Protective Effect of Biodegradable Collagen Implant (Ologen) in Scleral Thinning After Strabismus Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Scleral thinning assessed with slit photography
研究概览
简要总结
This study is to investigate protective effect of biodegradable collagen implant in scleral showing after lateral rectus recession in patients with exotropia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with intermittent exotropia or constant exotropia
- •Alternate prism cover test showed 20 prism diopters or more than 20 prism diopters exotropia
- •Subjects who want to do strabismus surgery
排除标准
- •Subject who had previous strabismus surgery or other ocular surgery history
- •Thyroid eye disease or other connective tissue disease
- •Significant bleeding or scleral perforation during operation
- •Subjects who need to do medial rectus resection, not lateral rectus recession
- •Subjects who had a plan to do other intra or extraocular surgery within 3 months
研究组 & 干预措施
Biodegradable collagen implant
Both eyes are needed to correct strabismus. One eye is randomly selected for the placement of biodegradable collagen implant.
干预措施: lateral rectus recession with biodegradable collagen implant (Device)
Without biodegradable collagen implant
Strabismus surgery is done without placing of biodegradable collagen implant in the other eye.
干预措施: Lateral rectus recession without biodegradable collagen implantation (Procedure)
结局指标
主要结局
Scleral thinning assessed with slit photography
时间窗: Postoperative 3 months
Scleral thinning at the area, where lateral rectus was originally inserted, was assessed with slit photography. Scleral thinning score was calculated from the Lab color model.
次要结局
- Foreign body sensation assessed by questionnaire(Postoperative 1 week)
- Tearing assessed by questionnaire(Postoperative 1 week)
- Ocular discharge assessed by questionnaire(Postoperative 1 week)
- Collagen implant protrusion assessed by questionnaire(Postoperative 1 week)