Comparison of Two Intraocular Gas Injection Techniques in Macula Hole Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- macula hole closure
研究概览
简要总结
To undertake a prospective randomized clinical trial of vitrectomy and gas tamponade to treat macular hole, utilizing a small amount of undiluted C3F8 (perfluoropropane) versus a large amount of diluted C3F8 versus a small amount of undiluted SF6 (sulfur hexafluoride) versus a large amount of diluted SF6.
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)
盲法说明
The individuals were randomized in a 1: 1: 1: 1 ratio. Block sizes of 4 individuals stratified according to gas type were used (SF6 or C3F8). In each block, two individuals were allocated to each group (0.9-1.0 mL of 100% gas or 15-20 mL of 20% gas).
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pseudophakia
- •without previous vitreoretinal surgery
- •diagnosed with a full-thickness macula hole on the optical coherence tomography exam.
- •duration of symptoms less than 6 months
- •inform consent
排除标准
- •ocular trauma
- •allergy to any of the products used in the study,
- •need to travel by plane in the first 60 postoperative days
- •myopia over 6 diopters or axial diameter over 26 mm
- •retinal dystrophies
- •retinal detachment
- •abnormal eye shape
- •diabetic retinopathy or other eye comorbidities.
研究组 & 干预措施
small amount of undiluted C3F8
干预措施: small amount of undiluted C3F8 (Drug)
large amount of diluted C3f8
干预措施: small amount of undiluted C3F8 (Drug)
small amount of undiluted SF6
干预措施: small amount of undiluted C3F8 (Drug)
large amount of diluted SF6
干预措施: small amount of undiluted C3F8 (Drug)
结局指标
主要结局
macula hole closure
时间窗: 26 weeks
closure of the macular hole after the primary surgical procedure
Gas duration
时间窗: up to 60 days
duration of intraocular gas
次要结局
- visual acuity(preoperative, 26 weeks)
- intraocular pressure(preoperative, 1 day, 26 weeks)
研究者
Rodrigo Pessoa Cavalcanti Lira
Professor
Universidade Federal de Pernambuco