DALLAS--(EON: Enhanced Online News)--The American Refractive Surgery Council (ARSC) is available to provide perspective and context on the recently published JAMA Ophthalmology PROWL study - our members, who include surgeons from American Society for Cataract and Refractive Surgery, American-European Congress of Ophthalmic Surgery and the Refractive Surgery Alliance - are immediately available.
“PROWL studies were primarily designed with an adequate sample size to evaluate the questionnaire rather than to report on outcomes.”
The study was designed to develop and test a new patient reported questionnaire, that, for the first time, makes it possible for patients to report and surgeons to scientifically track their experiences after LASIK.
“What PROWL has delivered is a new systematic way of collecting the patient’s subjective perceptions, which are incredibly valuable to the delivery of care,” said Kerry Solomon, M.D., President of ASCRS and member of ARSC. “The potential to expand our clinical understanding of LASIK with patient reported data is very exciting. We anticipate the ongoing use of the PROWL questionnaire will provide important insights that can improve what is already a fantastic vision correction option for those who are good candidates.”
Additionally, while the study acknowledges the safety and effectiveness of LASIK is well documented; it also states that the “PROWL studies were primarily designed with an adequate sample size to evaluate the questionnaire rather than to report on outcomes.” The study acknowledges the sample size is too small to generalize findings to everyone having LASIK; the follow up is much too short and no enhancements were performed.
An unfortunately confusing interpretation of the findings has led to the reporting of an erroneous statistic on side effects, overshadowing the very important primary work of the study – the development of the scientifically valid questionnaire and the valuable information it provides. The PROWL studies found that a small group of participants – those who reported having no symptoms prior to LASIK (PROWL-1: n=75, PROWL-2: n=68) - reported new visual symptoms following LASIK. The actual PROWL data on the development of new symptoms from this subset are1:
- At three months post op, 43 percent (n=32 participants) of this small subset of the PROWL-1 participants reported experiencing at least one new symptom.
- At six months post op, that number further decreased to 36 percent (n=26 participants) in the PROWL-1 study.
- At three months post op, 46 percent (n=31 participants) of the same subset (n=68) of the PROWL-2 participants reported experiencing at least one new symptom.
1 Ref Table 3: Symptom Development: No Symptoms of any type to at least 1 symptom – Page E6 of the JAMA Ophthalmology study
We support the PROWL study conclusion for continued education and patient counseling about the risks and benefits of LASIK. ARSC offers a wealth of information on vision correction procedures designed for people considering their vision correction options. To learn more about ARSC, please visit www.americanrefractivesurgerycouncil.org/blog.