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News
Post-LASIK Quality of Life Study Reported Patients' Satisfaction High
An analysis of the global peer-reviewed literature found that more than 95% of patients were satisfied with the outcome of their LASIK surgery.1 The retrospective literature review was done in preparation for the prospective study to be conducted by the FDA, the ASCRS, the AAO, and the National Eye Institute. Both the completed retrospective study and the future prospective study are a part of the Joint LASIK Study Task Force's mission to provide insight into the incidence of patients' dissatisfaction with modern LASIK, the causes of their dissatisfaction, and possible treatments.
The literature review included all articles published on LASIK in peer-reviewed journals from 1988 through 2008. At the outset, investigators identified 2,915 LASIK-related abstracts. Following multistage, systematic elimination, they selected 309 articles that represented peer-reviewed, well-designed, properly conducted, randomized clinical trials or case-controlled and cohort studies. Nineteen of these articles reported on patients' satisfaction. Published from 1996 through 2007, the articles represent surgeries performed from 1995 to 2003 on 2,198 patients. Follow-up lasted from 1 month to 5 years in these studies. Patients' ages reportedly ranged from 18 to 67 years. The spherical equivalent treated ranged from -22.75 to +7.00 D.
Overall, patients' rate of satisfaction after primary LASIK surgery was 95.4% (2,097 of 2,198 patients; range of satisfaction, 87.2% to 100%). The rate was 95.3% (1,811 of 1,901 patients) after myopic LASIK and 96.3% (286 of 297 patients) after hyperopic LASIK. The overall rate of dissatisfaction was 4.6% (101 of 2,198 patients; range of dissatisfaction, 0% to 12.8%).
"Although LASIK generates the highest level of patient satisfaction of any elective surgical procedure, there still remains 4% to 5% of patients who are dissatisfied with their outcomes," Richard L. Lindstrom, MD, said in an e-mail to Cataract & Refractive Surgery Today. "According to this extensive global review of the literature, the primary reasons for patient dissatisfaction following LASIK are residual refractive error, dry eye, and night vision symptoms." Dr. Lindstrom is a founder and attending surgeon at Minnesota Eye Consultants, PA, in Bloomington, Minnesota. He is also a co-chair of the Joint LASIK Study Task Force and a co-author of the literature review.
"In most cases, residual refractive error can be treated with a laser enhancement," Dr. Lindstrom explained. "According to this study, dry eye following LASIK rarely leads to patient dissatisfaction. I find post-LASIK dry eye difficult to predict preoperatively. Fortunately, it can usually be mitigated with medical therapy, and should be treated aggressively. Newer studies suggest that wavefront-driven custom treatment and expanded optical zones can reduce night vision symptoms, but some patients complain of these symptoms, and no preoperative test including pupil size measurement is predictive of this complaint. It is appropriate that these primary causes of reduced post-LASIK satisfaction are disclosed [to] patients preoperatively."
Low-Tech, Inexpensive Procedure Saves Sight in Developing Countries
David F. Chang, MD, the 2009 Binkhorst Lecturer at the ASCRS Symposium on Cataract, IOL and Refractive Surgery in San Francisco, presented the audience with three hospital models that have successfully treated a high volume of cataract patients in a cost-effective manner. The title of Dr. Chang's lecture was, "The Greatest Challenge to Cataract Surgery. Needed: 5-Minute, $15 Cure for Blindness."
"In the developed world, who, other than ophthalmologists, can better appreciate just how daunting the challenge of reducing global blindness is?" Dr. Chang asked. "In developing countries, the obstacles include the high cost of phaco and foldable IOL technology, a critical shortage of ophthalmologists, and insufficient educational infrastructure to train novice phaco surgeons, let alone those skilled enough to tackle the advanced cataracts typically encountered."
Three programs—the Aravind Eye Care System in southern India, the Tilganga Eye Centre in Kathmandu, Nepal, and Project Vision in China—have overcome these obstacles by offering fast, low-tech, high-volume cataract surgery in ways that maximize the resources available in their areas. At Aravind, a single surgeon performs 12 to 16 procedures per hour. These programs "offer real hope for reducing the global burden of cataract blindness," Dr. Chang explained.
"The surgical solution is low tech—a manual extracapsular cataract extraction performed through a temporal, sutureless small incision," he said. "Equally important are the ability to manufacture affordable, low-cost IOLs, viscoelastics, and supplies and the streamlining of the surgical process through the use of standardized protocols executed by well-trained ancillary staff. Such cost containment and efficiency maximize the productivity of the system's most precious asset—the cataract surgeon."
Most importantly, the extracapsular procedure is affordable, Dr. Chang explained. For example, the five Aravind Eye Hospitals have used this technique for years to provide charitable cataract surgery at a cost of less than $15 per case. Charitable procedures account for roughly 200,000 annual cataract surgeries performed within the Aravind system. Research has shown that the complication rates for manual small-incision cataract surgery are low and that the procedure effectively restores vision in these populations.
Ophthalmologists at Aravind, Tilganga, and Project Vision are training surgeons from other developing countries on methods of performing high-volume manual small-incision cataract surgery. "We in the West need to help sustain this movement with financial and educational support," Dr. Chang advised.
In closing, Dr. Chang thanked the leaders of Aravind, Tilganga, and Project Vision "for their continually reminding me that, despite the fact that our own society, based on declining reimbursement, seems to value what we do less and less . . . good cataract surgeons remain one of the most precious and valuable assets for any society."
Aspheric NTIOL Released
STAAR Surgical Company (Monrovia, CA) released the Afinity Collamer Aspheric Single Piece New Technology IOL (NTIOL). The lens is delivered into the eye through a 2.2-mm microincision with STAAR's Nanopoint Injector System. The IOL's collamer material is composed of collagen, a UV-absorbing chromophore, and a poly(hydroxyethyl methacrylic) acid or poly(HEMA)-based copolymer.
Due to the lens' NTIOL status, which was granted by the Centers for Medicare & Medicaid Services, ambulatory surgery centers will receive an additional $50 reimbursement for every Afinity Collamer Aspheric Single Piece IOL that is implanted.
The first shipments of the Collamer Single Piece Aspheric NTIOL will go to STAAR's Collamer Accommodating Study Team (CAST), which was formed in 2008 and is composed of nine ophthalmologists. The CAST group collaborated with the company's development team to evaluate the baseline accommodative ability and properties of the collamer lens technology. The CAST physician group will benchmark patient outcomes.
In other news, STAAR implemented a new pricing policy, which includes a $100 reduction in the list price of its toric IOLs.
Wavefront-Guided LASIK Outperformed Conventional LASIK in Night-Driving Simulator Experiment
A retrospective review of two prospective clinical studies found that, compared with conventional LASIK, wavefront-guided LASIK combined with a flap created with a femtosecond laser significantly improved night-driving visual performance for patients with moderate myopia.1
The study was conducted by Steven C. Schallhorn, MD, of the Navy Refractive Surgery Center in San Diego and colleagues. It included eyes with a preoperative manifest spherical equivalent between -4.50 and -6.00 D that underwent a test that simulated driving at 55 miles per hour on a rural road at night. Sixty-two eyes (38 patients) underwent conventional LASIK (mean -5.46 D manifest spherical equivalent), and 36 eyes (21 patients) underwent wavefront-guided LASIK (mean -5.20 D manifest spherical equivalent). The distance at which subjects detected and identified road hazards was measured with and without a glare source before and 6 months after the LASIK procedure.
The researchers found that between 2% to 7% of conventional LASIK eyes compared with 11% to 31% of wavefront guided-LASIK eyes had a significant improvement in night-driving simulator performance.
Tecnis IOL More Effective at Near and Distance Than Monofocal Lens
The Tecnis Multifocal IOL (Abbott Medical Optics Inc., Santa Ana, CA) provided better near vision and better simultaneous vision at distance and near than a control monofocal IOL, according to the results of US clinical studies. Mark Packer, MD, of Drs. Fine, Hoffman & Packer, LLC, in Eugene, Oregon, presented the findings at the 2009 ASCRS Symposium on Cataract, IOL and Refractive Surgery in San Francisco.1
Four to 6 months after undergoing bilateral implantation, 88% of patients with the Tecnis Multifocal IOL (n = 292) said that they never wore spectacles. Only 5% of the patients who received a monofocal IOL (n = 118) reported similar results. For distance vision, 94.9% of the Tecnis Multifocal patients and 83.1% of the monofocal patients were spectacle independent. Close to 94% of the Tecnis Multifocal patients were spectacle free for near vision versus 5.1% of the monofocal patients. The ability of the Tecnis Multifocal patients to function comfortably without glasses was statistically significant for near vision compared with the monofocal patients at 4 to 6 months (94.2% vs 16.9%) and at 1 year (96.4% [n = 112] vs 30.4% [n = 115]). Moreover, 94.2% of the Tecnis Multifocal patients achieved 20/25 or better binocular distance BCVA and 20/32 or better binocular near photopic BCVA at 4 to 6 months.
Mark Packer, MD, is a consultant to Abbott Medical Optics Inc.
Improved Range of Vision Achieved With the AcrySof IQ Restor IOL +3.0 D
A prospective, randomized study found that the AcrySof IQ Restor IOL +3.0 D (Alcon Laboratories, Inc., Fort Worth, TX) provided patients with a better range of reading vision compared with the AcrySof IQ Restor IOL +4.0 D (Alcon Laboratories, Inc.). Robert Cionni, MD, shared these data at Alcon's booth during the annual ASCRS meeting as part of his presentation, "ReThink. ReDefine. ReDiscover. AcrySof IQ ReSTOR IOL +3.0 D Premium Technologies for Cataract Removal." Dr. Cionni is the medical director of the The Eye Institute of Utah in Salt Lake City.
The study included 300 patients implanted bilaterally with the AcrySof IQ Restor IOL +3.0 D (n = 150) or the AcrySof IQ Restor +4.0 D (n = 150). Distance and near vision was comparable between the two lenses, with a slight trend toward better near vision with the +3.0 D lens. Patients implanted with the +3.0 D IOL gained one to two lines of intermediate vision compared with patients who received the +4.0 D IOL. Ninety percent of patients implanted with the +3.0 D lens compared with 50% of patients implanted with the +4.0 D lens saw 20/30 or better at all three distances. Contrast sensitivity was reportedly similar for both groups. Of the patients implanted with the AcrySof IQ Restor IOL +3.0 D, 95% claimed that they would have the lens implanted again, Dr. Cionni said.
Robert Cionni, MD, is a consultant to, is on the speakers' bureau of, and receives research support from Alcon Laboratories, Inc.
Artificial Tears Effective for Dry Eye Management After LASIK
Optive Sensitive Preservative-Free Lubricant Eye Drops (Allergan, Inc., Irvine, CA) were safe and effective for the management of dry eye symptoms following LASIK, according to a poster presented at the ASCRS annual meeting in San Francisco.1
In a multicenter, double-masked trial, investigators randomized patients with no preexisting dry eye to use Optive Sensitive (n = 114 eyes of 228 patients) or Allergan's Refresh Plus (n = 114 eyes of 228 patients) for 90 days after LASIK. Dry eye symptoms were evaluated before surgery and 2, 14, 30, 60, and 90 days after LASIK.
Researchers found that the mean ocular surface disease index and corneal fluorescein staining scores followed a similar trend in both groups. They peaked on days 2 and 14, respectively, and then steadily decreased through day 90. The difference between the groups was statistically significant (P=.033). Patients who used Optive Sensitive experienced less ocular surface staining 2 weeks after surgery when compared with patients who used Refresh Plus (P=.039). Both groups had similar improvement trends from baseline in UCVA and continuously decreased their use of artificial tears from day 14 to day 90 (P<.001).
LUMINATE Trials Produced Positive Results for Uveitis Therapy
Results from three phase 3 LUMINATE (Luveniq Uveitis Multicenter Investigation of a New Approach to Treatment) trials of Luveniq (LX211; Lux Biosciences, Inc., Jersey City, NJ) for the treatment of uveitis found that the drug effectively and safely reduces ocular inflammation, according to a company news release.
Luveniq, which is licensed by Lux Biosciences from Isotechnika, Inc. (Edmonton, Alberta, Canada), is a next-generation calcineurin inhibitor designed for use as a voclosporin-based oral immune-modulatory agent to treat systemic forms of noninfectious uveitis. Patients treated with Luveniq can reportedly taper their use of systemic corticosteroids to 5 mg or less per day.
The three randomized, double-masked, dose-ranging, placebo-controlled trials enrolled 558 patients at 56 sites in seven countries (the United States, Canada, the United Kingdom, France, Germany, Austria, and India). Two hundred eighteen patients with noninfectious posterior uveitis (LX211-01), 232 patients with clinically quiescent uveitis (LX211-02), and 108 patients with anterior uveitis (LX211-03) were included in the trials. Patients in each study were randomized to receive 0.2, 0.4, or 0.6 mg/kg of Luveniq b.i.d. or placebo.
Of the three dosages, 0.4 mg/kg b.i.d. was the most safe and efficacious. In study LX211-01, the 0.4-mg/kg b.i.d dosage demonstrated superiority to placebo for mean change in vitreous haze at weeks 16 (P=.008) and 24 (P=.04). In study LX211-02, Luveniq was 50% more effective than placebo in reducing the rate at which inflammation recurred (P=.046). During the first 6 months, 22% of patients in the Luveniq group and 44% of patients in the placebo group experienced a flare. In study LX211-03, the efficacy of the three dosage groups and placebo were indistinguishable during the steroid taper. Patients in all four treatment arms showed an improvement of greater than one step mean reduction from baseline in anterior chamber cells.
In terms of ocular safety, the 0.4-mg/kg b.i.d. dosage did not affect IOP, cataract formation, or endothelial cellular density. Adverse effects associated with the dosage included minor renal complications, a mean increase of 6 mm Hg in systolic blood pressure, headache, diarrhea, and infections. Adverse events associated with the calcineurin inhibitor class (such as diabetes, elevation of lipids, hypomagnesemia, and tremor) were not observed.
Topical Bevacizumab Reduced Growth of Corneal Blood Vessels
Short-term topical bevacizumab (Avastin; Genentech, Inc., San Francisco, CA) therapy reduced the severity of corneal neovascularization without adverse local or systemic effects, according to researchers at the Massachusetts Eye and Ear Infirmary and Schepens Eye Research Institute in Boston.1
In a prospective, open-label, noncomparative study, 10 eyes of 10 patients with stable corneal neovascularization were treated with topical bevacizumab, 1.0%, for 3 weeks and observed for up to 24 weeks. The investigators reported a reduction in neovascular area (mean 47.1% ±36.7%; P=.001) and vessel caliber (mean 54.1% ±28.1%; P<.001) from baseline to the final
follow-up. The decrease in neovessel invasion area (12.2% ±42.0%; P=.19) did not achieve statistical significance, and visual acuity and central corneal thickness did not change significantly. However, topical bevacizumab was well tolerated and did not affect mean arterial pressure throughout the study, and no adverse events were reported.
"These are important and exciting data since corneal neovascularization accounts for the second leading cause of blindness worldwide, after cataracts," the study's senior author Reza Dana, MD, MSc, MPH, said in a news release. "The excellent efficacy and safety data in this study means that we can now offer select patients who get growth of new blood vessels in their corneas, from infection or injury, a new promising treatment." Dr. Dana is the director of the Cornea Service at Massachusetts Eye and Ear Infirmary and the Claes Dohlman professor of ophthalmology at Harvard Medical School.
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