Comparison of Efficacy and Safety of Two Commercial Artificial Tears Between 0.18% and 0.3% Sodium Hyaluronate for Corneal Epithelial Healing in Pterygium Excision with Conjunctival Autograft Transplantation: A Study Protocol for a Randomized Controlled Trial

比较两种市售人工泪液(0.18%和0.3%透明质酸钠)在翼状胬肉切除联合结膜自体移植术后促进角膜上皮愈合的疗效和安全性:一项随机对照试验的研究方案

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Abstract

PURPOSE: To compare the efficacy, safety, and rate of healing on the corneal epithelial defect after pterygium surgery through the application of either 0.18% or 0.3% sodium hyaluronate (SH). METHODS: A randomized, double-blind clinical trial was performed on patients who had pterygium surgery. Eighty-six patients were randomized to 2 groups that would receive either 0.18% SH or 0.3% SH. Measurements of area of the corneal epithelial defect using ImageJ freeware were performed. All corneal epithelial defects were measured immediately after the operation (Day 0) and for the next 3 days. RESULTS: The mean and SD of the area of corneal epithelial defect measured on postoperative Day 0, 1, and 2 were 9.13 ± 3.09 mm(2), 5.61 ± 3.26 mm(2), and 3.39 ± 2.70 mm(2) for 0.18% SH group, and 8.96 ± 3.17 mm(2), 4.03 ± 1.99 mm(2), and 1.55 ± 1.23 mm(2) for 0.3% SH group. There was no statistically significant difference of the initial area of the corneal epithelial defect on Day 0 between 0.18% and 0.3% SH group (p = 0.802). The area of the defects in the 0.3% SH group was significantly smaller than that of the 0.18% SH group on both Day 1 and Day 2 (p = 0.007, p < 0.001), respectively. Similarly, the 0.3% SH group exhibited a statistically significant higher (p < 0.001) rate of healing of the corneal epithelial defect over days 0 and 1 (4.94 ± 2.16 mm²/day) when compared to that of the 0.18% SH group (3.53 ± 1.66 mm²/day). CONCLUSION: With two commercial artificial tears, the corneal epithelial wound healing after pterygium surgery was faster in the 0.3% SH group than that of the 0.18% SH group. Superiority of 0.3% SH may be supported by the presence of epsilon-aminocaproic acid in this drug preparation. No significant adverse effects were exhibited during the short-term follow-up.

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