Implantation of an Artificial Endothelial Layer for Treatment of Chronic Corneal Edema.

PURPOSE: The purpose of this study was to describe a novel device that may serve as an alternative to Descemet membrane endothelial keratoplasty (DMEK) for the treatment of chronic corneal edema. METHODS: The EndoArt (EyeYon Medical, Israel) is a flexible, 50-µm thin artificial endothelial layer that matches the cornea's posterior curvature and functions as a fluid barrier at the posterior stroma, replacing the diseased endothelium. Similar to a DMEK approach, it is implanted into the anterior chamber, carefully positioned on the posterior stroma, and secured using an air-gas mixture. Two patients with chronic corneal edema resulting from endothelial decompensation underwent implantation of the new artificial lamella. RESULTS: In patient 1, the central corneal thickness (CCT) decreased from 730 µm preoperatively to 593 µm at 1 day postoperatively. In patient 2, the CCT decreased from 761 µm preoperatively to 487 µm at 1 day postoperatively. Both patients reported high satisfaction and an overall brighter visual quality. Although dislocation of the lamella occurred in both cases, the CCT was promptly restored after a repositioning procedure and remained stable at the 17-month follow-up (CCT of 526 and 457 µm for patients 1 and 2, respectively). In contrast to DMEK donor tissue, the artificial lamella is sufficiently robust to allow easy intraocular manipulation without the risk of damaging the implant. It is easily removable and does not require any immunosuppressive treatment because of its nonbiological nature. CONCLUSIONS: Implantation of the EndoArt led to rapid corneal deturgescence and CCT restoration, presenting a possible option for patients with chronic corneal edema.

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

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.

Stiffening of rabbit corneas by the bacteriochlorophyll derivative WST11 using near infrared light.

PURPOSE: We evaluated the efficacy and safety of photochemical corneal stiffening by palladium bacteriochlorin 13'-(2-sulfoethyl)amide dipotassium salt (WST11) and near infrared (NIR) illumination, using ex vivo and in vivo rabbit eye models. METHODS: Corneas of post mortem rabbits and living rabbits were pretreated topically with 2.5 mg/mL WST11 in saline or in 20% dextran T-500 (WST-D), washed and illuminated with an NIR diode laser (755 nm, 10 mW/cm(2). Studies with corneas of untreated fellow eyes served as controls. Tensile strength measurements, histopathology, electron spin resonance, and optical spectroscopy and fluorescence microscopy were used to assess treatment effects. Comparative studies were performed with standard riboflavin/ultraviolet-A light (UVA) treatment. RESULTS: WST11/NIR treatment significantly increased corneal stiffness following ex vivo or in vivo treatment, compared to untreated contralateral eyes. The incremental ultimate stress and Young's modulus of treated corneas increased by 45, 113, 115%, and 10, 79, and 174% following 10, 20, and 30 minutes of incubation with WST11, respectively. WST-D/NIR had a similar stiffening effect, but markedly reduced post-treatment edema and shorter time of epithelial healing. WST11/NIR and WST-D/NIR generate hydroxyl and superoxide radicals, but no singlet oxygen in the cornea. Histology demonstrated a reduction in the keratocyte population in the anterior half of the corneal stroma, without damage to the endothelium. CONCLUSIONS: Treatment of rabbit corneas, with either WST11/NIR or WST-D/NIR, increases their biomechanical strength through a mechanism that does not involve singlet oxygen. The WST-D/NIR treatment showed less adverse effects, demonstrating a new potential for clinical use in keratoconus and corneal ectasia after refractive surgery.