Purpose: To compare the safety and efficacy of a hydrogel bandage and a collagen corneal shield in providing wound protection and relief of pain/discomfort in the acute period after uneventful unilateral clear corneal phacoemulsification cataract surgery with foldable intraocular lens (IOL) implantation.
Setting: Seventeen investigational sites in the United States.
Design: Prospective randomized single-masked parallel study.
Methods: The study comprised patients scheduled to have unilateral clear corneal cataract surgery with posterior chamber intraocular lens implantation. The patients were examined preoperatively and frequently for 30 days postoperatively. The design was a noninferiority study of the 2 primary endpoints, device performance and maximum reported postoperative pain.
Results: The device performance success was 78.6% (228/290) for the hydrogel bandage and 26.5% (26/98) for the corneal shield (P<.0001 for noninferiority). Analyses indicated that the hydrogel bandage was superior to the corneal shield in device performance (P<.001; difference = 52.1%; 95% confidence interval, 41.6%-61.4%). The maximum postoperative pain/discomfort score of the hydrogel bandage (mean 1.3 ± 1.8 [SD]; scale 0 to 10) was noninferior to that of the corneal shield (1.1 ± 1.6) in the first 4 hours after surgery (P<.001). Adverse events in the cataract surgeries were reported in 22.2% (70/316) and 36.5% (38/104) of hydrogel bandage patients and corneal shield patients, respectively (P = .0045).
Conclusion: The hydrogel bandage was safe and effective for ocular surface protection and relief of pain/discomfort when applied topically to clear corneal incisions used in cataract or IOL implantation surgery.
Financial disclosure: No author has a financial or proprietary interest in any material or method mentioned. Additional disclosures are found in the footnotes.
Trial registration: ClinicalTrials.gov NCT00774228.
Copyright © 2011 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.