Pneumatic Retinopexy for Primary Rhegmatogenous Retinal Detachment: To Steamroll or Not
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Macular status at Day 1
研究概览
简要总结
This is a randomized controlled trial comparing displacement of macula and the rapidity of reattachment of macula between two different positioning techniques after pneumatic retinopexy : Direct technique (patient is positioned so that the bubble is immediately placed directly over the retina break) and Steamroller technique (patient is initially positioned face down for 4-6 hours and subsequently changes their head position so that the bubble is then placed directly over the retina break).
详细描述
Pneumatic retinopexy (PR) is an established treatment for rhegmatogenous retinal detachment (RRD). In our centre, PR is the most commonly performed procedure for primary RRD repair with a high retinal reattachment success rate. In this procedure, patients are required to position according to the site of pathology following injection of an intravitreal gas bubble. Some practitioners position the patient so that the gas bubble is immediately apposed directly against the retinal break (direct technique). Others favour the steamroller technique whereby the patient is initially positioned face down, then after 4-6 hours, the position is changed sequentially so that the bubble is rolled over the retina towards the break responsible for the detachment (steamroller technique). Variable visual acuity (VA) outcomes and metamorphopsia are common post-procedure complaints despite successful RRD repair with PR. It has been suggested that variability in functional outcomes may be associated with the timing and ease of reattachment of macula. The purpose of this prospective study is to evaluate whether the steamroller technique is superior to the direct technique in faster reattachment of macula with less macula displacement.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary RRD
- •Causative breaks over superior 8 clock hours
- •Single break or group of breaks
- •No or min proliferative vitreoretinopathy (PVR) (Grade A or B)
- •Other breaks or lattice in attached retina are allowed
排除标准
- •Retinal break in the inferior 4 clock hours in detached retina
- •PVR Grade C or worse
- •Significant media opacity (Vitreous hemorrhage, dense cataract, cornea scar, etc)
- •Pre-existing ocular pathology [macula hole (MH), epiretinal membrane (ERM), cystoid macula edema (CME), age-related macula degeneration, myopic degeneration, advanced glaucoma, uveitis, amblyopia etc] or previous eye trauma with poor baseline vision
- •Previous pars plana vitrectomy
- •Age ≤18years old
- •Inadequate physical or mental competence to maintain the required postoperative head position
研究组 & 干预措施
Steamroller Technique
Following intravitreal gas injection, patient positioned face down for 4-6 hours and subsequently patient changes the position of the head so that the bubble is then placed directly over the retina break.
干预措施: Steamroller technique (Other)
Direct Technique
Following intravitreal gas injection, patient is immediately positioned so that the bubble is placed directly over the retina break.
干预措施: Direct technique (Other)
结局指标
主要结局
Macular status at Day 1
时间窗: 24hours post intervention
Assessment of macular status by optical coherence tomography at 24 hours after intervention to see which technique is most effective for reattaching the macula
次要结局
- Anatomical displacement of macula and its changes with time.(1,2, 3 and 6 months post intervention)
- Functional displacement of macula and its changes with time.(1,2, 3 and 6 months post intervention)
- Macular Status(1hour, 2hours, Day 2, Week 1, Week 2)
- Visual acuity(1, 3 and 6 months post intervention)
- Primary anatomical success(1, 3 and 6 months post intervention)
研究者
Dr. Kenneth Eng
Pneumatic Retinopexy for Primary Rhegmatogenous Retinal Detachment: To Steamroll or Not
Sunnybrook Health Sciences Centre