PEELED INTERNAL LIMITING MEMBRANE REPOSITION FOR IDIOPATHIC MACULAR HOLES: A Single-centre, Randomized, Prospective Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The change in the best corrected visual acuity (BCVA) from baseline to 6 months postoperatively
研究概览
简要总结
Macular hiatus (MH) refers to a tissue defect in the photoreceptor cell layer of the inner boundary membrane of the optic disc in the macular region. Among them, idiopathic macular hiatus (IMH) is more common in people over 60 years old and is a common eye disease. With the aging of society, the number of patients increases, and it severely damages the patients' vision and life quality. Previously, the conventional surgical approach for treating MH was vitrectomy combined with inner limiting membrane (ILM) peeling. Although the closure rate of MH is high, many damages to the morphology and function of the ILM peeled area have been found. Our team firstly report a novel technique of peeled ILM reposition. Compared to traditional ILM peeling, the novel technique peeled ILM reposition maintains the integrity of internal retina by "pull" back the ILM flap. The previous pilot clinical study suggests that the novel technique peeled ILM reposition surgical intervention can achieve better morphology and functional prognosis. However, there is currently a lack of larger sample size prospective randomized controlled studies to further clarify the clinical efficacy of this new surgical technique in treating IMH. This study aims to conduct a single center, prospective, and randomized controlled study, combined with previous work, to analyze the efficacy of this novel technique peeled ILM peeling in the treatment of IMH. We hypothesize that this novel technique can achieved better morphological and functional prognosis compared to traditional ILM peeling.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients are diagnosed as MH with a diameter ≤ 600 µm by optical coherence tomography.
- •Age ranges from 50 to 80 years.
- •Do not participate in other clinical studies.
- •Agree to sign an informed consent form with good compliance.
排除标准
- •Traumatic macular hole.
- •Combined with serious epiretinal membrane.
- •Combined with diabetic retinopathy, hypertensive retinopathy.
- •Combined with other ocular diseases, such as keratitis,uveitis,retinal vasculitis.
- •Spherical equivalent ≥ -6.0 diopters or axial length ≥ 26 mm.
- •History of intraocular surgery.
- •Presence of staphyloma.
- •Other ocular diseases that influence macular microstructure or visual function.
结局指标
主要结局
The change in the best corrected visual acuity (BCVA) from baseline to 6 months postoperatively
时间窗: Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,
The change of BCVA from baseline to 6-month postoperatively
次要结局
- The MH closure rate(1-month postoperatively)
- The range of inner retinal dimpling(1-month postoperatively, 3-month postoperatively, 6-month postoperatively,)
- mfERG P1 wave density amplitudes(Pre-operatively, 3-month postoperatively, 6-month postoperatively,)
- NEI-VFQ-25 questionnaire scores(Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,)
- The fixation stability and sensitivity threshold(Pre-operatively, 3-month postoperatively, 6-month postoperatively,)
- M-score values(Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,)
- Postoperative retinal thickness(Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,)
