A randomized, parallel group, open label, Comparative study of laser photocoagulation with and without intravitreal triamcinolone acetonide in clinically significant macular edema (CSME) in diabetic retinopathy.

Govt medical college and Sir Takhatsinhji General Hospital Bhavnagar0 个研究点目标入组 40 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1)Diagnosis of diabetes mellitus ( type or type 2).
•2)Age >= 18 years.
•3)Able and willing to provide informed consent.
•4) Definite retinal thicking due to diabetic macular edema based on clinical examination involving the centre of the macula.
•5) Media clarity, papillary dilatation, and patient cooperation sufficient
•For adequate fundus photographs.
•6) IOP < 25 mmHg

•1)History of chronic renal failure requiring dialysis or kidney transplant.
•2)Known allergy to any corticosteroid or any component of the delivery vehicle.
•3)History of systemic (e.g. oral, IV, IM, epidural, bursal) corticosteroids within 4 ) months prior to randomization or topical, rectal or inhaled corticosteroids in current use more than 2 times per week.
•5)Proliferative diabetic retinopathy.
•6)Aphakia.
•7)Intraocular pressure >= 25 mmHg.
•8)History of open angle glaucoma.
•9)History of steroid-induced intraocular pressure elevation that required IOP lowering agents.
•10)History of prior treatment with intravitreal corticosteroids within 6 months prior to randomization.
•11)History of focal/grid macular photocoagulation within 15 weeks (3.5 months) prior to randomization.
•12)History of panretinal scatter photocoagulation (PRP) within prior 4 months or anticipated within the next 6 months following randomization.
•13)History of major ocular surgery ( including cataract extraction, scleral buckle, any intraocular surgery etc.) within prior 6 months or anticipated within the next 6 months following randomization.
•14)History of prior herpetic ocular infection.
•15)An ocular condition is present such that visual acuity would not improve from resolution of macular edema (e.g. foveal atrophy, pigmentary changes, nonretinal conditions).

发起方

Govt medical college and Sir Takhatsinhji General Hospital Bhavnagar