Comparative Evaluation of Micropulse Laser in Treatment of Initial and Refractory Cases of Center-Involved Diabetic Macular Edema
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change of best-corrected visual acuity
研究概览
简要总结
This study aims to evaluate the effect of subthreshold 577 nm micropulse laser photocoagulation in the treatment of initial and refractory cases of Center-Involved Diabetic Macular Edema.
详细描述
Diabetic Retinopathy (DR) is a common and specific microvascular complication of diabetes that affects 17-54% of people with diabetes aged between 49 and 60 years.
Diabetic macular edema (DME) is one of the most common causes of visual loss in today's society. It affects about 10% of diabetic individuals and 29% of those who have had the condition for more than 20 years.
In micropulse mode, the laser emits short pulses, thereby reducing thermal energy in the target area.
This strategy has two properties: a shorter exposure time and a subvisible clinical endpoint, delivering energy by dividing the beam into a series of short pulses (100-300 µs). Every single pulse has an "on and off" duration (duty cycle (DC)), enabling tissues to cool down before the next pulse.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Both sexes.
- •Patients with type 1 or 2 diabetes mellitus (DM), best-corrected visual acuity (BCVA) of 20/400 or better, and center-involved DME [defined as a central macular thickness (CMT) of >250 but <700µm measured by spectral-domain optical coherence tomography].
- •Patients with any level of non-proliferative diabetic retinopathy or proliferative diabetic retinopathy with adequate panretinal photocoagulation (PRP) and no signs of disease activity determined by fluorescein angiography (FA).
排除标准
- •Monocular eyes.
- •Chronic renal failure or renal transplant because of diabetic nephropathy.
- •Glycated hemoglobin (HbA1c) of more than 10%.
- •Vitreomacular traction syndrome.
- •Epiretinal membrane.
- •PRP within 4months before the treatment.
- •Intraocular surgery within 6months, including cataract or vitreoretinal operation.
- •Rubeosis iridis.
- •Severe glaucoma.
- •High-risk proliferative diabetic retinopathy.
- •Poor dilation.
- •Increased foveal avascular zone.
- •Any condition that could interfere with optical coherence tomography (OCT) measurement or visual acuity.
结局指标
主要结局
Change of best-corrected visual acuity
时间窗: 6 months post-procedure
Change of best-corrected visual acuity will be recorded.
次要结局
- Change of central macular thickness(6 months post-procedure)
- Change of area thickness(6 months post-procedure)
- Change of macular volume(6 months post-procedure)
研究者
Hossam Abdelfattah Husein Hassan
Fellow of Ophthalmology, Sohag Teaching Hospital, Egypt.
The General Authority for Teaching Hospitals and Institutes