Determinants of Pterygium Occurrence and Recurrence in a Rural African Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 355
- 试验地点
- 1
- 主要终点
- None recurrence of pterygium
研究概览
简要总结
The aim of the study is to find out why pterygium occurs and recurs in a rural African population. Participants will be interviewed on personal and lifestyle information, family history of pterygium, environmental exposure and history of previous eye inflammation. They will undergo eye examination and photography. Those with pterygium will be operated on to remove pterygium and followed up to detect any recurrence and complications of surgery. The excised pterygium will be examined pathologically and genetically; participant's blood will also be examined genetically. Data will be analyzed for statistically significant differences in findings between pterygium and pterygium free participants.
The study hypothesis is that multiple factors are responsible for the occurrence and recurrence of pterygium in a rural african population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pterygium at least 1.5mm in extent
- •Both male and female
- •Age range 21-65 years
- •Consenting to participate in study
- •Unilateral and bilateral pterygium
- •All grades of pterygium
排除标准
- •Previous cataract, corneoscleral and glaucoma surgery or corneoscleral trauma and corneolimbal scars
- •Pseudopterygium or signs of malignancy on pterygium
- •Recurrent pterygium
- •Sufferers of collagen vascular disease, scleritis or diabetes -
研究组 & 干预措施
1
Pterygium free participants
2
Pterygium participants
干预措施: Pterygium excision followed by grafting (Procedure)
结局指标
主要结局
None recurrence of pterygium
时间窗: 6 months of follow up after operation
次要结局
- corneal scarring(6 months of follow up)
- tenon's granuloma(6 months of follow up)
- graft retraction(one month of follow up)
- Graft haematoma(one week of follow up)
- Graft hyperaemia(3 months of follow up)