ISRCTN12410596已完成未知
A multicentre interventional comparative randomised controlled clinical trial comparing face-down positioning with an inactive face-forward position on the outcome of surgery for large macular holes
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 185
研究概览
简要总结
2015 protocol in https://www.ncbi.nlm.nih.gov/pubmed/26576755 2017 statistical analysis plan in https://www.ncbi.nlm.nih.gov/pubmed/28610601 2020 results in https://pubmed.ncbi.nlm.nih.gov/32379288 (added 07/05/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Presence of idiopathic full-thickness macular hole, greater than or equal to 400 µm in diameter as measured OCT
- •2. Patients electing to have surgery for macular hole, with or without simultaneous phacoemulsification and intra-ocular lens implant
- •3. Ability and willingness to position face-down or in an inactive faceforward position
- •4. Lower age limit 18 years
排除标准
- •1. Age-related macular degeneration; glaucoma; diabetic retinopathy; retinal degeneration; amblyopia; previous vitrectomy surgery (refractive error, lens opacity and previous use of ocriplasmin are not exclusion criteria)
- •2. Traumatic macular hole
- •3. History of visual loss suggesting macular hole duration longer than 12 months
- •4. Presence of a retinal tear identified during surgery for which post operative positioning is advised
研究者
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