CTRI/2023/03/050271尚未招募不适用
To study the role of suprachoroidal dexamethasone injection in patients with Diabetic Retinopathy
GSVM MEDICAL COLLEGE1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2023年2月3日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- IMPROVEMENT IN VISUAL ACUITY
研究概览
简要总结
TO DETERMINE THE ROLE OF SUPRACHOROIDAL DEXAMETHASONE INJECTION IN PATIENTS WITH DIABETIC RETINOPATHY.
WE WILL RECRUIT PATIENTS DIAGNOSED WITH DIABETES MELLITUS AND GRADE THEM INTO VARIOUS STAGES OF DIABETIC RETINOPATHY AFTER PERFORMING STANDARDISED INVESTIGATIONS.WE WILL ENROLL PARTICIPANTS AS PER OUR INCLUSION AND EXCLUSION CRITERIA. AFTER TAKING PROPER CONSENT AND TAKING APPROPRIATE ASEPTIC PRECAUTIONS IN OUR OT WE WILL INJECT 0.1ML DEXAMETHASONE VIA SUPRACHOROIDAL ROUTE UNDER TOPICAL ANESTHESIA.THEN WE WILL FOLLOW UP PATIENTS REGULARLY TO LOOK FOR THE CHANGES IN DISEASE STAGE (IMPROVEMENT/HALT/PROGRESSION) ALONGWITH POSSIBLE ADVERSE EFFECTS THAT WE CAN ANTICIPATE IN OUR INTERVENTION.
研究设计
- 研究类型
- Interventional
- 分配方式
- Adaptive randomization, such as minimization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •PATIENTS DIAGNOSED WITH TYPE 2 DIABETES MELLITUS WITH MILD AND MODERATE DIABETIC RETINOPATHY.
排除标准
- •PATIENTS NOT WILLING TO PARTICIPATE OR READY FOR FOLLOW UP.
- •PATIENTS HAVING SEVERE DIABETIC RETINOPATHY,PROLIFERATIVE DIABETIC RETINOPATHY AND DIABETIC MACULAR EDEMA.
- •PATIENTS WITH UNCONTROLLED DIABETES.
- •PATIENTS WITH ANY OCULAR INFECTION,RAISED INTRAOCULAR PRESSURE,ANY CORNEAL PATHOLOGY,THINNED SCLERA,SCLERITIS,STAPHYLOMA OR ANY OTHER ANTERIOR SEGMENT PATHOLOGY EXCEPT PSEUDOPHAKIC PATIENTS.
- •PATIENTS DIAGNOSED OF ANY OTHER RETINAL OR VITREOUS PATHOLOGIES EXCEPT DIABETIC RETINOPATHY.
结局指标
主要结局
IMPROVEMENT IN VISUAL ACUITY
时间窗: 3-6 MONTHS
次要结局
- RAISED INTRAOCULAR PRESSURE(1-5 DAYS)
- CHOROIDAL/RETINAL DETACHMENT(1 DAY)
- CATARCT(6 MONTHS- 1 YEAR)
- DECREASE IN VISUAL ACUITY(1 DAY- 1YEAR)
- VITRITIS/ ENDOPHTHALMITIS(15 DAYS)
研究者
研究点 (1)
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