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.
Highlights
Corneal edema, and associated loss of visual acuity, affects millions worldwide and is one of the most common complications of cataract surgery [1]
49 patients suffering from chronic corneal edema (21 males and 28 females), with an average age of 70.5 ± 11.3 years, were randomized to start either with the erapeutic
TM CL versus a standard bandage contact lens in management of corneal edema with secondary visual impairment. e proportion of patients achieving a significant improvement in Central corneal thickness (CCT) and BCVA was greater in the erapeutic Hyper
Summary
Therapeutic HL-Contact Lens versus Standard Bandage Contact Lens for Corneal Edema: A Prospective, Multicenter, Randomized, Crossover Study. To compare the safety and efficacy of the erapeutic Hyper-CL lens versus a standard bandage contact lens (PureVision B&L) for chronic corneal edema. E first arm was fitted with the erapeutic 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. E erapeutic 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. Conclusions. e erapeutic 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. is trial is registered with NCT02660151
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