The Use of Amniotic Membrane or Inverted Internal Limiting Membrane Flap for Large or Refractory Macular Holes: a Prospective, Comparative Study Using Microperimetry
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 23
- 试验地点
- 4
- 主要终点
- The retinal sensitivity
研究概览
简要总结
Prospective, randomized, unmasked interventional study. To evaluate anatomical and functional results through microperimetry in cases of refractory or large macular holes (MH), using amniotic membrane (AM) or internal limiting membrane ( ILM ).
详细描述
This study will evaluate functional outcomes through microperimetry in patients undergoing macular hole surgery. It will focus on patients with macular holes ≥600 microns, as well as those with holes refractory to conventional surgical treatment. The study will assess the use of amniotic membrane or internal limiting membrane (ILM) as adjuncts in the macular hole closure process.
The gold-standard treatment for idiopathic macular holes is pars plana vitrectomy (PPV), which involves removal of the posterior hyaloid (when adhered) and the ILM using a vital dye, followed by placement of buffering gas (C3F8 or SF6) at a non-expandable concentration. However, approximately 44% of large macular holes remain unclosed after conventional surgery.
To improve closure rates in such cases, new techniques have been introduced, including the inverted ILM flap technique and the free ILM flap technique. While studies demonstrate the effectiveness of these techniques, they show no significant improvement in visual function.
The amniotic membrane (AM) has recently been explored as an adjunct for macular hole closure and as a substrate for cell growth and visual acuity improvement. Amniotic membranes are believed to promote epithelialization and possess anti-fibrotic, anti-inflammatory, anti-angiogenic, and antimicrobial properties.
In this study, eligible patients will be randomized into two groups:
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
- •Patients with a macula hole that falls into the two categories below:
- •Patients with idiopathic macular hole (with no history of secondary macular hole) ≥ 600 microns (measured using optical coherence tomography)
- •Patients with an idiopathic macular hole submitted to conventional treatment without closing it (of any size).
- •History of the disease less than 18 months
- •Aged over 18 years old
- •Visual acuity less than 20/32
排除标准
- •History of any previous macular disease other than idiopathic macular hole
- •Macular hole of other causes (secondary)
- •Patients with diabetic retinopathy or other retinal vascular diseases
- •Eyes subjected to intravitreal injection of any medication
- •Visual acuity <20/400 of any retinal cause in the contralateral eye or absence of the globe *Aged under 50 years old
- •Cataract and anti-glaucoma surgery less than 3 months before the study
- •Glaucoma with optic nerve excavation > 0.7 in the studied eye
- •Intraocular pressure > 24 mmHg with the use of maximum medication in the studied eye
- •History of vitreoretinal surgery for a condition other than the idiopathic macular hole (retinal detachment, vitreous hemorrhage)
- •History of retinal detachment of any etiology
- •A patient who manifests himself not being able to perform the head position in the postoperative period
- •A patient with active anterior or posterior uveitis
结局指标
主要结局
The retinal sensitivity
时间窗: through study completion, an average of 1 year
measured by the microperimetry
The fixation stability
时间窗: through study completion, an average of 1 year
measured by the microperimetry
次要结局
- the macula hole closure rate(through study completion, an average of 1 year)
研究者
Anna Carolina Carvalho Araujo
Ophthalmologist , MD
Hospital Oftalmologico de Sorocaba