Overall satisfaction in patients implanted with a hydrogel corneal inlay

Session Details

Session Title: Presbyopic Corrections

Session Date/Time: Monday 15/09/2014 | 16:30-18:30

Paper Time: 16:54

Venue: Boulevard F (Level 1)

First Author: : J.Whitman USA

Co Author(s): :                  

Abstract Details

Purpose:

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

Setting:

Key-Whitman Eye Center (KWEC) 2801 Lemmon Avenue, Suite 200 Dallas, Texas 75204 Ph: 214.754.0000 Whitman@keywhitman.com

Methods:

As part of a multi-center, prospective FDA IDE study, 45 of 82 subjects from one clinical site (KWEC) have reached the 12M visit. ETDRS visual acuities were collected at various distances preoperative, 1W, 1M, 3M, 6M, 12M postoperative. Visual symptoms, visual task performance, and patient satisfaction were evaluated via patient response including the validated NEI Quality of Life questionnaire.

Results:

: Binocularly, 100% of patients were 20/20 or better UNVA and UDVA at 12M. Monocularly, 98% of patients were 20/25 or better UNVA and 82% of patients were 20/25 or better (UDVA) at 12M. No reports of visual symptoms (i.e. halos, glare) occurred at 12M. NEI questionnaire showed no increase in difficulty driving at night, no difficulty at all: 76% preop to 76% 12M. Overall 1 year patient satisfaction was high at 98% being satisfied or very satisfied.

Conclusions:

Raindrop Inlay provided most patients with good near acuity to perform daily tasks without glasses. Binocular distance acuity remains unchanged from preop and provided consistent distance task performance. A combination of visual performance and no visual symptoms ultimately achieved high patient satisfaction of 98%.

Financial Interest:

NONE