Prospective, Consecutive, Non-randomized,Interventional Trial of Comparative Analysis of Large Macular Hole Surgeries
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- MH status
研究概览
简要总结
This study compares the anatomical and visual outcomes in a large series of patients affected by idiopathic macular holes larger than 400 µm treated using pars plana vitrectomy and gas tamponade combined with internal limiting membrane (ILM) peeling or the inverted internal limiting membrane flap technique. A part of the participants will receive internal limiting membrane peeling,whil the other will receive the inverted internal limiting membrane flap technique.
详细描述
Vitrectomy is the standard treatment for idiopathic macular holes (IMHs) and is combined with removal of the internal limiting membrane (ILM) to improve anatomical outcomes.However, surgical closure is not achieved after a single operation in all cases, and patients with long-standing MHs or highly myopic eyes are challenging to treat.Various surgical strategies have been introduced to improve postoperative outcomes for these cases. Michalewska et al. have reported an inverted ILM flap technique for large MHs. The ILM around the MH was left to cover or fill the hole and showed a better anatomical closure rate and visual outcome than ILM peeling for large MHs. Nevertheless, the functional and anatomic outcomes of the ILM flap technique have not been investigated as extensively as the ILM peeling technique and have yet to be confirmed by research comparing the ILM flap technique with the conventional procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •idiopathic MHs, a minimum hole diameter of ≥ 400 μm, and follow-up for at least 3 months after vitrectomy.
排除标准
- •High myopia (≥6 diopters,AL≥26.5mm), increased intraocular pressure (IOP, >21 mm Hg) or glaucoma, severe cataract, severe systemic conditions that prevent surgery, and history of ocular trauma, intraocular inflammation, retinal vascular disease, or previous ocular surgery.
研究组 & 干预措施
the Fill group
the internal limiting membrane was folded in multiple layers and deliberately "stuffed" or "packed" within the MH defect using a forceps.
干预措施: the Fill group (Procedure)
the peeling group
the internal limiting membrane was discarded
干预措施: the peeling group (Procedure)
the Cover group
the internal limiting membrane was peeled centripetally all the way up to the MH rim and the hinged ILM flap folded upside-down on top of the MH in order to bridge the entire retinal defect with a single layer.
干预措施: the Cover group (Procedure)
结局指标
主要结局
MH status
时间窗: at 3 months after surgery
MH status (open, flat open or closed)
IS/OS line interruption width
时间窗: at 3 months after surgery
IS/OS line interruption width were gauged with spectral-domain optical coherence tomography
Change from Baseline IS/OS line interruption width at 3 months
时间窗: at 3 months after surgery
IS/OS line interruption width were gauged with spectral-domain optical coherence tomography
Baseline best-corrected visual acuity
时间窗: at 3 months after surgery
best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis
Change from Baseline best-corrected visual acuity at 3 months
时间窗: at 3 months after surgery
best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis
visual function
时间窗: at 3 months after surgery
visual function were gauged with national eye institute visual function questionnaire-25((NEI VFQ-25)
Change from Baseline visual function at 3 months
时间窗: at 3 months after surgery
visual function were gauged with national eye institute visual function questionnaire-25((NEI VFQ-25)
次要结局
未报告次要终点