Author Interviews, FDA, JAMA, Ophthalmology / 02.12.2016

MedicalResearch.com Interview with: [caption id="attachment_30144" align="alignleft" width="200"]Malvina Eydelman, M.D. Division Director; Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health FDA. Dr. Malvina Eydelman[/caption] Malvina Eydelman, M.D. Division Director; Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health FDA. MedicalResearch.com: What is the background for this study? Response: In October 2009, the FDA, the National Eye Institute (NEI), and the Department of Defense (DoD) launched the LASIK Quality of Life Collaboration Project (LQOLCP) to help better understand the potential risk of severe problems that can result from LASIK. The project aimed to develop a tool to determine the percent of patients who develop difficulties performing their usual activities following LASIK, and to identify predictors for those patients. At the time we developed our project, there was a limited amount of valid scientific data on certain patient-reported outcomes (PROs) related to LASIK. A PRO is a report of a condition experienced and reported by the patient, not the health care provider. Most LASIK studies used tools, such as questionnaires, to assess visual symptoms, but only after the surgery. The Patient-Reported Outcomes with LASIK (PROWL) studies in the LQOLCP assessed visual symptoms both before and after their LASIK surgery to identify changes over time. The studies also measured the impact symptoms directly had on performing usual activities, which had not previously been done.
Author Interviews, Ophthalmology / 22.09.2014

Dr. David O'Brart Keratoconus Research Institute, Department of Ophthalmology St. Thomas' Hospital, London, United KingdomMedicalResearch.com Interview with: Dr. David O'Brart Keratoconus Research Institute, Department of Ophthalmology St. Thomas' Hospital, London, United Kingdom   Medical Research: What are the main findings of the study? Dr. O'Brart: There was a slight but significant increase in myopic spherical equivalent refractive error after Photorefractive Keratectomy between 1 and 20 years, particularly in those under 40 at the time of treatment and female patients. Corneal curvature/power remained unchanged but axial length increased over two decades. The procedure was safe with no long-term sight-threatening complications and improvements in CDVA (corrected distance visual acuity) and corneal transparency with time.