This is a supplement to EyeWorld Magazine.
Issue link: https://supplements.eyeworld.org/i/319341
EW Boston 2014 3 Forty-four percent were men, and 56% were women. Eyes with prior refractive surgery, significant lentic- ular astigmatism, abnormal topogra- phies, a calculated residual stromal bed thickness less than 250 µm, or other ocular pathology that might affect the results of LASIK were excluded. Postoperative examinations were performed at day 1, week 1, and months 1, 3, 6, 9, and 12. Visual acuities and refractive errors were measured with the Early Treatment Diabetic Retinopathy (ETDRS) charts and protocol. The study found that topogra- phy-guided treatment resulted in a significant reduction in manifest re- fraction spherical equivalent (MRSE) and cylinder, reaching stability at 3 months after treatment. Mean MRSE was 0.06±0.33 D at 3 months and 0.00±0.27 D at 1 year. Mean cylinder was 0.19±0.32 D at 3 months and 0.19±0.30 D at 1 year. Three months postoperatively, 91.9% of eyes were within 0.50 D of plano, and at 1 year, 94.8% of eyes were within 0.50 D of plano. At 3 months postoperatively, 7.7% of eyes saw 20/10 or better without correction; 31.6% of eyes saw 20/12.5 or better; 68.8% of eyes saw 20/16 or better; 92.7% of eyes saw 20/20 or better; and 97.2% of eyes saw 20/25 or better. At 1 year, 15.7% of eyes saw 20/10 or better without correction; 34.4% of eyes saw 20/12.5 or better; 64.8% of eyes saw 20/16 or better; 92.6% of eyes saw 20/20 or better; and 96.5% of eyes saw 20/25 or better. Eyes treated with topography-guided treatment achieved an improvement in UCVA compared to preoperative BSCVA, with 29.6% of eyes gaining 1 or more lines of UCVA, and 89.9% of eyes seeing at least as well without correction postoperatively as they did with best spectacle correction preoperatively (Figure 1). The safety of topography-guided treatment was excellent, with only 5 single reports of loss of BSCVA of two or more lines at 1 month or later. One patient suffered bilateral retinal detachments 6 months after topography-guided treatment. Com- plications were transient and did not result in significant loss of vision. In fact, there was a tendency toward an improvement in BSCVA after topography-guided treatment, compared to preoperatively, with a trend toward further improvement with time (Figure 2.) Most visual symptoms improved at 3 months after topography-guided treatment compared to preoperative levels with habitual correction, reaching statistical significance for light sensitivity, difficulty driving at night, reading difficulty, and glare. Only double vision and foreign body sensation were reported as worse after 3 months, with minimal in- creases of 0.8% and 0.4%, respec- tively. The incidence and severity of visual symptoms continued to decline during the 12 months of the study (Figure 3). The Refractive Status and Vision Profile (RSVP) showed an improve- ment in all subscales and in the total composite score that is computed for each visit, including physical/ social functioning, driving, visual symptoms, optical problems, and problems with corrective lenses that were evident at 3 months and continued to improve through 12 months postoperatively, compared to their vision while wearing glasses or contact lenses preoperatively. The only exception was glare at the 1-month visit, which showed a worsening that changed to im- provement at 3 months and all subsequent visits. Published literature has indi- cated that a difference of 6 points or more on the composite score is a clinically significant change, 2 so the difference in composite score from baseline to each postoperative visit showed a clinically significant im- provement in the RSVP profile, with a mean improvement that is nearly 3 times the minimum threshold for clinically significant improvement at each postoperative visit, ranging from a change of –15.97 points at 3 months to a change of –16.39 points at 12 months. Most of these patients (98.4%) were satisfied with their outcomes and said they would have topography-guided treatment LASIK treatment again. The results of this study exceeded our expectations. We thought that we would see good outcomes but did not think that topography-guided treatment on "normal" eyes without significant topographic abnormalities would exceed the outcomes we are accus- tomed to seeing with currently avail- able treatments. To our surprise, we found excellent UCVA, significant improvements in BSCVA, and a reduction in visual symptoms. In fact, a majority of eyes had better postoperative UCVA than preopera- tive BSCVA. I feel that topography- guided treatment should be considered as a first-line treatment for the reduction of myopia and astigmatism within the approved FDA ranges. We have come a long way with corneal refractive surgery in the past 2 decades. The days when we had to warn patients that loss of BSCVA and visual aberrations might be the price they would have to pay for spectacle independence have passed. With topography-guided treatment, we should tell our patients there is an excellent likelihood that they will have better vision without correc- tion than they had preoperatively with correction and that the quality of their vision is likely to improve. We can now be confident that topography-guided treatment is likely to have a positive impact on quality of life of our patients. Reference 1. Summary of Safety and Effectiveness Data PMA P020050/S12 2. Schein, OD, et al. Patient outcomes of refractive surgery. The refractive status and vision profile. J Cataract Refract Surg. 2001; 27(5):665-73. Dr. Stulting is affiliated with the Stulting Research Center at Woolfson Eye Institute, Atlanta. He can be contacted at dstulting@woolfsoneye.com. *Trademarks are property of their respective owners. continued from page 1 Figure 2: Postop BSCVA compared to preop BSCVA (change in lines) Figure 3: Visual symptoms: preop to 3 M, n=247