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

Ofer Daphna, Michael Mimouni, Yariv Keshet, Meydan Ben Ishai, Irina S Barequet, Boris Knyazer, Ewa Mrukwa-Kominek, Tomasz Zarnowski, Malca Chen-Zion, Arie Marcovich, Ofer Daphna, Michael Mimouni, Yariv Keshet, Meydan Ben Ishai, Irina S Barequet, Boris Knyazer, Ewa Mrukwa-Kominek, Tomasz Zarnowski, Malca Chen-Zion, Arie Marcovich

Abstract

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.

Conflict of interest statement

Dr. Daphna is the founder and medical director of EyeYon Medical. Dr. Mimouni and Dr. Marcovich are consultants for EyeYon Medical. The rest of the authors have no conflicts of interest to declare.

Copyright © 2020 Ofer Daphna et al.

Figures

Figure 1
Figure 1
Therapeutic Hyper-CL™ lens design. The lens design consists of a dual base curve, fenestrations, and a reservoir for accumulation of therapeutic solutions.
Figure 2
Figure 2
High molecular-weight fluorescein accumulation. Saline stained with high molecular weight fluorescein was applied on the Therapeutic Hyper-CL™ surface while on the patient eye. The high molecular weight fluorescein does not penetrate the lens matrix; thus, a high fluoresce pattern demonstrates the accumulation of 5% salt solution or any other therapeutic eye drops under the lens. This fluorescing pattern was shown to last on the eye for 10–20 minutes.
Figure 3
Figure 3
Anterior segment optical coherence tomography. The potential reservoir is demonstrated by anterior segment optical coherence tomography.

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Source: PubMed

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