CTRI/2024/03/064454尚未招募2 期
Single arm pilot clinical trial to evaluate the efficacy of Ayurvedic treatment on Diabetic Macular Edema - Nil
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- one
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patient who consent for study
- •Study eye having CI-DME as confirmed on OCT.
- •Patients with best corrected ETDRS visual acuity score of at least 79 (Snellen
- •equivalent of 20/25).
- •Patients who decline both intravitreous therapy and laser photocoagulation and
- •willing to take study group medication.
- •Patients with good glycemic control by diet control, lifestyle modifications or
- •systemic hypoglycemic drugs.
- •Only one eye of participant to be included. The eye with worse BCVA will be
- •included in the study. In case both eyes have equal best corrected visual acuity the
- •right eye will be considered for study.
- •Non-pregnant women.
排除标准
- •Patient with diabetic macular edema with proliferative diabetic retinopathy
- •Patients treated with focal/grid laser within 6 month, intravitreal Anti-VEGF injections within 3 month and intravitreal steroid within 6 months of study entry, history of
- •intraocular surgery within 90 days before study entry.
- •Patients with unstable medical status including blood pressure and glycemic control
- •Patients in poor glycemic control who recently initiated intensive insulin treatment (a
- •pump or multiple daily injections) or plan to do so in the next 6 months.
- •Macular edema is not considered to be due to a cause other than diabetic macular edema. An eye should not be considered eligible (i) if the macular edema is considered to be related to cataract extraction or (ii) clinical examination and/or OCT suggests that vitreoretinal interface disease (e.g. vitreo-retinal traction or epiretinal membrane) is the
- •primary cause of the macular edema.
- •Ocular condition (other than diabetes) that might affect macular edema or alter visual
- •acuity (e.g. vein occlusion, uveitis or other ocular inflammatory disease, neovascular
- •glaucoma, Irvine- Gass Syndrome). Glaucoma per se is not an exclusion.
- •An ocular condition is present such that, visual acuity would not improve from resolution of macular edema (e.g. foveal atrophy, pigmentary changes, dense sub-foveal
- •hard exudates, non- retinal condition).
- •Patients with a history of acute coronary event or stroke, renal failure, pregnancy or
- •Media clarity, pupillary dilation, and patient cooperation insufficient for adequate
- •fundus and OCT examination.
- •If patient decides to leave the trial to undergo intravitreous standard therapy.
- •Any adverse effect observed.
研究者
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