CTRI/2024/07/071151招募中不适用
Evaluation of effect of preoperative topical steroids on conjunctival histopathology in glaucoma surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Conjunctival cellular profile (mean no. of macrophages and other cells)
研究概览
简要总结
This is a randomised controlled trial to determine effect of preoperative topical low dose steroids on conjunctival histopathology markers for macrophages and other cells. The secondary outcomes measure the effect of preoperative topical low dose steroids on outcome of glaucoma surgery with respect to bleb morphology (clinical and ASOCT) and IOP at 4 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult primary glaucoma cases requiring trabeculectomy Patient on 3 or more different classes of topical antiglaucoma medications for a minimum of 3 months duration.
排除标准
- •Prior incisional surgery involving conjunctiva Dry eyes requiring more than or equal to two lubricant drops per day, prior herpetic keratitis Concurrent non-ophthalmic steroid use Known steroid responder.
结局指标
主要结局
Conjunctival cellular profile (mean no. of macrophages and other cells)
时间窗: 1 week, 1 month, 4 months
次要结局
- Bleb morphology by slit lamp examination (IBAGS)(1 week, 1 month, 4 months)
- Bleb function by IOP control(1 week, 1 month, 4 months)
- ASOCT (Anterior Segment Optical Coherence Tomography) for bleb morphology(1 week, 1 month, 4 months)
研究者
Dr Mehak Gupta
Maulana Azad Medical College
研究点 (1)
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