Outcomes of Macular Hole Surgery With Inverted Flap With vs Without Post op Posturing With SF6 in Macular Hole More Than 400 Micrometres
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 52
- 主要终点
- Anatomical Closure of the Macular Hole on OCT
研究概览
简要总结
This study evaluated the outcomes of surgery for large full-thickness macular holes measuring more than 400 micrometres using the inverted internal limiting membrane flap technique with sulphur hexafluoride (SF6) gas tamponade. The study was conducted at the Department of Ophthalmology, Lahore General Hospital, Lahore. A total of 52 male and female patients aged 52-84 years with full-thickness macular holes were included.
All patients underwent 23-gauge pars plana vitrectomy with hyaloidectomy and inverted internal limiting membrane flap surgery after staining with 0.05% Brilliant Blue. Patients were divided into two groups according to postoperative positioning. One group performed postoperative face-down posturing, whereas the other group did not perform face-down posturing. The study examined whether successful closure of large macular holes could be achieved without postoperative face-down positioning after surgery with SF6 gas tamponade.
Patients were followed on postoperative days 1, 7, 30, and 90. The main outcome was anatomical closure of the macular hole, which was assessed using optical coherence tomography (OCT). Successful treatment was defined as complete anatomical closure of the macular hole. The outcomes of patients who performed face-down posturing were compared with those who did not perform postoperative posturing to determine whether face-down positioning was necessary following surgery for macular holes larger than 400 micrometres.
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
- 52 Years 至 84 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gender: male and female
- •All patient having age between 52-84 years
- •All the patients with full thickness macular hole
- •All the patients with written informed consent
排除标准
- •Patients with high myopia.
- •Patient having age related macular degenerations (AMD).
- •Patient having any chorioretinal disease or Diabetic retinopathy.
- •Secondary MH causes
- •Cystic macular edema.
- •Age-related macular degeneration
- •Glaucoma or ocular hypertension
- •corneal opacity
- •Patient with history of previously intraocular or vitrectomy surgery other than uncomplicated cataract surgery.
- •Patient with history of previous laser photocoagulation.
- •Presence of traction on the macula (OCT).
- •Patient with significant media opacity preventing retinal view or poor image quality.
研究组 & 干预措施
Face-Down Posturing Group
Patients underwent 23-gauge pars plana vitrectomy with hyaloidectomy and inverted internal limiting membrane flap surgery after staining with 0.05% Brilliant Blue, followed by SF6 gas tamponade. After surgery, patients performed postoperative face-down posturing.
干预措施: Macular Hole Surgery With Inverted Internal Limiting Membrane Flap and SF6 Gas Tamponade (Procedure)
Face-Down Posturing Group
Patients underwent 23-gauge pars plana vitrectomy with hyaloidectomy and inverted internal limiting membrane flap surgery after staining with 0.05% Brilliant Blue, followed by SF6 gas tamponade. After surgery, patients performed postoperative face-down posturing.
干预措施: Face-Down Postoperative Positioning (Behavioral)
No Face-Down Posturing Group
Patients underwent the same 23-gauge pars plana vitrectomy with hyaloidectomy and inverted internal limiting membrane flap surgery after staining with 0.05% Brilliant Blue, followed by SF6 gas tamponade. Patients did not perform postoperative face-down posturing.
干预措施: Macular Hole Surgery With Inverted Internal Limiting Membrane Flap and SF6 Gas Tamponade (Procedure)
No Face-Down Posturing Group
Patients underwent the same 23-gauge pars plana vitrectomy with hyaloidectomy and inverted internal limiting membrane flap surgery after staining with 0.05% Brilliant Blue, followed by SF6 gas tamponade. Patients did not perform postoperative face-down posturing.
干预措施: No Face-Down Postoperative Positioning (Behavioral)
结局指标
主要结局
Anatomical Closure of the Macular Hole on OCT
时间窗: 3 months after surgery.
Proportion of participants with complete anatomical closure of the macular hole on optical coherence tomography.
次要结局
未报告次要终点
研究者
Muhammad Irfan Jamil
Principal Investigator
Lahore General Hospital
