Shaping a profocal cornea using a hydrogel inlay: clinical trial update

Session Details

Session Title: Presbyopic Corrections

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

Paper Time: 17:22

Venue: Boulevard F (Level 1)

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, and 18M postoperatively. Visual symptoms, visual task performance, and patient satisfaction were evaluated with a validated NEI Quality of Life questionnaire.

Results:

Binocularly at 12M, 93% of patients were 20/25 (0.8) or better at all distances (near, intermediate, and distance). Monocularly at 12M in the inlay eye, 93% of patients had UNVA of 20/25 (0.8) or better and 85% of patients had UDVA of 20/32 (0.63) or better. Low (<6%) visual symptoms (halos and glare) were reported at 12M. Overall patient satisfaction was high at 94% being Somewhat Satisfied, Very Satisfied, or Completely Satisfied.

Conclusions:

Raindrop inlay provided most patients with good monocular acuity at all distances. Binocular acuity was even better, with 93% of patients seeing 20/25 (0.8) or better at all distances at 12M. A combination of good visual performance and low visual symptoms ultimately achieved high patient satisfaction of 94%.

Financial Interest:

One or more of the authors... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, One or more of the authors... travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented