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临床试验/CTRI/2024/07/070700
CTRI/2024/07/070700尚未招募2/3 期

Comparison of the efficacy and safety of subthreshold micropulse laser Vs Conventional modified grid laser therapy for Non-centre involving Diabetic macular edema

Aravind Eye Hospital Chennai1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年7月26日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
34
试验地点
1
主要终点
Comparing Change in macular volume and thickness between 2 groups

研究概览

简要总结

Diabetic macular edema (DME) is thickening of the retina at the macular zone, which can affect the fovea and cause central loss of vision in patients with diabetes mellitus.

DME is one of the leading causes of preventable blindness and visual acuity in diabetic population globally

The current gold standard treatment of non centre involving DMEis modified grid laser photocoagulation

However, it had various potential side effects like enlargement of laser scars, scotomas, fibrosis, hemorrhage, accidental foveal injury, choroidal neovascular membrane (CNVM) formation.

In the last decade, Subthreshold micropulse laser (SMPL) treatment has been intensively used for selected retinal diseases

Subthreshold micropulse laser (SMPL) uses a series of short pulses rather than a short continuous delivery producing sublethal thermal effects, thereby stimulating retinal pigment epithelium (RPE).

SMPL is a non destructive alternative treatment for DME and hence also has advantage of safely allowing multiple treatment sessions as needed.

 Major objective:

To compare the efficacy and safety of 577 nm subthreshold micropulse laser (SMPL) in one arm versus 532 nm modified grid laser in the other arm

研究设计

研究类型
Interventional

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Non-centre involving DME – defined as SRF or IRF outside the central 1 mm of fovea
  • Treatment naïve for DME
  • ≥ 18years age.

排除标准

  • Previous Intravitreal injections
  • Proliferative diabetic retinopathy requiring concurrent PRP.
  • (Stable PDR patients post PRP are eligible for inclusion)
  • Concurrent other ocular comorbidities like glaucoma
  • Patients with Visually significant cataract
  • Uncontrolled hypertension, uncontrolled diabetes (glycosylated hemoglobin [HbA1c] >12%), or recent (within 3 months) cerebrovascular accident (CVA), or myocardial infarction (MI).
  • One Eyed patients.

结局指标

主要结局

Comparing Change in macular volume and thickness between 2 groups

时间窗: 6 weeks, 12 weeks

次要结局

  • Comparing Change in BCVA between 2 groups(Comparing Change in Autofluorescence and Visual Field Index HFA 24-2 between 2 groups)

研究者

发起方
Aravind Eye Hospital Chennai
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Anisha Agrawal

General Ophthalmology, Aravind Eye Hospital, Chennai

研究点 (1)

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