A prospective trial to assess results of trabeculectomy by using ologen as continuum from sub-scleral space to sub-conjunctival space
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
- Percentage of subjects having IOP of less than 20 mm Hg without or with reduced medication after 3months of surgery.
研究概览
简要总结
Glaucome is the leading cause of blindness in India. Trabeculectomy is the only permanent solution to this problem. In the past anti-metabolites and Ologen have been used to enhance the success of trabeculectomy. But till now Ologen is placed over the scleral flap. This placement does not help in preventing fifbosis of scleral tunnel. In the present study patients suffering from glaucoma satisfying inclusion criteria, will be operated for trabeculectomy. Ologen will be used as continuum from sub-scleral space to sub-conjunctival space. Reduction in IOP to less than 20mm of Hg with no or reduced medication will be qualified as success. Any adverse event will be recorded.
Results
Average preop medication used was 2.9, which was reduced to 0.05 post intervention.
Average preop IOP was 30mm of Hg on treatment which reduced to 14mm of Hg.
Two patients had hypotony in post op period which resolved without any intervention.
One patient had spontaneous migration of ologen out from ostium into sub-tenon space without any adverse effect.
Conclusion
Using Ologen in continuum from anterior chamber to sub-tenon space is an effective and safe technique for improving results of trabeculectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 10.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Patients with IOP not controlled on medication b) Patients willing to undergo trab as an alternative to life-long medication c) Patients not tolerating the anti-glaucoma medication.
排除标准
- •a) Any co-morbidity which contra-indicates surgery b) Patients having neo-vascular glaucoma.
结局指标
主要结局
Percentage of subjects having IOP of less than 20 mm Hg without or with reduced medication after 3months of surgery.
时间窗: Percentage of subjects having IOP of less than 20 mm Hg without or with reduced medication after 3months of surgery.
次要结局
- Adverse event(Day 1,3, 10, 30, 90)