The effect of sustained release long acting intravitreal dexamethasone implant in patients with non-proliferative diabetic retinopathy undergoing cataract surgery

Allergan India0 个研究点目标入组 151 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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•INCLUSION CRITERIA
•The patients of Type 2 Diabetes Mellitus fulfilling the following inclusion criteria shall be enrolled in the study:
•1 Presence of visually significant cataract requiring surgery (any grade)
•2 Patients with Non-proliferative Diabetic Retinopathy (NPDR) with/without clinically significant macular edema (CSME)
•The patients of either sex (age 30 years or more) would be included for the study.

•EXCLUSION CRITERIA
•The following would be the exclusion criteria:
•1 Presence of proliferative diabetic retinopathy
•2 Patients with history of ocular hypertension or glaucoma
•3Presence of associated conditions that may exacerbate macular edema, i.e. uveitis, retinal vein occlusions, neovascular glaucoma
•4History of use of any intravitreal / periocular agents including but not limited to bevacizumab, ranibizumab or steroids (systemic or local) in the past three months.
•5History of use of drugs such as prostaglandin analogues, adrenaline or nicotinic acid
•6History of any intraocular surgery or laser photocoagulation in the past three months.
•7Any history of prior pars plana vitrectomy
•8Patients with post-operative media haze or pupillary non-dilation that does not allow good fundus photography, FFA and OCT.
•9Patients who develop any intraoperative complication including posterior capsular rent, vitreous loss, zonular dehiscence, etc shall be excluded from the study in both the groups.

发起方

Allergan India