The Hyper-CL™ multi-center study

Session Details

Session Title: Cornea Miscellaneous

Session Date/Time: Monday 24/09/2018 | 16:30-18:00

Paper Time: 17:03

Venue: Room A3, Podium 3

First Author: : A.Marcovich ISRAEL

Co Author(s): :    O. Daphna                    

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:

Multy Center Study: 2 centers in Israel and 2 centers in Poland

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 only + salt solution (7 days) • One week of washout • Treatment B: Regular theraputic lens + salt solution (7 days) Best corrected visual acuity(ETDRS) pachymetry and comfort were documented.

Results:

A total number of 49 patients were treated at four different sites. Visual acuity improvements of ≥1 line were achieved in 48.9% (23/47) of the subjects while using the Hyper-CL lens versus 38.6% (17/44) when using the standard lens. Visual acuity improvements of ≥3 lines were measured in 29.8% (14/47) of the subjects while using the Hyper-CL lens versus 11.4% (5/44) when using the standard lens. The mean change in corneal thickness was -41.0±106.0 µm versus -1.0±70.0 µm for the Hyper-CL and control lens, respectively. Both lens types proved equally safe and tolerable.

Conclusions:

While practicing the same technique using contact lens and hyperosmotic solution, the Hyper-CL™ lens was associated with a higher chance for significant visual acuity improvement as compared to a standard lens, with a similar risk and comfort profile.

Financial Disclosure:

... gains financially from product or procedure presented