Quality of Vision and Overall Satisfaction in Patients Implanted With Clear Hydrogel Corneal Inlay

Sunday, April 19, 2015: 3:36 PM
Room 1A (San Diego Convention Center)
Jeffrey Whitman, MD

To evaluate quality of vision and overall satisfaction in patients unilaterally implanted with the Raindrop Near Vision Inlay, an investigational device designed to correct presbyopia (ReVision Optics, Inc.). This empirical data review will look at various endpoints that influence postoperative quality of vision and patient satisfaction.

As part of a multi-center, prospective FDA study, 80 of 82 subjects from one clinical site have reached the 12M visit. ETDRS acuities were collected at various distances preoperative, 1W, 1M, 3M, 6M, 9M, and 12M. Visual symptoms, visual task performance, and patient satisfaction were evaluated with a validated NEI questionnaire.

Binocularly at 12M, nearly all patients were 20/20 or better (94% UNVA, 100% UDVA). Monocularly, 98% of patients were 20/25 or better UNVA and 96% of patients were 20/32 or better (UDVA). Reports of moderate or worse visual symptoms were minimal (0% glare, 2% halos) at 12M. NEI questionnaire showed no increase in difficulty driving at night, 76% preop to 75% at 12M reported no difficulty at all. 96% patients reported being satisfied or very satisfied.

Raindrop Inlay provided my patients with good near acuity without glasses. Binocularly, nearly all patients achieved 20/20 or better at near and distance. A combination of visual performance and minimal visual symptoms achieved 96% patient satisfaction.

* CAUTION: Investigational device. Limited by Federal United States law to investigational use.