avedro says it takes two minutes — which makes it more convenient to combine with LASIK.
Avedro said that in April it will report on studies that show the procedure has helped people who received hyperopic LASIK, which tends to regress more than myopic LASIK, to maintain the vision correction they had received from LASIK.
Although corneal crosslinking has not received FDA approval yet, Avedro's VibeX solution has received orphan drug approvals from the agency. Orphan drug status is usually conferred on treatments for rare medical conditions (in this case, keratoconus, which is a gradual thinning of the cornea).
Could Monovision LASIK Cause Strabismus?
ATLANTA, June 2011 — In people with a history of strabismus, caution may be in order when considering monovision LASIK or a monovision mode of fitting contact lenses or implanting intraocular lenses.
In a recent review of the clinical records of 12 of his patients, pediatric ophthalmologist Zane F. Pollard, MD checked for a link between switching to monovision and the subsequent onset of strabismus, an eye misalignment that causes blurry vision.
Monovision is a type of vision correction in which one eye is corrected for distance vision and the other is corrected for near vision. The eyes continue to work together to focus, but one or the other eye will carry more of the load, depending on whether it's looking near or far. It is a popular option for people with presbyopia. Monovision can be induced with LASIK, contact lenses or intraocular lens implantation during cataract surgery.
Dr. Pollard and his associates wanted to know if the monovision produced new strabismus or whether the strabismus onset was related to a previously existing strabismus. The patients' near eyes were converted to distance vision, and they were asked to use reading glasses for near work. Of the 12 people, seven experienced a realignment of their eyes to normal, while five needed surgery to achieve normal alignment.
The researchers concluded that while monovision works for most people, those with a previous history of strabismus may not be suitable candidates for it, and if they do have monovision correction, the difference in refractive powers for the eyes should probably be kept small, such as 1.25 to 1.50 diopters. Dr. Pollard commented that most of his monovision surgery patients developed strabismus after two years, even though their pre-surgery monovision trial with a contact lens had suggested that they could probably tolerate monovision.
The study report appeared on the American Journal of Ophthalmology website ahead of print in June.
Kamra Corneal Inlay Shows Promise for Near Vision
IRVINE, Calif., December 2010 — Ninety-seven percent of people implanted with the Kamra corneal inlay over a three-year period achieved J3 vision or better, with a mean near vision acuity of J1, according to a presentation at the American Academy of Ophthalmology's annual meeting in late October.
J3 and J1 are measurements on the Jaeger near point eye chart, used to determine how well you can see printed letters when reading up close. The type scale ranges from J1 (smallest) to J20.
Also, 91 percent achieved intermediate visual acuity of 20/32, so they were able to not only read the newspaper, but also see computer screens and road signs, all without glasses or contact lenses.
The procedure involves making a corneal flap. The Kamra inlay is donut-shaped and is placed in the center of the cornea of the non-dominant eye; then the flap is placed over it. The inlay uses "pinhole" optics to block peripheral light but allow central light to come into the eye, which improves near vision. The Kamra inlay is removable if necessary.
AcuFocus launched the Kamra intracorneal inlay in Europe and Asia in October. It is still in testing in the United States.
Is It Safe To Have LASIK After Cataract Surgery
To Refine Your Vision?
ALICANTE, Spain, December 2010 — A retrospective study of 100 eyes showed that after cataract surgery with either monofocal or multifocal intraocular lens (IOL) implantation, LASIK was generally safe and effective in refining vision even further.
However, LASIK performed on the eyes that had received the monofocal IOLs provided a more accurate outcome than LASIK done on the eyes with multifocal IOLs.
Also, hyperopic LASIK for farsightedness provided a less predictable outcome in the multifocal IOL eyes.
The study appeared in the Journal of Refractive Surgery in August.
Renamed the Vue+, PresbyLens May Undergo
Expanded Clinical Testing Soon
LAKE FOREST, Calif., September 2010 — Enrollment and initial followup in phase 1 of the Food and Drug Administration clinical trial of the PresbyLens corneal inlay has ended. (See May news item.)
ReVision Optics, which is developing the inlay, has renamed it Vue+ and filed with the FDA to expand the trial to three years and 400 presbyopic subjects.
The Vue+ is a small, contact lens-type device that is inserted under the surface of the eye to reshape it, for improved near vision.
Femtosecond-Only Laser Vision Correction Introduced
DUBLIN, Calif., May 2010 — Carl Zeiss Meditec has released its new ReLEx vision correction method outside the United States. ReLEx uses only the VisuMax Femtosecond laser, as opposed to other LASIK methods that use a combination of a femtosecond laser or a microkeratome (blade) to create the flap and an excimer laser to correct the vision problem.
In the ReLEx version of LASIK, a flap is cut and a piece of tissue called a lenticule is created under the eye's surface. The tissue is lifted out, and the flap is replaced on the eye.
In a release, Carl Zeiss Meditec CEO Ludwin Monz commented that the system would deliver "unprecedented workflow benefits" to refractive surgery practices.
The VisuMax Femtosecond laser can be used for vision correction procedures other than LASIK, such as the FLEx (femtosecond lamellar extraction) method and the SMILE (small incision lamellar extraction) method. ReLEx allows for small flap sizes, too. As of April 10, ReLEx procedures had been performed on more than 1,000 eyes outside the U.S.
PresbyLens Clinical Trials Begin
LAKE FOREST, Calif., May 2010 — The PresbyLens corneal inlay is in U.S. clinical trials for the correction of presbyopia, the loss of near vision that comes with age.
ReVision Optics is developing the procedure and conducting the trials, which will treat 30 eyes in Greenwood Village, Colo., and Houston during the first study phase.
The PresbyLens is very thin, is made of a biocompatible material similar to that of a contact lens and is inserted in the cornea, reshaping just the center of it in order to improve near vision. The procedure takes about 20 minutes. The PresbyLens is already approved for sale in Europe.
Microwave Energy Used in Vision Correction Procedure
WALTHAM, Mass., April 2010 — A new type of vision correction surgery called Keraflex applies microwave energy in a ring-shaped pattern to the periphery of the cornea to flatten it and thereby reduce or eliminate myopia.
The energy causes collagen in the cornea to shrink, which makes it flatter, and in that respect is similar to CK, which uses radiofrequency energy to achieve the same type of collagen shrinkage.
During the microwave procedure, the surgeon controls the temperature of the cornea with a coolant, then applies the microwave energy to the cooled area. The method is designed to avoid damage to the outer layer of the cornea.
The procedure may appeal to those who have less severe myopia than those who normally choose LASIK and who may have fears about undergoing LASIK. The microwave energy procedure involves no cutting of eye tissue and does not permanently alter the cornea.
According to Avedro, Inc., the company that is developing the Keraflex procedure and the Vedera KXS machine that delivers the microwave energy, the procedure is in clinical testing in Europe and is planned for testing in the United States this year
New Technology Adds Precision to Lasik Surgery
Laser surgery revolutionized eyesight correction when it was introduced ten years ago. Originally, the procedure was used only to correct nearsightedness. Now, Lasik is used to correct most vision problems, including farsightedness and astigmatism. That's enticing more and more people to choose to have their corneas reshaped and their vision corrected. Every year, more than four million Americans make this choice.
Recently, Los Angeles resident Chet Lee, 30, had surgery at the UCLA Jules Stein Eye Institute, where he was able to take advantage of two of the newest techniques in Lasik: Wavefront-guided Lasik and all-laser Lasik.
Wavefront-guided Lasik, or "custom Lasik," uses a computer to diagnose and customize correction of the eye.
All-laser Lasik uses a laser rather than a blade to trim off the top of the cornea. Right now, that laser is only sold by the company IntraLase Corp. Surgeons think the new bladeless Lasik is more precise, easier to use, and reduces complications.
Dr. D. Rex Hamilton, Director of the UCLA Laser Refractive Center at the Jules Stein Eye Institute, says the new custom Lasik procedure helps make Lasik more exact. A camera takes pictures of how the eye actually reflects and filters light. The more dramatic the angles, the more Lasik correction is needed.
The new Wavefront-guided technology is more eye specific, Hamilton says.
"Everybody has optics of their eye that is unique. No two eyes are the same," Hamilton explains. "We can now measure those optics in a very detailed way and then use the laser to reshape the cornea for that particular optical fingerprint. It's like a detailed map of the optics."
With this detailed map, Hamilton says, the computer then figures out exactly how surgeons need to reshape the cornea to remove optical imperfections and correct vision.
For the patient, Hamilton says, "this translates into better nighttime vision, better quality, less halos, less glare of lights."
Before custom Lasik, decisions about how to reshape the eye were more subjective because doctors relied on a patient's prescription for glasses. And prescriptions are based on a patient's assessment of their own vision as they read the eye charts in doctor's offices.
With custom Lasik, decisions are more scientific, says Hamilton, because a computer measures how light is reflected in the eye. The pattern it produces tells doctors exactly how vision is impaired, and how to fix it.
"The computer figures out what I need to do to reshape the cornea to remove optical imperfections," Hamilton says.
Chet was nervous, but excited about the procedure's potential. He was hoping for 20/20 vision in both eyes, and eager to be done with contacts, which, at various times, had broken inside his eye, cut his cornea, fallen out of his eye or gotten lost.
The new "all-laser" Lasik was what finally brought Chet to UCLA. He'd been thinking about Lasik for about nine years but was squeamish about the surgery. During Lasik, surgeons cut a thin flap in the cornea and then use a laser to reshape the cornea underneath. Most surgeons use a blade, which automatically moves across the cornea to make the flap. But at UCLA, they've gotten rid of the blade and now use a laser to create the flap.
The laser more or less separates tissue, says Hamilton, "creating little bubbles of space that are right next to each other on a microscopic level that creates a plane that I can then lift with a blunt instrument."
In Chet Lee's surgery, it took only a few minutes for the laser to move across the cornea and separate the tissue to create a flap. Then Hamilton can work from a smooth, flat surface in order to create the new 'customized reshaped cornea." Lee is very nearsighted, so it takes a full two minutes on each eye for the laser to do its work.
At the end of surgery, Chet seems relieved. It wasn't as bad as expected, he says. On a follow-up visit the next day, his vision tests at nearly perfect: 20/20 in one eye, 20/25 in the other.
"Typical," says Dr. Hamilton.
Hamilton says that complications from Lasik are rare but include distortions, such as glare or halos, especially at night. The risk of that happening is greatly decreased, he says, because of the earlier computer measurements he took of the eye.
Although the computer measurements don't add a lot to the cost of Lasik, the new 'all-laser' procedure does. Conventional Lasik averages around $1,500 per eye. All-laser Lasik is more.
In Chet Lee's case, the cost was $3,050 per eye — a total of $6,100. And for the most part, Lasik surgery is not covered by insurance.
Experts Advise New Warnings for LASIK
April 25, 2008 -- The FDA should do more to warn patients about the risks of popular laser vision corrective surgery, an expert panel has concluded.
The recommendations came after more than a dozen LASIK patients or their family members testified Friday about severe reactions to the surgery. Most said their doctors did not adequately warn them that vision loss or eye dryness could persist, in some cases, for years.
"For a small minority, their regret is profound," said Todd Krouner, a New York attorney who represents about half a dozen LASIK patients, including the wife of a former police officer who Krouner said blamed a botched LASIK surgery for his suicide.
"It is not about the 20 minutes in surgery, it's about what came before it and what has come after it. It's about a lack of solution for them," said Rebecca Petris, a former LASIK patient who now runs a network of dissatisfied patients.
The FDA has launched a new national study of patient outcomes, along with the National Eye Institute and the American Society of Cataract and Refractive Surgery (ASCRS) to try to compile more information on the rate of poor LASIK results.
The study is likely to take years to complete. In the meantime, experts said information given to patients considering LASIK surgery should warn more clearly of the possibility of long-term vision disruptions, including "halos," "starbursts," blurriness, and multiple vision.
The FDA has become increasingly concerned about reports of severe complications but has acknowledged that it does not have enough studies to know how often severe reactions occur. Those reports, which include debilitating eye dryness, blurred vision, and other vision disruptions, could suggest doctors are not doing enough to inform patients about the potential risks, the agency said.
Debate Over LASIK
LASIK (which stands for laser-assisted in situ keratomileusis) is performed in more than 700,000 U.S. patients each year. One study published last month by a trade group representing LASIK surgeons suggested about 95% of all patients are satisfied with their procedure.
"Even with the stats we have, we have info that the vast majority of patients who have LASIK do very well," said Jayne S. Weiss, MD, who chaired the advisory panel.
News on LASIK and Other Refractive Eye Surgery
Accelerated Corneal Crosslinking Procedure Receives CE Approval; Designed to Strengthen Eye Surface After LASIK
WALTHAM, Mass., February 2012 — A procedure called Lasik Xtra, which is designed to strengthen the cornea after LASIK, has received CE approval for marketing in the European Union. It was just approved in Canada as well.
Marketed by Avedro, Inc., Lasik Xtra is a corneal crosslinking procedure that applies the company's VibeX riboflavin ophthalmic solution to the eye's surface (cornea), and then uses Avedro's KXL System to irradiate the cornea with UV-A rays. Lasik Xtra is an accelerated form of crosslinking — Avedro says it takes two minutes — which makes it more convenient to combine with LASIK.
Avedro said that in April it will report on studies that show the procedure has helped people who received hyperopic LASIK, which tends to regress more than myopic LASIK, to maintain the vision correction they had received from LASIK.
Although corneal crosslinking has not received FDA approval yet, Avedro's VibeX solution has received orphan drug approvals from the agency. Orphan drug status is usually conferred on treatments for rare medical conditions (in this case, keratoconus, which is a gradual thinning of the cornea).
Could Monovision LASIK Cause Strabismus?
ATLANTA, June 2011 — In people with a history of strabismus, caution may be in order when considering monovision LASIK or a monovision mode of fitting contact lenses or implanting intraocular lenses.
In a recent review of the clinical records of 12 of his patients, pediatric ophthalmologist Zane F. Pollard, MD checked for a link between switching to monovision and the subsequent onset of strabismus, an eye misalignment that causes blurry vision.
Monovision is a type of vision correction in which one eye is corrected for distance vision and the other is corrected for near vision. The eyes continue to work together to focus, but one or the other eye will carry more of the load, depending on whether it's looking near or far. It is a popular option for people with presbyopia. Monovision can be induced with LASIK, contact lenses or intraocular lens implantation during cataract surgery.
Dr. Pollard and his associates wanted to know if the monovision produced new strabismus or whether the strabismus onset was related to a previously existing strabismus. The patients' near eyes were converted to distance vision, and they were asked to use reading glasses for near work. Of the 12 people, seven experienced a realignment of their eyes to normal, while five needed surgery to achieve normal alignment.
The researchers concluded that while monovision works for most people, those with a previous history of strabismus may not be suitable candidates for it, and if they do have monovision correction, the difference in refractive powers for the eyes should probably be kept small, such as 1.25 to 1.50 diopters. Dr. Pollard commented that most of his monovision surgery patients developed strabismus after two years, even though their pre-surgery monovision trial with a contact lens had suggested that they could probably tolerate monovision.
The study report appeared on the American Journal of Ophthalmology website ahead of print in June.
Kamra Corneal Inlay Shows Promise for Near Vision
IRVINE, Calif., December 2010 — Ninety-seven percent of people implanted with the Kamra corneal inlay over a three-year period achieved J3 vision or better, with a mean near vision acuity of J1, according to a presentation at the American Academy of Ophthalmology's annual meeting in late October.
J3 and J1 are measurements on the Jaeger near point eye chart, used to determine how well you can see printed letters when reading up close. The type scale ranges from J1 (smallest) to J20.
Also, 91 percent achieved intermediate visual acuity of 20/32, so they were able to not only read the newspaper, but also see computer screens and road signs, all without glasses or contact lenses.
The procedure involves making a corneal flap. The Kamra inlay is donut-shaped and is placed in the center of the cornea of the non-dominant eye; then the flap is placed over it. The inlay uses "pinhole" optics to block peripheral light but allow central light to come into the eye, which improves near vision. The Kamra inlay is removable if necessary.
AcuFocus launched the Kamra intracorneal inlay in Europe and Asia in October. It is still in testing in the United States.
Is It Safe To Have LASIK After Cataract Surgery
To Refine Your Vision?
ALICANTE, Spain, December 2010 — A retrospective study of 100 eyes showed that after cataract surgery with either monofocal or multifocal intraocular lens (IOL) implantation, LASIK was generally safe and effective in refining vision even further.
However, LASIK performed on the eyes that had received the monofocal IOLs provided a more accurate outcome than LASIK done on the eyes with multifocal IOLs.
Also, hyperopic LASIK for farsightedness provided a less predictable outcome in the multifocal IOL eyes.
The study appeared in the Journal of Refractive Surgery in August.
Renamed the Vue+, PresbyLens May Undergo
Expanded Clinical Testing Soon
LAKE FOREST, Calif., September 2010 — Enrollment and initial followup in phase 1 of the Food and Drug Administration clinical trial of the PresbyLens corneal inlay has ended. (See May news item.)
ReVision Optics, which is developing the inlay, has renamed it Vue+ and filed with the FDA to expand the trial to three years and 400 presbyopic subjects.
The Vue+ is a small, contact lens-type device that is inserted under the surface of the eye to reshape it, for improved near vision.
Femtosecond-Only Laser Vision Correction Introduced
DUBLIN, Calif., May 2010 — Carl Zeiss Meditec has released its new ReLEx vision correction method outside the United States. ReLEx uses only the VisuMax Femtosecond laser, as opposed to other LASIK methods that use a combination of a femtosecond laser or a microkeratome (blade) to create the flap and an excimer laser to correct the vision problem.
In the ReLEx version of LASIK, a flap is cut and a piece of tissue called a lenticule is created under the eye's surface. The tissue is lifted out, and the flap is replaced on the eye.
In a release, Carl Zeiss Meditec CEO Ludwin Monz commented that the system would deliver "unprecedented workflow benefits" to refractive surgery practices.
The VisuMax Femtosecond laser can be used for vision correction procedures other than LASIK, such as the FLEx (femtosecond lamellar extraction) method and the SMILE (small incision lamellar extraction) method. ReLEx allows for small flap sizes, too. As of April 10, ReLEx procedures had been performed on more than 1,000 eyes outside the U.S.
PresbyLens Clinical Trials Begin
LAKE FOREST, Calif., May 2010 — The PresbyLens corneal inlay is in U.S. clinical trials for the correction of presbyopia, the loss of near vision that comes with age.
ReVision Optics is developing the procedure and conducting the trials, which will treat 30 eyes in Greenwood Village, Colo., and Houston during the first study phase.
The PresbyLens is very thin, is made of a biocompatible material similar to that of a contact lens and is inserted in the cornea, reshaping just the center of it in order to improve near vision. The procedure takes about 20 minutes. The PresbyLens is already approved for sale in Europe.
Microwave Energy Used in Vision Correction Procedure
WALTHAM, Mass., April 2010 — A new type of vision correction surgery called Keraflex applies microwave energy in a ring-shaped pattern to the periphery of the cornea to flatten it and thereby reduce or eliminate myopia.
The energy causes collagen in the cornea to shrink, which makes it flatter, and in that respect is similar to CK, which uses radiofrequency energy to achieve the same type of collagen shrinkage.
During the microwave procedure, the surgeon controls the temperature of the cornea with a coolant, then applies the microwave energy to the cooled area. The method is designed to avoid damage to the outer layer of the cornea.
The procedure may appeal to those who have less severe myopia than those who normally choose LASIK and who may have fears about undergoing LASIK. The microwave energy procedure involves no cutting of eye tissue and does not permanently alter the cornea.
According to Avedro, Inc., the company that is developing the Keraflex procedure and the Vedera KXS machine that delivers the microwave energy, the procedure is in clinical testing in Europe and is planned for testing in the United States this year
"It is really a referendum on the performance of LASIK by some surgeons who should really be doing a better job," said Weiss, a professor of ophthalmology at Wayne State University in Detroit.
Experts also recommended that both patient information and FDA's LASIK web site contain photos of potential vision problems.
"We do want something that people will read and see if they have the opportunity to," Weiss said.
Experts also urged the agency to include more warnings about the potential risks of LASIK in women using hormone replacement therapy since the drugs can alter the cornea. And they called for more warnings for doctors who evaluate which patients may not be candidates for the procedure.
Accelerated Corneal Crosslinking Procedure Receives CE Approval; Designed to Strengthen Eye Surface After LASIK
WALTHAM, Mass., February 2012 — A procedure called Lasik Xtra, which is designed to strengthen the cornea after LASIK, has received CE approval for marketing in the European Union. It was just approved in Canada as well.
Marketed by Avedro, Inc., Lasik Xtra is a corneal crosslinking procedure that applies the company's VibeX riboflavin ophthalmic solution to the eye's surface (cornea), and then uses Avedro's KXL System to irradiate the cornea with UV-A rays. Lasik Xtra is an accelerated form of crosslinking — Avedro says it takes two minutes — which makes it more convenient to combine with LASIK.
Avedro said that in April it will report on studies that show the procedure has helped people who received hyperopic LASIK, which tends to regress more than myopic LASIK, to maintain the vision correction they had received from LASIK.
Although corneal crosslinking has not received FDA approval yet, Avedro's VibeX solution has received orphan drug approvals from the agency. Orphan drug status is usually conferred on treatments for rare medical conditions (in this case, keratoconus, which is a gradual thinning of the cornea).
Could Monovision LASIK Cause Strabismus?
ATLANTA, June 2011 — In people with a history of strabismus, caution may be in order when considering monovision LASIK or a monovision mode of fitting contact lenses or implanting intraocular lenses.
In a recent review of the clinical records of 12 of his patients, pediatric ophthalmologist Zane F. Pollard, MD checked for a link between switching to monovision and the subsequent onset of strabismus, an eye misalignment that causes blurry vision.
Monovision is a type of vision correction in which one eye is corrected for distance vision and the other is corrected for near vision. The eyes continue to work together to focus, but one or the other eye will carry more of the load, depending on whether it's looking near or far. It is a popular option for people with presbyopia. Monovision can be induced with LASIK, contact lenses or intraocular lens implantation during cataract surgery.
Dr. Pollard and his associates wanted to know if the monovision produced new strabismus or whether the strabismus onset was related to a previously existing strabismus. The patients' near eyes were converted to distance vision, and they were asked to use reading glasses for near work. Of the 12 people, seven experienced a realignment of their eyes to normal, while five needed surgery to achieve normal alignment.
The researchers concluded that while monovision works for most people, those with a previous history of strabismus may not be suitable candidates for it, and if they do have monovision correction, the difference in refractive powers for the eyes should probably be kept small, such as 1.25 to 1.50 diopters. Dr. Pollard commented that most of his monovision surgery patients developed strabismus after two years, even though their pre-surgery monovision trial with a contact lens had suggested that they could probably tolerate monovision.
The study report appeared on the American Journal of Ophthalmology website ahead of print in June.
Kamra Corneal Inlay Shows Promise for Near Vision
IRVINE, Calif., December 2010 — Ninety-seven percent of people implanted with the Kamra corneal inlay over a three-year period achieved J3 vision or better, with a mean near vision acuity of J1, according to a presentation at the American Academy of Ophthalmology's annual meeting in late October.
J3 and J1 are measurements on the Jaeger near point eye chart, used to determine how well you can see printed letters when reading up close. The type scale ranges from J1 (smallest) to J20.
Also, 91 percent achieved intermediate visual acuity of 20/32, so they were able to not only read the newspaper, but also see computer screens and road signs, all without glasses or contact lenses.
The procedure involves making a corneal flap. The Kamra inlay is donut-shaped and is placed in the center of the cornea of the non-dominant eye; then the flap is placed over it. The inlay uses "pinhole" optics to block peripheral light but allow central light to come into the eye, which improves near vision. The Kamra inlay is removable if necessary.
AcuFocus launched the Kamra intracorneal inlay in Europe and Asia in October. It is still in testing in the United States.
Is It Safe To Have LASIK After Cataract Surgery
To Refine Your Vision?
ALICANTE, Spain, December 2010 — A retrospective study of 100 eyes showed that after cataract surgery with either monofocal or multifocal intraocular lens (IOL) implantation, LASIK was generally safe and effective in refining vision even further.
However, LASIK performed on the eyes that had received the monofocal IOLs provided a more accurate outcome than LASIK done on the eyes with multifocal IOLs.
Also, hyperopic LASIK for farsightedness provided a less predictable outcome in the multifocal IOL eyes.
The study appeared in the Journal of Refractive Surgery in August.
Renamed the Vue+, PresbyLens May Undergo
Expanded Clinical Testing Soon
LAKE FOREST, Calif., September 2010 — Enrollment and initial followup in phase 1 of the Food and Drug Administration clinical trial of the PresbyLens corneal inlay has ended. (See May news item.)
ReVision Optics, which is developing the inlay, has renamed it Vue+ and filed with the FDA to expand the trial to three years and 400 presbyopic subjects.
The Vue+ is a small, contact lens-type device that is inserted under the surface of the eye to reshape it, for improved near vision.
Femtosecond-Only Laser Vision Correction Introduced
DUBLIN, Calif., May 2010 — Carl Zeiss Meditec has released its new ReLEx vision correction method outside the United States. ReLEx uses only the VisuMax Femtosecond laser, as opposed to other LASIK methods that use a combination of a femtosecond laser or a microkeratome (blade) to create the flap and an excimer laser to correct the vision problem.
In the ReLEx version of LASIK, a flap is cut and a piece of tissue called a lenticule is created under the eye's surface. The tissue is lifted out, and the flap is replaced on the eye.
In a release, Carl Zeiss Meditec CEO Ludwin Monz commented that the system would deliver "unprecedented workflow benefits" to refractive surgery practices.
The VisuMax Femtosecond laser can be used for vision correction procedures other than LASIK, such as the FLEx (femtosecond lamellar extraction) method and the SMILE (small incision lamellar extraction) method. ReLEx allows for small flap sizes, too. As of April 10, ReLEx procedures had been performed on more than 1,000 eyes outside the U.S.
PresbyLens Clinical Trials Begin
LAKE FOREST, Calif., May 2010 — The PresbyLens corneal inlay is in U.S. clinical trials for the correction of presbyopia, the loss of near vision that comes with age.
ReVision Optics is developing the procedure and conducting the trials, which will treat 30 eyes in Greenwood Village, Colo., and Houston during the first study phase.
The PresbyLens is very thin, is made of a biocompatible material similar to that of a contact lens and is inserted in the cornea, reshaping just the center of it in order to improve near vision. The procedure takes about 20 minutes. The PresbyLens is already approved for sale in Europe.
Microwave Energy Used in Vision Correction Procedure
WALTHAM, Mass., April 2010 — A new type of vision correction surgery called Keraflex applies microwave energy in a ring-shaped pattern to the periphery of the cornea to flatten it and thereby reduce or eliminate myopia.
The energy causes collagen in the cornea to shrink, which makes it flatter, and in that respect is similar to CK, which uses radiofrequency energy to achieve the same type of collagen shrinkage.
During the microwave procedure, the surgeon controls the temperature of the cornea with a coolant, then applies the microwave energy to the cooled area. The method is designed to avoid damage to the outer layer of the cornea.
The procedure may appeal to those who have less severe myopia than those who normally choose LASIK and who may have fears about undergoing LASIK. The microwave energy procedure involves no cutting of eye tissue and does not permanently alter the cornea.
According to Avedro, Inc., the company that is developing the Keraflex procedure and the Vedera KXS machine that delivers the microwave energy, the procedure is in clinical testing in Europe and is planned for testing in the United States this year
New Technology Adds Precision to Lasik Surgery
Laser surgery revolutionized eyesight correction when it was introduced ten years ago. Originally, the procedure was used only to correct nearsightedness. Now, Lasik is used to correct most vision problems, including farsightedness and astigmatism. That's enticing more and more people to choose to have their corneas reshaped and their vision corrected. Every year, more than four million Americans make this choice.
Recently, Los Angeles resident Chet Lee, 30, had surgery at the UCLA Jules Stein Eye Institute, where he was able to take advantage of two of the newest techniques in Lasik: Wavefront-guided Lasik and all-laser Lasik.
Wavefront-guided Lasik, or "custom Lasik," uses a computer to diagnose and customize correction of the eye.
All-laser Lasik uses a laser rather than a blade to trim off the top of the cornea. Right now, that laser is only sold by the company IntraLase Corp. Surgeons think the new bladeless Lasik is more precise, easier to use, and reduces complications.
Dr. D. Rex Hamilton, Director of the UCLA Laser Refractive Center at the Jules Stein Eye Institute, says the new custom Lasik procedure helps make Lasik more exact. A camera takes pictures of how the eye actually reflects and filters light. The more dramatic the angles, the more Lasik correction is needed.
The new Wavefront-guided technology is more eye specific, Hamilton says.
"Everybody has optics of their eye that is unique. No two eyes are the same," Hamilton explains. "We can now measure those optics in a very detailed way and then use the laser to reshape the cornea for that particular optical fingerprint. It's like a detailed map of the optics."
With this detailed map, Hamilton says, the computer then figures out exactly how surgeons need to reshape the cornea to remove optical imperfections and correct vision.
For the patient, Hamilton says, "this translates into better nighttime vision, better quality, less halos, less glare of lights."
Before custom Lasik, decisions about how to reshape the eye were more subjective because doctors relied on a patient's prescription for glasses. And prescriptions are based on a patient's assessment of their own vision as they read the eye charts in doctor's offices.
With custom Lasik, decisions are more scientific, says Hamilton, because a computer measures how light is reflected in the eye. The pattern it produces tells doctors exactly how vision is impaired, and how to fix it.
"The computer figures out what I need to do to reshape the cornea to remove optical imperfections," Hamilton says.
Chet was nervous, but excited about the procedure's potential. He was hoping for 20/20 vision in both eyes, and eager to be done with contacts, which, at various times, had broken inside his eye, cut his cornea, fallen out of his eye or gotten lost.
The new "all-laser" Lasik was what finally brought Chet to UCLA. He'd been thinking about Lasik for about nine years but was squeamish about the surgery. During Lasik, surgeons cut a thin flap in the cornea and then use a laser to reshape the cornea underneath. Most surgeons use a blade, which automatically moves across the cornea to make the flap. But at UCLA, they've gotten rid of the blade and now use a laser to create the flap.
The laser more or less separates tissue, says Hamilton, "creating little bubbles of space that are right next to each other on a microscopic level that creates a plane that I can then lift with a blunt instrument."
In Chet Lee's surgery, it took only a few minutes for the laser to move across the cornea and separate the tissue to create a flap. Then Hamilton can work from a smooth, flat surface in order to create the new 'customized reshaped cornea." Lee is very nearsighted, so it takes a full two minutes on each eye for the laser to do its work.
At the end of surgery, Chet seems relieved. It wasn't as bad as expected, he says. On a follow-up visit the next day, his vision tests at nearly perfect: 20/20 in one eye, 20/25 in the other.
"Typical," says Dr. Hamilton.
Hamilton says that complications from Lasik are rare but include distortions, such as glare or halos, especially at night. The risk of that happening is greatly decreased, he says, because of the earlier computer measurements he took of the eye.
Although the computer measurements don't add a lot to the cost of Lasik, the new 'all-laser' procedure does. Conventional Lasik averages around $1,500 per eye. All-laser Lasik is more.
In Chet Lee's case, the cost was $3,050 per eye — a total of $6,100. And for the most part, Lasik surgery is not covered by insurance.
Experts Advise New Warnings for LASIK
April 25, 2008 -- The FDA should do more to warn patients about the risks of popular laser vision corrective surgery, an expert panel has concluded.
The recommendations came after more than a dozen LASIK patients or their family members testified Friday about severe reactions to the surgery. Most said their doctors did not adequately warn them that vision loss or eye dryness could persist, in some cases, for years.
"For a small minority, their regret is profound," said Todd Krouner, a New York attorney who represents about half a dozen LASIK patients, including the wife of a former police officer who Krouner said blamed a botched LASIK surgery for his suicide.
"It is not about the 20 minutes in surgery, it's about what came before it and what has come after it. It's about a lack of solution for them," said Rebecca Petris, a former LASIK patient who now runs a network of dissatisfied patients.
The FDA has launched a new national study of patient outcomes, along with the National Eye Institute and the American Society of Cataract and Refractive Surgery (ASCRS) to try to compile more information on the rate of poor LASIK results.
The study is likely to take years to complete. In the meantime, experts said information given to patients considering LASIK surgery should warn more clearly of the possibility of long-term vision disruptions, including "halos," "starbursts," blurriness, and multiple vision.
The FDA has become increasingly concerned about reports of severe complications but has acknowledged that it does not have enough studies to know how often severe reactions occur. Those reports, which include debilitating eye dryness, blurred vision, and other vision disruptions, could suggest doctors are not doing enough to inform patients about the potential risks, the agency said.
Debate Over LASIK
LASIK (which stands for laser-assisted in situ keratomileusis) is performed in more than 700,000 U.S. patients each year. One study published last month by a trade group representing LASIK surgeons suggested about 95% of all patients are satisfied with their procedure.
"Even with the stats we have, we have info that the vast majority of patients who have LASIK do very well," said Jayne S. Weiss, MD, who chaired the advisory panel.
News on LASIK and Other Refractive Eye Surgery
Accelerated Corneal Crosslinking Procedure Receives CE Approval; Designed to Strengthen Eye Surface After LASIK
WALTHAM, Mass., February 2012 — A procedure called Lasik Xtra, which is designed to strengthen the cornea after LASIK, has received CE approval for marketing in the European Union. It was just approved in Canada as well.
Marketed by Avedro, Inc., Lasik Xtra is a corneal crosslinking procedure that applies the company's VibeX riboflavin ophthalmic solution to the eye's surface (cornea), and then uses Avedro's KXL System to irradiate the cornea with UV-A rays. Lasik Xtra is an accelerated form of crosslinking — Avedro says it takes two minutes — which makes it more convenient to combine with LASIK.
Avedro said that in April it will report on studies that show the procedure has helped people who received hyperopic LASIK, which tends to regress more than myopic LASIK, to maintain the vision correction they had received from LASIK.
Although corneal crosslinking has not received FDA approval yet, Avedro's VibeX solution has received orphan drug approvals from the agency. Orphan drug status is usually conferred on treatments for rare medical conditions (in this case, keratoconus, which is a gradual thinning of the cornea).
Could Monovision LASIK Cause Strabismus?
ATLANTA, June 2011 — In people with a history of strabismus, caution may be in order when considering monovision LASIK or a monovision mode of fitting contact lenses or implanting intraocular lenses.
In a recent review of the clinical records of 12 of his patients, pediatric ophthalmologist Zane F. Pollard, MD checked for a link between switching to monovision and the subsequent onset of strabismus, an eye misalignment that causes blurry vision.
Monovision is a type of vision correction in which one eye is corrected for distance vision and the other is corrected for near vision. The eyes continue to work together to focus, but one or the other eye will carry more of the load, depending on whether it's looking near or far. It is a popular option for people with presbyopia. Monovision can be induced with LASIK, contact lenses or intraocular lens implantation during cataract surgery.
Dr. Pollard and his associates wanted to know if the monovision produced new strabismus or whether the strabismus onset was related to a previously existing strabismus. The patients' near eyes were converted to distance vision, and they were asked to use reading glasses for near work. Of the 12 people, seven experienced a realignment of their eyes to normal, while five needed surgery to achieve normal alignment.
The researchers concluded that while monovision works for most people, those with a previous history of strabismus may not be suitable candidates for it, and if they do have monovision correction, the difference in refractive powers for the eyes should probably be kept small, such as 1.25 to 1.50 diopters. Dr. Pollard commented that most of his monovision surgery patients developed strabismus after two years, even though their pre-surgery monovision trial with a contact lens had suggested that they could probably tolerate monovision.
The study report appeared on the American Journal of Ophthalmology website ahead of print in June.
Kamra Corneal Inlay Shows Promise for Near Vision
IRVINE, Calif., December 2010 — Ninety-seven percent of people implanted with the Kamra corneal inlay over a three-year period achieved J3 vision or better, with a mean near vision acuity of J1, according to a presentation at the American Academy of Ophthalmology's annual meeting in late October.
J3 and J1 are measurements on the Jaeger near point eye chart, used to determine how well you can see printed letters when reading up close. The type scale ranges from J1 (smallest) to J20.
Also, 91 percent achieved intermediate visual acuity of 20/32, so they were able to not only read the newspaper, but also see computer screens and road signs, all without glasses or contact lenses.
The procedure involves making a corneal flap. The Kamra inlay is donut-shaped and is placed in the center of the cornea of the non-dominant eye; then the flap is placed over it. The inlay uses "pinhole" optics to block peripheral light but allow central light to come into the eye, which improves near vision. The Kamra inlay is removable if necessary.
AcuFocus launched the Kamra intracorneal inlay in Europe and Asia in October. It is still in testing in the United States.
Is It Safe To Have LASIK After Cataract Surgery
To Refine Your Vision?
ALICANTE, Spain, December 2010 — A retrospective study of 100 eyes showed that after cataract surgery with either monofocal or multifocal intraocular lens (IOL) implantation, LASIK was generally safe and effective in refining vision even further.
However, LASIK performed on the eyes that had received the monofocal IOLs provided a more accurate outcome than LASIK done on the eyes with multifocal IOLs.
Also, hyperopic LASIK for farsightedness provided a less predictable outcome in the multifocal IOL eyes.
The study appeared in the Journal of Refractive Surgery in August.
Renamed the Vue+, PresbyLens May Undergo
Expanded Clinical Testing Soon
LAKE FOREST, Calif., September 2010 — Enrollment and initial followup in phase 1 of the Food and Drug Administration clinical trial of the PresbyLens corneal inlay has ended. (See May news item.)
ReVision Optics, which is developing the inlay, has renamed it Vue+ and filed with the FDA to expand the trial to three years and 400 presbyopic subjects.
The Vue+ is a small, contact lens-type device that is inserted under the surface of the eye to reshape it, for improved near vision.
Femtosecond-Only Laser Vision Correction Introduced
DUBLIN, Calif., May 2010 — Carl Zeiss Meditec has released its new ReLEx vision correction method outside the United States. ReLEx uses only the VisuMax Femtosecond laser, as opposed to other LASIK methods that use a combination of a femtosecond laser or a microkeratome (blade) to create the flap and an excimer laser to correct the vision problem.
In the ReLEx version of LASIK, a flap is cut and a piece of tissue called a lenticule is created under the eye's surface. The tissue is lifted out, and the flap is replaced on the eye.
In a release, Carl Zeiss Meditec CEO Ludwin Monz commented that the system would deliver "unprecedented workflow benefits" to refractive surgery practices.
The VisuMax Femtosecond laser can be used for vision correction procedures other than LASIK, such as the FLEx (femtosecond lamellar extraction) method and the SMILE (small incision lamellar extraction) method. ReLEx allows for small flap sizes, too. As of April 10, ReLEx procedures had been performed on more than 1,000 eyes outside the U.S.
PresbyLens Clinical Trials Begin
LAKE FOREST, Calif., May 2010 — The PresbyLens corneal inlay is in U.S. clinical trials for the correction of presbyopia, the loss of near vision that comes with age.
ReVision Optics is developing the procedure and conducting the trials, which will treat 30 eyes in Greenwood Village, Colo., and Houston during the first study phase.
The PresbyLens is very thin, is made of a biocompatible material similar to that of a contact lens and is inserted in the cornea, reshaping just the center of it in order to improve near vision. The procedure takes about 20 minutes. The PresbyLens is already approved for sale in Europe.
Microwave Energy Used in Vision Correction Procedure
WALTHAM, Mass., April 2010 — A new type of vision correction surgery called Keraflex applies microwave energy in a ring-shaped pattern to the periphery of the cornea to flatten it and thereby reduce or eliminate myopia.
The energy causes collagen in the cornea to shrink, which makes it flatter, and in that respect is similar to CK, which uses radiofrequency energy to achieve the same type of collagen shrinkage.
During the microwave procedure, the surgeon controls the temperature of the cornea with a coolant, then applies the microwave energy to the cooled area. The method is designed to avoid damage to the outer layer of the cornea.
The procedure may appeal to those who have less severe myopia than those who normally choose LASIK and who may have fears about undergoing LASIK. The microwave energy procedure involves no cutting of eye tissue and does not permanently alter the cornea.
According to Avedro, Inc., the company that is developing the Keraflex procedure and the Vedera KXS machine that delivers the microwave energy, the procedure is in clinical testing in Europe and is planned for testing in the United States this year
"It is really a referendum on the performance of LASIK by some surgeons who should really be doing a better job," said Weiss, a professor of ophthalmology at Wayne State University in Detroit.
Experts also recommended that both patient information and FDA's LASIK web site contain photos of potential vision problems.
"We do want something that people will read and see if they have the opportunity to," Weiss said.
Experts also urged the agency to include more warnings about the potential risks of LASIK in women using hormone replacement therapy since the drugs can alter the cornea. And they called for more warnings for doctors who evaluate which patients may not be candidates for the procedure.