Comparison of the efficacy and safety of subthreshold micropulse laser Vs Conventional modified grid laser therapy for Non-centre involving Diabetic macular edema
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
Dr Anisha Agrawal
General Ophthalmology, Aravind Eye Hospital, Chennai
