Abstract
BackgroundThe purpose of this study was to evaluate the safety and effectiveness of the hyperdry amniotic membrane transplantation compared with conjunctival autografting for the treatment of primary pterygium.MethodsOne hundred and forty-one eyes from 130 patients with primary pterygium were treated with excision followed by hyperdry amniotic membrane or conjunctival autografting after random selection. Seventy-nine eyes from 71 patients received hyperdry amniotic membrane transplantation (HD-AM group), and 62 eyes from 59 patients received conjunctival autografting (CG group). Patients were followed up at one week and one, three, six, and 12 months post-surgery. Recurrence rate, postoperative complications, and final follow-up patient visits were prospectively evaluated.ResultsThe mean follow-up duration was 12.56 ± 4.35 months in the HD-AM group and 12.85 ± 3.90 months in the CG group. Recurrences were detected in four eyes (5.06%) in the HD-AM group and 13 eyes (20.97%) in the CG group. A statistically significant difference in frequency of recurrence between the two groups (P = 0.003) was observed. The cumulative non-recurrence rates at six and 12 months in all patients stratified by age and sex were not significantly different (P = 0.642 and P = 0.451, respectively, by log-rank test). Graft retraction and necrosis were not detected in the two groups during the follow-up period.ConclusionHyperdry amniotic membrane transplantation was effective in preventing pterygium recurrence when compared with conjunctival autografting and can be considered a preferable and safe grafting procedure for primary pterygium.Trial registrationCurrent Controlled Trials ISRCTN16900270, Retrospectively registered (Date of registration: 3 May 2018).
Highlights
The purpose of this study was to evaluate the safety and effectiveness of the hyperdry amniotic membrane transplantation compared with conjunctival autografting for the treatment of primary pterygium
HD-amniotic membrane (AM) has been exploited as a new ophthalmic tool for the management of many ocular surface diseases, including corneal perforations and bleb leaks [10]
Patients were randomized into the hyperdry amniotic membrane transplantation or conjunctival autografting groups (HD-AM and CG groups, respectively) for pterygium excision
Summary
The purpose of this study was to evaluate the safety and effectiveness of the hyperdry amniotic membrane transplantation compared with conjunctival autografting for the treatment of primary pterygium. Hyperdry (HD)-AM was developed as a new matrix material that is suitable for tissue engineering applications in the form of a surgical patch [7] It is a new type of AM that is expanded on a nitrocellulose filter paper with epithelial sheet facing upward, processed using consecutive far-infrared rays and microwaves (patented hyperdry method), and sterilized by cobalt-60 irradiation [8]. Thereafter, it was cut into all kinds of squares, vacuum packed, and stored safely at room temperature [9]. HD-AM has been exploited as a new ophthalmic tool for the management of many ocular surface diseases, including corneal perforations and bleb leaks [10]
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