Comparative Study Of Surgical Outcomes Using Different Viscoelastic Agents In Topical Phacoemulsification Among Diabetic Patients With Cataracts At A Tertiary Care Centre
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Postoperative corneal endothelial cell loss associated with different viscoelastic agents
研究概览
简要总结
This is a prospective, comparative, open-label interventional study to evaluate surgical outcomes of different viscoelastic agents in topical phacoemulsification among diabetic patients with cataract at a tertiary care centre. A total of 174 patients (87 in each group) will be included. Group 1 will receive Sodium Hyaluronate Ophthalmic Solution (Hyloject) and Group 2 will receive Hypromellose Ophthalmic Solution USP (Hyprosol) during cataract surgery. The primary outcome is postoperative corneal endothelial cell loss. Secondary outcomes include visual recovery, intraocular pressure changes, and postoperative complications. The study duration will be 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with senile cataract and diagnosed diabetes mellitus.
- •2.Patients willing to give informed consent.
排除标准
- •1.Preoperative glaucoma or IOP more than 20 mmHg. 2.Intraoperative complications like manual dilatation of pupil, posterior capsular rent, sulcus IOL placement.
- •3.Presence of subluxation, pseudoexfoliation, or other associated ocular/corneal pathology.
- •4.Previous intraocular surgery in study eye.
结局指标
主要结局
Postoperative corneal endothelial cell loss associated with different viscoelastic agents
时间窗: Pre-Operative, Post-Operative Day 1, Day 15, and 1 Month
次要结局
- Visual Acuity (Both Uncorrected and Corrected Visual Acuity)(Pre-Operative, Post-Operative Day 1, Day 15, and 1 Month)
- Intraocular Pressure (IOP) Changes(Pre-Operative, Post-Operative Day 1, Day 15, and 1 Month)
- Postoperative Complications Related To Viscoelastic Agents(Post-Operative Day 1, Day 15, and 1 Month)
研究者
Dr Savsani Varnil Rajeshbhai
Datta Meghe Institute of Higher Education & Research