Comparative Evaluation of Inflammatory and Visual Outcomes in Diabetic and Non-Diabetic Patients Undergoing Cataract Surgery: Intraoperative Subconjunctival Steroid Depot versus Conventional Topical Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 768
- 试验地点
- 1
研究概览
简要总结
This study aims to compare two methods of controlling postoperative inflammation following cataract surgery in diabetic and non-diabetic patients. Effective management of inflammation is crucial for optimal visual recovery, especially in diabetic patients who are at higher risk of exaggerated inflammatory responses and complications such as cystoid macular edema.
Patients undergoing cataract surgery in this observational study will receive treatment according to standard clinical practice. One group receives a single intraoperative subconjunctival steroid depot injection, while the other receives conventional postoperative eye drops (steroid and NSAIDs). Both groups receive standard antibiotic eye drops to prevent infection.
The primary outcomes include control of anterior chamber inflammation (measured by cells and flare grading) and visual acuity recovery. Secondary outcomes include intraocular pressure changes, incidence of postoperative cystoid macular edema, etc. Assessments will be conducted on postoperative Day 1, Day 21, and Day 90.
Patients receiving the subconjunctival depot are expected to have non-inferior control of inflammation and visual outcomes compared to conventional topical therapy. This study will provide evidence on whether a single depot injection can be as effective as multiple daily eye drops, potentially reducing patient burden and improving compliance, particularly in diabetic patients with higher postoperative risk.
By comparing outcomes in both diabetic and non-diabetic patients, this study will help guide clinical decision-making and optimize postoperative care in routine cataract surgery.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Age 40 years to 99 years Patients undergoing uncomplicated phacoemulsification with IOL Implantation Group 1: Known Type 2 Diabetes patients without Diabetic retinopathy, or with mild diabetic retinopathy Group 2: Non-diabetic patients.
排除标准
- •History of uveitis, glaucoma, or ocular hypertension Intraoperative complications Combined ocular surgeries Use of systemic steroids or immunosuppressants Allergy to corticosteroids or study medications Moderate, Severe NPDR or PDR, macular edema.
研究者
Dr Yuvarani
Aravind Eye Hospital
