EyeWorld India June 2015 Issue

50 EWAP REFRACTIVE June 2015 looking at things like ghosting, glare, halos, and starbursts, the preop values were significantly higher compared to postop, Dr. Manche said. It is incredible to note that this data is one treatment with no enhancement surgery, he said. Further study “We need to remember that the purpose of the PROWL studies was to develop a questionnaire to assess visual symptoms, not to evaluate the safety and efficacy of LASIK,” Dr. Stulting, who is chair of the ASCRS Refractive Surgery Clinical Committee, said. “Outcomes were measured 3 months (PROWL 2) or 6 months (PROWL 2) after surgery— well before temporary side effects like dry eye resolve and the long- term visual effects are achieved. So it would be inappropriate and scientifically inaccurate to draw conclusions about LASIK outcomes on the basis of the PROWL studies. Nevertheless, the results of the PROWL studies are consistent with published studies showing the outstanding safety and efficacy of LASIK,” he said. “In our short-term natural history study (3 to 6 months) of LASIK, the percentage of subjects experiencing disabling symptoms was low,” Dr. Eydelman said. “Less than 1% of patients had symptoms that prevented them from doing their usual activities following LASIK. All patients contemplating LASIK should be informed of this small but significant risk. A very large clinical study would be necessary to more accurately estimate the prevalence and find useful predictors for these patients because there are so few. The FDA will make the questionnaire available to researchers interested in this area.” The studies show that there is a firm grasp on the symptoms that patients generally report after LASIK, Dr. Hofmeister said. “This understanding can and should permit surgeons to provide a more focused and effective informed consent to our LASIK patients,” she said. She hopes the questionnaire will be a useful tool for studying LASIK and other refractive procedures. The project was designed to develop and utilize a new questionnaire that assessed patients’ reported experiences before and after surgery, Dr. Eydelman said, which was not done in earlier studies. “In the future, the questionnaire we produced can be used to more thoroughly assess candidates before LASIK surgery; monitor them for visual symptoms after LASIK surgery; and in further research identify which patients are likely to experience serious difficulties,” she said. Dr. Eydelman said the study established a starting point for accurately assessing the impact of visual symptoms on subjects’ functioning, as well as determining how bothersome those symptoms are. “The findings from this study will help to refine [the] FDA’s current thoughts on the labeling for LASIK devices, which will be incorporated into our LASIK guidance,” Dr. Eydelman said. Additionally, the questionnaire content will be publicly available for use in clinical trials of LASIK devices, as a tool in clinical care, and for future research endeavors. There were some patients who experienced some negative effects in the study, but Dr. Eydelman noted that the percentage of subjects experiencing disabling symptoms was low. However, she said that anyone contemplating LASIK should be aware of this risk. Dr. Manche thinks that this was a well-designed study. However, he does take some issue with measuring symptoms at 3 months because they are not necessarily representative. This should have been carried out to a year, he said. “I think it’s a well-done study in that it was prospective in nature, multicenter, and it was done with the FDA and [National Eye Institute],” he said. The study provides good answers for those patients thinking of having LASIK, he said. EWAP Editors’ note: Drs. Eydelman, Manche, Hofmeister, and Stulting have no financial interests related to this article. Contact information Eydelman: malvina.eydelman@fda.hhs.gov Hofmeister: elizabeth.hofmeister@med.navy.mil Manche: edward.manche@stanford.edu Stulting: dstulting@woolfsoneye.com Index to Advertisers Alcon Page : 9, 11 , 13 www.alcon.com Haag-Streit Page: 25 www.haag-streit.com Moria Page: 31 , 35 www.moria-surgical.com OCULUS Optikgeräte Page: 17 www.oculus.de Rayner Intraocular Lenses Page: 27 www.rayner.com Topcon Corporation Page: 41 www.topcon.co.jp Ziemer Page: 76 www.ziemergroup.com ASCRS Page : 7, 36 , 47 , 49 , 61 www.ascrs.org APACRS Page: 2, 5, 52 , 58 , 68 , 75 www.apacrs.org FDA - from page 48