A Randomized, Open Label, Single Center Study Comparing the Efficacy of Macular Buckle Versus Vitrectomy on Full-thickness Macular Hole and Concurrent Macular Detachment in Eyes With Highly Myopia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Retinal re-attachment rate
研究概览
简要总结
Full-thickness macular Hole associated with macular detachment is a one of the maculopathies of high myopia. There is controversy in the primary treatment for this situation. This study will compare the effects of macular buckling versus vitrectomy in a cohort of highly myopic eyes with this situation.
详细描述
A randomized, open label, single center study comparing the efficacy of macular muckle + gas injection versus internal limiting membrane peeling + gas tamponade on full-thickness macular hole associated with macular detachment in eyes with high myopia.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •axial length ≥ 26.5 mm or refractive error (spherical equivalent) ≥ 8.0 diopter
- •full-thickness macular hole
- •macular retinal detachment
- •evidence of posterior staphyloma on clinical examination
排除标准
- •macular detachment which extended to the peripheral retina (i.e., extension beyond the major vascular arcades in more than one quadrant)
- •a history of vitrectomy or scleral buckling
- •intraocular active hemorrhage or inflammation
- •any media opacity which precluded imaging or clinical evaluation of the macula
研究组 & 干预措施
Buckle
Macular buckling, Limbal paracentesis, and intraocular gas injection.
干预措施: Buckle (Procedure)
Buckle
Macular buckling, Limbal paracentesis, and intraocular gas injection.
干预措施: Limbal paracentesis (Other)
Buckle
Macular buckling, Limbal paracentesis, and intraocular gas injection.
干预措施: Gas injection (Other)
Vitrectomy
Vitrectomy, peeling internal limiting membrane, and gas tamponade.
干预措施: Vitrectomy (Procedure)
Vitrectomy
Vitrectomy, peeling internal limiting membrane, and gas tamponade.
干预措施: Peeling internal limiting membrane (Other)
Vitrectomy
Vitrectomy, peeling internal limiting membrane, and gas tamponade.
干预措施: Gas tamponade (Other)
结局指标
主要结局
Retinal re-attachment rate
时间窗: 1 month
Successful rate of reattachment of macular retina after surgery
次要结局
- Macular hole status(3 month)
- Post-operative best corrected visual acuity(3 month)
研究者
Lin Lu
professor
Sun Yat-sen University