Evaluation of Conjunctival Autografting Augmented With Mitomycin-C Application Versus Ologen Implantation in Surgical Treatment of Recurrent Pterygium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 主要终点
- 32 eyes with Topical application of Mitomycin C in concentration of (0.2 mg/mL).
研究概览
简要总结
Ologen implantation with conjunctival autografting shows promising results in surgical management of recurrent pterygium comparable to MMC application with conjunctival autografting with mild non vision threatening postoperative complications.
详细描述
Patients were randomly enrolled into two groups. Group A included 32 eyes of 32 patients who underwent conjunctival autografting augmented with topical application of Mitomycin C (0.2 mg/mL). Group B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation.
All patients had a recurrent nasal pterygium after one surgical session for removal of the primary one. Any patient with primary nasal pterygium, or patients with recurrent pterygium who had more than one session for surgical removal were excluded. As well, patients with cicatrizing conjunctival disease or previous conjunctival surgery were excluded from the study.
A comprehensive ophthalmic examination, including best-corrected visual acuity testing, slit-lamp examination, Goldmann applanation tonometry, fundus examination, and examination of ocular motility, was carried out for all patients. According to their corneal extent, pterygia were classified into 3 grades:
Grade 1: Fibrovascular proliferations extend up to one quarter of the corneal diameter.
Grade 2: Fibrovascular proliferations extend up to the center of the cornea. Grade 3: Fibrovascular proliferations extend beyond the visual axis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •recurrent nasal pterygium after one surgical session for removal of the primary one
排除标准
- •primary nasal pterygium,
- •recurrent pterygium with more than one session for surgical removal
结局指标
主要结局
32 eyes with Topical application of Mitomycin C in concentration of (0.2 mg/mL).
时间窗: "through study completion, an average of 1 year".
As for group A, 0.2 mg/mL MMC was prepared by reconstituting 2 mg vial of Mitomycin with 10 mL sterile water for injection. When using Mitomycin 10 mg vial, the same concentration was achieved by reconstituting the 10 mg vial 10 mL sterile water for injection. Then 1 ml of the prepared solution was diluted with 4 ml of saline to achieve 0.2 mg/mL (0.02% solution).
31 eyes with ologen implantation(6 mm in diameter and 2 mm thick.) was used for each patient.
时间窗: "through study completion, an average of 1 year".
In group B; Ologen was applied under the graft tissue once it is secured in place (half the vial is used for every patient)
次要结局
未报告次要终点
研究者
Amin Faisal Ellakwa
clinical professor
Menoufia University