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临床试验/CTRI/2025/10/096620
CTRI/2025/10/096620尚未招募4 期

Posterior Subtenon Triamcinolone Acetonide and Topical Corticosteroids for Postoperative Inflammation Control Following Small Incision Cataract Surgery: A Randomized Controlled Study

Sri Devaraj Urs Medical College1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2025年11月10日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
66
试验地点
1
主要终点
Degree of postoperative anterior chamber inflammation (cells and flare) on POD 1, 7, and 30

研究概览

简要总结

This is a prospective interventional randomized parallel group active controlled clinical trial conducted in the Department of Ophthalmology RL Jalappa Hospital and Research Centre Sri Devaraj Urs Medical College Kolar. The study aims to compare the efficacy and safety of posterior subtenon triamcinolone acetonide versus topical prednisolone one percent eye drops for controlling postoperative inflammation following uncomplicated small incision cataract surgery.

A total of 66 patients aged 40 years and above with operable age related cataract will be recruited after written informed consent and randomized equally into two groups. Group A will receive a single intraoperative posterior subtenon injection of triamcinolone acetonide 40 mg per mL 0.5 mL. Group B will receive standard postoperative topical prednisolone one percent eye drops in tapering doses over four weeks.

Randomization will be done using computer generated block randomization and allocation will be concealed using sequentially numbered sealed opaque envelopes. All surgeries will be performed by a single experienced surgeon under peribulbar anesthesia. Postoperative evaluation will be conducted by a blinded observer on postoperative days 1 7 and 30. Parameters assessed include anterior chamber inflammation cells and flare intraocular pressure visual acuity and adverse events.

The primary objective is to compare the degree of postoperative anterior chamber inflammation between the two groups. Secondary objectives include assessing intraocular pressure changes visual acuity outcomes patient compliance and incidence of steroid related complications. Statistical analysis will include descriptive statistics independent t tests Chi square and Fisher exact tests and repeated measures ANOVA to evaluate outcomes over time. Sample size is 33 per group to achieve 80 percent power at 95 percent confidence to detect a clinically significant difference in postoperative inflammation.

This investigator initiated academic study aims to determine whether a single posterior subtenon injection can provide comparable or superior anti inflammatory control to standard topical steroids potentially improving patient compliance and postoperative outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
40.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Age more than 40 years Diagnosed with operable age-related cataract Undergoing uncomplicated SICS with posterior chamber IOL implantation.

排除标准

  • Pre-existing glaucoma or ocular hypertension History of uveitis or intraocular inflammation Complicated cataract like traumatic, subluxated, or mature cataract with phacolytic uveitis) Intraoperative complications like posterior capsular rupture, vitreous loss Systemic conditions affecting ocular inflammation like uncontrolled diabetes mellitus, autoimmune disorders Known allergy to corticosteroids Presence of corneal opacity or dystrophy affecting examination or IOP measurement.

结局指标

主要结局

Degree of postoperative anterior chamber inflammation (cells and flare) on POD 1, 7, and 30

时间窗: Postoperative day 1, 7, and 30

次要结局

  • Change in IOP from baseline

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Rashmi G

Sri Devaraj Urs Medical College

研究点 (1)

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