Evaluation of Conjunctival Rotational Flap Compared to Conjunctival Autograft After Surgical Removal of Primary Pterygium: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 342
- 主要终点
- Pterygium Recurrence Rate
研究概览
简要总结
This study compares two surgical techniques for preventing the regrowth of a pterygium, a non-cancerous growth on the eye. After surgically removing the pterygium, surgeons will cover the area with either a flap of nearby tissue that is rotated into place (Rotational Flap) or with a free graft of tissue taken from under the upper eyelid (Autograft). The main goal is to see which method is better at preventing the pterygium from growing back over a 6-month period. A total of 342 patients with a primary pterygium will be randomly assigned to one of the two surgical groups.
详细描述
This is a single-center, prospective, randomized controlled trial to be conducted at the Department of Ophthalmology, Saidu Group of Teaching Hospital, Swat. The study aims to compare the efficacy of the Conjunctival Rotational Flap versus the Conjunctival Autograft in reducing recurrence rates following primary pterygium excision. Adult patients aged 18-60 with primary pterygium will be enrolled. Participants will be randomly allocated into two groups: Group A (Conjunctival Rotational Flap) and Group B (Conjunctival Autograft). The primary outcome measure is the absence of clinical recurrence, defined as fibrovascular tissue crossing ≥ 1 mm onto the cornea, assessed at the 6-month postoperative follow-up visit via slit-lamp examination. Secondary outcomes may include operative time and postoperative complications. Data will be analyzed using SPSS version 23, with a p-value of ≤ 0.05 considered statistically significant.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Age 18-60
- •Either gender
- •Primary pterygium
排除标准
- •• Collagen vascular disease
- •Autoimmune disorders
- •Pregnancy
- •Ocular surface infection
- •Previous limbal surgery
- •Recurrent or pseudo-pterygium
- •Ocular trauma
- •Corneal opacity/degeneration'
结局指标
主要结局
Pterygium Recurrence Rate
时间窗: 6 months postoperatively
Absence of clinical recurrence, defined as a quiet ocular surface with no fibrovascular regrowth ≥ 1 mm onto the cornea, as measured by slit-lamp examination.
次要结局
未报告次要终点
研究者
Faiz ur rahman
Postgraduate Resident, Department of Operative Dentistry
College of Physicians and Surgeons Pakistan