Department of Cornea and Refractive Surgery, Instituto de Oftalmología Fundación Conde de Valenciana IAP, Mexico City, Mexico.
Department of Oculoplastics, Instituto de Oftalmología Fundación Conde de Valenciana IAP, Mexico City, Mexico.
Br J Ophthalmol. 2023 Nov 22;107(12):1776-1781. doi: 10.1136/bjo-2021-320707.
The purpose of this double-masked, parallel randomised controlled trial was to compare the recurrence rate and other outcomes between conjunctival-limbal autograft (CLAu) and mini-simple limbal epithelial transplantation (mini-SLET) after excision of pterygium.
Eligibility criteria for participants was the presence of a primary nasal pterygium extending equally to or greater than two millimetres on the cornea on its horizontal axis from the nasal limbus. The participants were allocated into two groups (CLAu and mini-SLET) using simple randomisation with a table of random numbers. Participants and the outcome assessor were masked to the intervention. The study protocol is listed and available on https://clinicaltrials.gov (Identifier: NCT03363282).
A total of 61 eyes were enrolled in the study, 33 underwent CLAu (group 1) and 28 mini-SLET (group 2), all eyes were analysed in each group. At 2, 3, 6 and 12 months the CLAu group exhibited a recurrence of 0%, 6.1%, 8.1% and 8.1%, while the mini-SLET exhibited a recurrence of 0%, 17.9%, 50% and 53.5% (p<0.05). There were no intraoperative or postoperative complications in either of the two groups.
The findings of this study suggest that mini-SLET has a higher recurrence rate and provides no advantage over CLAu in the treatment of primary pterygium.
本双盲、平行随机对照试验的目的是比较翼状胬肉切除术后结膜-角膜缘自体移植(CLAu)和微型简单角膜缘上皮移植(mini-SLET)的复发率和其他结局。
参与者的入选标准为原发性鼻侧翼状胬肉,在其水平轴上从鼻侧角膜缘向角膜延伸相等或大于 2 毫米。参与者采用简单随机分组,使用随机数表进行分组。参与者和结局评估者对干预措施进行了盲法。研究方案列于并可在 https://clinicaltrials.gov 上获得(标识符:NCT03363282)。
共有 61 只眼纳入研究,33 只眼接受 CLAu(第 1 组),28 只眼接受 mini-SLET(第 2 组),每组均对所有眼进行了分析。在 2、3、6 和 12 个月时,CLAu 组的复发率分别为 0%、6.1%、8.1%和 8.1%,而 mini-SLET 组的复发率分别为 0%、17.9%、50%和 53.5%(p<0.05)。两组均无术中或术后并发症。
本研究结果表明,mini-SLET 的复发率较高,在治疗原发性翼状胬肉方面与 CLAu 相比没有优势。