Preoperative Progression of Macular Holes Using Optical Coherence Tomography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Macular hole Progression
研究概览
简要总结
Knowledge of the natural history and progression of macular holes is mainly limited to the studies from the pre-optical coherence tomography era. By observing macular holes preoperatively we are able to determine the extent of the preoperative macular hole progression.
At our institution macular holes are treated in an elective setting. The majority of macular holes undergo a 2-step sequence of phacoemulsification and intraocular lens implantation followed by vitrectomy.
We wish to observe the effect of time and cataract surgery on the progression of macular holes prior to vitrectomy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic macular hole stage II-IV
- •Informed consent
- •Duration of symptoms ≤ 24 months
排除标准
- •Previous vitreomacular surgery
- •Ocular trauma
- •Significant visual function affecting disease (proliferative diabetic retinopathy, diabetic macular edema, exudative macular degeneration)
结局指标
主要结局
Macular hole Progression
时间窗: 3 months preoperative
Serial optical coherence tomography (OCT) measurements in the preoperative period. The size of macular hole is determined by measuring the macular hole minimal linear diameter (µm). Size and stage of macular hole is determined at primary evaluation at tertiary ophthalmic center. Initial scan is followed by pre-vitrectomy scan if patient is pseudophakic. Initial OCT scan is followed by pre- and postcataract as well as pre-vitrectomy OCT scan if patient is pseudophakic.
次要结局
- Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity(3 months postoperative)
研究者
Mark Alberti
BSc.med.
Glostrup University Hospital, Copenhagen