Non-refractive corneal Inlay for the treatment of presbyopia: US FDA clinical trial update

Session Details

Session Title: Intracorneal Inlays for Presbyopia

Session Date/Time: Tuesday 08/09/2015 | 16:00-18:00

Paper Time: 16:00

Venue: Main Auditorium

First Author: : R.Steinert USA

Co Author(s): :                        

Abstract Details

Purpose:

To evaluate visual outcomes and overall satisfaction in emmetropic presbyopes unilaterally implanted with a transparent hydrogel corneal inlay (Raindrop Near Vision Inlay, ReVision Optics, Inc., Lake Forest, CA) as part of a US FDA IDE study.

Setting:

Gavin Herbert Eye Institute, UC Irvine, CA USA

Methods:

As part of a multi-center, non-randomized, prospective FDA IDE study, 373 subjects were enrolled into the study. ETDRS visual acuities were collected at various distances preoperative, 1W, 1M, 3M, 6M, 9M, 12M, 18M, and 24M postoperatively. Ocular symptoms and patient satisfaction were evaluated with a validated NEI Quality of Life questionnaire. Endothelial cell loss (ECL) and explant rates will also be analyzed.

Results:

At one year (n=340), almost all patients achieved 20/25 or better binocular uncorrected acuity at distance (100%) and near (95%). On average in the inlay eye, UNVA improved by 5.1 lines, UIVA by 2.5 lines, and UDVA decreased by 1.2 lines. Overall patient satisfaction was high at 93%. Complications were low with 3.2% explant rate. All explanted patients were 20/25 or better (CDVA) 3 months after inlay removal.

Conclusions:

Raindrop Inlay provided patients with good acuity (near and distance) with 95% of patients seeing 20/25 or better at all distances at 12M. A combination of good visual performance and minimal complications ultimately achieved high patient satisfaction of 93%.

Financial Interest:

One of the authors receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented