Randomized Clinical Trials to Compare the Healing Process of Idiopathic Macular Hole With Different Surgical Techniques
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Rate of Anatomic closure
研究概览
简要总结
To compare anatomic and functional results, and to evaluate postoperatively the healing process in 2 different techniques for the closure of the macular holes (MH)
详细描述
Patients with macular holes classified in stages 3 and 4 will be randomized into 2 groups. . In Group A, patients will undergo peeling with complete removal of the internal limiting membrane (ILM) and in the group B, the inverted ILM peeling technique will be performed. The 20% sulfur hexafluoride (SF6) gas will be used as a tamponade agent in all surgeries, and patients will be instructed to avoid the prone position for 5 days.
OCT images will be performed in the first 5 postoperative days and months 1, 3 and 6.
The primary outcome is anatomic closure of the MH closure in the month 6. The second outcomes are: mean best corrected visual acuity (BCVA) at month 6, mean change in the BCVA at month 6; integrity of the perifoveal external limiting membrane and ellipsoid zone on Optical Coherence Tomography (OCT); MH closure rate over time in days; functional improvement of microperimetry Statistical analysis will be performed with Student t-test and the p-value of ≤ 0.05 is considered significant.
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
- None
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
- •> Stage 3 and 4 macular holes with visual acuity between 20/30 and 20/800 according to the ETDRS chart.
排除标准
- •Macular holes secondary to ocular trauma, myopia or retinal detachment
- •Any previous treatment for the macular hole
- •Evidence on examination of any diabetic retinopathy
- •History or presence of wet or dry age macular degeneration (AMD)
- •Presence of epiretinal membrane or prior uveitis
- •Any ocular surgery within 3 months before baseline
- •Intra or periocular infection
研究组 & 干预措施
Group A: Conventional ILM peeling
peeling with complete removal of the internal limiting membrane (ILM)
干预措施: Conventional ILM Peeling (Procedure)
GroupB: Inverted ILM Peeling
the inverted ILM peeling technique, in which the ILM is left in the edge of the macular hole and the free area is inverted over the macular hole before fluid-air exchange
干预措施: Inverted ILM Peeling (Procedure)
结局指标
主要结局
Rate of Anatomic closure
时间窗: Month 6 post operative
Rate of anatomic macular hole closure in the OCT at month 6
次要结局
- BCVA mean(Month 6 post operative)
- BCVA change(Screening and Month 6 post operative)
- Integrity Membrane measured in microns (μm) by OCT(Month 6 post operative)
研究者
Mauricio Maia
Professor of Ophthalmology Dept
Federal University of São Paulo