Effect of Topical Losartan in Patients with Corneal Opacity: A Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Effect of intervention on corneal opacity and scarring in terms of
研究概览
简要总结
This is a Pilot study to see the effect of Topical Losartan 0.08% eye drops in patients with corneal opacities compared to placebo.
Both patients and investigator will be blinded and patients will be randomly receiving either Topical Losartan 0.08% or the placebo (E/D CMC 0.5%) via pharmacy controlled randomization.
Patients will be asked to administer the eye drops 6 times a day and will be followed up at 2 weeks, 4 weeks, 12 weeks, 16 weeks when the effect of intervention will be compared based on area of opacity as seen on slit lamp biomicroscopy, depth of scarring as seen on AS-OCT, scheimpflug-based Corneal Densitometry values, improvement in visual acuity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Consenting adults (age above 18 years) with corneal opacity due to Keratitis, Ocular Trauma, Trachoma.
排除标准
- •1.Patients having active ulcer.
- •2.Patients having active inflammation.
- •3.Patients having active infection.
- •5.Patients on systemic medication.
结局指标
主要结局
Effect of intervention on corneal opacity and scarring in terms of
时间窗: Baseline, 2 weeks, 4 weeks, 12 weeks and 16 weeks.
1.Area of opacity as seen on slit lamp biomicroscopy.
时间窗: Baseline, 2 weeks, 4 weeks, 12 weeks and 16 weeks.
2.Depth of scarring as seen on AS-OCT.
时间窗: Baseline, 2 weeks, 4 weeks, 12 weeks and 16 weeks.
3.Scheimpflug-based Corneal Densitometry values.
时间窗: Baseline, 2 weeks, 4 weeks, 12 weeks and 16 weeks.
4.Improvement in visual acuity.
时间窗: Baseline, 2 weeks, 4 weeks, 12 weeks and 16 weeks.
次要结局
未报告次要终点
研究者
Lokesh Paras Mandlecha
DR RP CENTER OF OPHTHALMIC SCIENCE AIIMS