Macular Micro Vascular Changes Following Macular Hole Repair : Optical Coherence Tomography Angiography Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- visual acuity
研究概览
简要总结
The goal of this prospective interventional study is to to compare the micro vascular and structural changes between surgery with and without ILM flap to repair macular hole.
The main questions it aims to answer are:
- What are the macular micro vascular and structural changes pre and post repair of idiopathic full thickness macular hole and what is the correlation between these changes and visual recovery.
- Is there are any prognostic values of the micro vascular status of the macula could be assessed preoperatively.
- What are the differences regarding these micro vascular and structural changes between repair with and without ILM flap.
Participants will be:
- Subjected to pars plana vitrectomy to repair macular hole.
- Examined by optical coherence tomography angiography pre and post operative
Researchers will compare:
Group A: eyes treated without ILM flap Group B : eyes treated by ILM flap to see if there are differences regarding the micro vascular and structural changes in the macular area.
详细描述
This study will include 28 eyes with idiopathic full thickness macular hole; they will be divided into two groups:
Group A: 14 eyes will be treated without ILM flap Group B : 14 eyes will be treated by ILM flap
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Sample size: 28 eyes. (based on ELM recovery rate in ILM flap 70% versus 21.4% with inverted flap (Iwasaki et al., 2019), and at power of study 80% and confidence level 95%, sample size is calculated using openEpi software to be 14 eyes in each group
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Study setting: Ophthalmology Department, Fayoum University and the Research Institute of Ophthalmology
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Data Collection :
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History :
- Demographic data ( age , gender )
- General medical history ( DM, HTN )
- Symptom duration
- Previous ocular history
- Clinical examination:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic full thickness Macular hole without retinal detachment
排除标准
- •Previous pars plana vitrectomy
- •High myopia with axial length ≥ 26 mm.
- •Uncertain symptom duration or ≥ 6 month .
- •History of same eye trauma
- •Poor image quality.
- •Patients with diabetic retinopathy or other retinal diseases, e.g. ischemic, inflammatory.
- •Any patient with significant cataract which needs combined phaco-vitrectomy.
结局指标
主要结局
visual acuity
时间窗: It will be measured preoperative and at 1 and 6 months post-operative
Best corrected visual acuity measurement using Snellen chart with conversion to log. MAR notation for statistical analysis
Fovea avascular zone FAZ
时间窗: It will be measured preoperative and at 1 and 6 months post-operative
Optical coherence tomography angiography used to measure FAZ area in mm2 (mm square)
次要结局
- central retinal thickness(It will be measured preoperative and at 1 and 6 months post-operative)