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The Hyper-CL™ multi-center study

Poster Details

First Author: O.Daphna ISRAEL

Co Author(s):                        

Abstract Details

Purpose:

To evaluate the safety and efficacy of the Hyper-CL™¢ lens in subjects suffering from corneal edema and to compare the efficacy of the Hyper-CL™ lens to standard treatment with regular contact lens. The Hyper-CL therapeutic soft contact lens has a unique design that enable the capture and delivery of a drop applied on its surface resulting in increased contact time with the corneal surface.

Setting:

Multi-center study: 4 centers: 2 centers in Israel: Soroka Medical Center, Shiba Medical center. 2 centers in Poland: Medical University Of Silesia Katowice, Independent Public University Hospital no.1 Lublin

Methods:

Prospective, randomized crossover study of the HCL in subjects suffering from corneal edema. Each patent was treated in a randomized fashion through the following steps: • Treatment A: Hyper-CL lens + salt solution 4/d (7 days) • One week of washout • Treatment B: Regular therapeutic lens + salt solution 4/d (7 days) Best corrected visual acuity(ETDRS) pachymetry and comfort were documented.

Results:

Up to date 41 patient were included. the mean visual improvement while using the HCL was 1.7 ETDRS lines and 0.4 ETDRS lines while using control bandage contact lens. The mean reduction in corneal thickness was 49 (SD: 117) µm and 10 (SD: 67) µm with the Hyper-CL and control lens respectively, corresponding to a mean reduction of 4.26% (SD: 11.38%) with the Hyper-CL lens and 0.59% (SD: 13.91%) with the standard lens. No serious adverse events occurred while using the Hyper-CL.

Conclusions:

In our primary results there is a tendency for a decrease in corneal pachymetry and an increase in visual acuity while treating with the HCL salt solution. This method of treatment is seems to be superior to the current standard of treatment, using salt water and a regular bandage contact lens

Financial Disclosure:

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

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