Therapeutic HL-Contact Lens versus Standard Bandage Contact Lens for Corneal Edema: A Prospective, Multicenter, Randomized, Crossover Study

Abstract EN

Introduction.

To compare the safety and efficacy of the Therapeutic Hyper-CL™ lens versus a standard bandage contact lens (PureVision B&L) for chronic corneal edema.

Methods.

Prospective, multicenter, randomized, crossover study.

Chronic corneal edema patients were randomized to one of two arms.

The first arm was fitted with the Therapeutic Hyper-CL™ lens while the second arm was fitted with a standard soft bandage contact lens.

Both arms were treated with 5% sodium chloride 6 times a day.

After a 7-day treatment period, there was a 7-day washout period, after which the arms were crossed over.

Patients were evaluated at days 0 (baseline), 7 (following first treatment allocation), 14 (following washout), and 21 (following second treatment allocation).

The primary outcomes were 3 lines of BCVA (best corrected visual acuity) improvement.

Results.

In total, 49 patients were enrolled.

There was significantly greater BCVA improvement rate >3 lines (30.4% versus 17.4%, P=0.04) in the Therapeutic Hyper-CL™ lens group.

The mean change in BCVA lines was significantly greater for the Therapeutic Hyper-CL™ lens (3.4 ± 6.7 versus 0.9 ± 2.3, P=0.02).

Conclusions.

The Therapeutic Hyper-CL™ lens was associated with a higher chance for significant visual acuity improvement when compared to a standard bandage contact lens combined with 5% sodium chloride.

This trial is registered with NCT02660151.