A Randomised Clinical Trial of Prognostic Factors and Surgical Methods for the Treatment of Idiopathic Macular Holes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Visual Acuity (ETDRS Letters)
研究概览
简要总结
The project is a randomized clinical trial with a follow up time of 12 months comparing the effects of surgical treatment of idiopathic macular holes. Patients are randomized to vitrectomy alone, vitrectomy plus indocyanine green (ICG) assisted inner limiting membrane ( ILM) peeling or vitrectomy plus trypan blue (tb) assisted ILM peeling. At baseline patients are characterized using early treatment diabetic retinopathy study (ETDRS) visual charts, tests of aniseikonia, optical coherence tomography 3 (OCT3), visual field and fundus photography. Per- and postoperative complications are registered.
Data analyses will help clarify the effect of ILM peeling on hole closure and visual acuity. Comparing results after ICG- and tb assisted ILM peeling will help clarify the topic of a toxic effect on retinal cells after staining and peeling of the ILM. Changes in intraretinal morphology before and after dye-assisted ILM peeling will be studied using OCT3 imaging and the patients' subjective opinion on the surgical results will be analyzed using quality of life questionnaires and metamorphopsia tests.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic macular hele stage 2 or
- •Duration of Symptoms ≤ 12 months.
- •Visual acuity ≥ 34 ETDRS letters.
- •Intraocular pressure ≤ 23 mmHg.
- •Informed consent.
排除标准
- •Previous macular hole in project eye
- •Macular pucker worse than a cellophane macular reflex.
- •Previous surgery or disease in the eye affecting retinal function.
- •Systemic disease affection vision including diabetes mellitus with level of retinopathy ≥ 14a.
- •Amblyopia i project eye.
结局指标
主要结局
Visual Acuity (ETDRS Letters)
时间窗: Visual acuity at 12 months
Visual acuity measured as the number of ETDRS letters at last follow-up
次要结局
- Anatomic Success(macular hole closure at 12 months)
- Visual Field Defects(6 months)
研究者
Ulrik Christensen
MD
Glostrup University Hospital, Copenhagen