Transparent hydrogel corneal inlay for the correction of presbyopia: European clinical registry

Session Details

Session Title: Presented Poster Session: Corneal Inlays

Session Date/Time: Tuesday 08/09/2015 | 09:30-11:00

Paper Time: 09:40

Venue: Poster Village: Pod 2

First Author: : B.Cochener FRANCE

Co Author(s): :                  

Abstract Details

Purpose:

To assess multi-center clinical outcomes of patients implanted with Raindrop Near Vision Inlay for the correction of presbyopia.

Setting:

University Hospital Brest, France

Methods:

Prospective, multicenter, commercial registry on presbyopes implanted with Raindrop Inlay in the non-dominant eye under a femtosecond flap with and without concurrent LASIK. Inlay/LASIK group A (n=53) were treated for ametropia and targeted for slight hyperopia (+0.75 D) in the inlay eye. Inlay group B (n=48) were treated with inlay only, no LASIK ablation. Patients with moderate or worse ocular surface were not implanted, mild cases were treated aggressively. Visual acuities at various distances and patient satisfaction were collected at 1M, 3M, 6M, and 12M.

Results:

Average preoperative parameters showed no difference between Inlay/LASIK group A and Inlay group B (all p>0.05). At 1M, mean UVAs in the treated eye were similar at distance (A: 0.6, B: 0.6, p>0.05) and near (A: 0.8, B: 0.9 p>0.05). Binocular UVAs was better for group B at distance (A: 1.1, B: 1.2, p=0.05), with no difference at near (A: 0.9, B: 0.9 p>0.05). The Inlay group B was slightly more satisfied with their visual outcome (A: 82% vs. B: 95%). Early complications were low (2%) at 1M, 1 case of flap striae and 1 case of mild haze.

Conclusions:

Careful selection of qualified Raindrop patients yielded good visual performance at near with and without concurrent LASIK ablation. Distance vision was slightly reduced in the treated eye, but improves binocularly in both groups with slight advantage to the Inlay only group. Patient satisfaction was high, slightly better in the Inlay group. Early complications were low and manageable.

Financial Interest:

One of the authors travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented