Internal Limiting Membrane Peeling in Macula-off Retinal Detachment With Grade B Proliferative Vitreoretinopathy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
- 主要终点
- Primary anatomical success rate
研究概览
简要总结
Despite advances in surgical techniques over the recent decades, proliferative vitreoretinopathy (PVR) remains the main obstacle to successful rhegmatogenous retinal detachment (RRD) repair, accounting for nearly 75% of all primary surgical failures. It is characterized by the growth and contraction of cellular membranes within the vitreous cavity and on both surfaces of the detached retina as well as intraretinal fibrosis.
The Retina Society classification, modified in 1991 and currently the most widely used, divided PVR into three grades. Grade A is limited to the presence of vitreous haze and pigment clumps. Grade B includes rolled or irregular edges of tear and/or inner retinal surface wrinkling with possible retinal stiffness and vessel tortuosity. Grade C is defined as the presence of full-thickness fixed retinal folds and is further subdivided based on the number of hours involved and the location.
Recently, Foveau et al., in a retrospective comparative case series, have demonstrated that performing internal limiting membrane (ILM) peeling during RRD surgery may increase the anatomical success rate for this indication.
The aim of this multi-center, prospective, randomized controlled clinical trial study is to evaluate the effectiveness of ILM peeling on surgical outcomes in patients with primary macula-off RRD complicated by grade B PVR.
详细描述
Despite advances in surgical techniques over the recent decades, proliferative vitreoretinopathy (PVR) remains the main obstacle to successful rhegmatogenous retinal detachment (RRD) repair, accounting for nearly 75% of all primary surgical failures. It is characterized by the growth and contraction of cellular membranes within the vitreous cavity and on both surfaces of the detached retina as well as intraretinal fibrosis.
The Retina Society classification, modified in 1991 and currently the most widely used, divided PVR into three grades. Grade A is limited to the presence of vitreous haze and pigment clumps. Grade B includes rolled or irregular edges of tear and/or inner retinal surface wrinkling with possible retinal stiffness and vessel tortuosity. Grade C is defined as the presence of full-thickness fixed retinal folds and is further subdivided based on the number of hours involved and the location.
Grade B PVR is thought to represent an immature form of PVR with a definite potential for progression to further stages of PVR. Specific treatment for moderate PVR seems to be essential to halt the disease process and to reduce the risk of postoperative re-detachment. However, there is currently no consensus regarding the management of grade PVR. In macula-off RRD, vitrectomy with gas tamponade is often used as a primary option, with a retinal reattachment rate of 60%.
Recently, Foveau et al., in a retrospective comparative case series, have demonstrated that performing internal limiting membrane (ILM) peeling during RRD surgery may increase the anatomical success rate for this indication.
The aim of this multi-center, prospective, randomized controlled clinical trial study is to evaluate the effectiveness of ILM peeling on surgical outcomes in patients with primary macula-off RRD complicated by grade B PVR.
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
- 是
入选标准
- •Patients older than 18 years old
- •With macula-off retinal detachment complicated by grade B proliferative vitreoretinopathy
排除标准
- •Underage patients
- •History of retinal detachment
- •History of intraocular surgery (except for cataract surgery)
- •Traumatic retinal detachment
- •Macular hole-associated retinal detachment
- •Concurrent macular disease (diabetic maculopathy, age-related macular degeneration)
结局指标
主要结局
Primary anatomical success rate
时间窗: 12 months after surgery
Primary retinal reattachment rate
次要结局
- Anatomical outcomes #2(12 months after surgery)
- Anatomical outcomes #1(12 months after surgery)
- Functional outcomes #1(12 months after surgery)
- Functional outcomes #2(12 months after surgery)
- Anatomical outcomes #3(12 months after surgery)
- Anatomical outcomes #4(12 months after surgery)
- Functional outcomes #3(12 months after surgery)