The No Endotamponade for Macular Hole Repair (NEMAR) Study: An International Multi-center Randomized Controlled Trial Comparing Macular Hole Closure Using Internal Limiting Membrane Flap Without Endotamponade Versus Conventional Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 3
- 主要终点
- Macular hole closure rate
研究概览
简要总结
Full-thickness macular hole (MH) is a common sight threatening macular condition with a prevalence of 3.3 per 1000 individuals. Prompt surgical repair of MH is imperative in preventing irreversible vision loss from MH as the majority of patients would experience progressive loss of central vision, often resulting in visual acuity (VA) of 20/200 or worse and the spontaneous closure rate is less than 10%.
Pars plana vitrectomy (PPV) with internal limiting membrane (ILM) peeling (with or without ILM flap) and gas tamponade, herein referred to as conventional surgery, is the current standard-of-care surgical technique in repairing MH.
Recently, a novel surgical technique that omits the need of gas tamponade to repair MH has been proposed, early results from retrospective studies were encouraging.
The purpose of this prospective international multi-centre randomised controlled study is to compare the efficacy and safety of two surgical techniques in treating MH:
- Conventional surgery: PPV with ILM peeling and gas or silicone oil tamponade
- ILM flap with no gas tamponade surgery: PPV with ILM flap with no gas tamponade
详细描述
MH is a common macular condition that requires prompt surgical intervention to prevent irreversible vision loss. Conventional surgical repair of MH involves PPV, ILM peeling and gas tamponade followed by post-operative face down posturing. The use of gas tamponade, however, is associated with impairment of vision in the early post-operative period and restriction of air travel. Moreover, fluorinated ophthalmic gases are potent green house gases that contribute to global warming.
Recently, a novel surgical technique to repair MH without endotamponade has been proposed, termed the ILM flap with no gas tamponade technique.
There is currently no published randomised controlled trial comparing the efficacy and safety of MH repair using conventional surgical technique and the ILM flap with no gas tamponade technique.
Patients with confirmed full thickness MH on optical coherence tomography will be screened and invited to join the study. Written informed consent will be obtained. Baseline screening will be performed.
Recruited study participants will be randomly allocated to one of the two study groups:
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
- •Age >= 18 years
- •Presence of full thickness macular hole in one eye (defined as full thickness discontinuity of neuro-sensory retina at the macula on optical coherence tomography)
- •Able to comply to post-operative posture
- •VA ≥0.05 and ≤0.8
排除标准
- •Fellow eye enrolled in the study
- •Eyes that underwent previous macular surgery
- •Presence of maculopathy other than macular hole, epi-retinal membrane or myopic maculopathy. For example, age-related macular degeneration, diabetic macular edema or pre-existing macular scar
- •Axial length >/= 28mm or presence of significant myopic chorio-retinal atrophy involving the fovea
- •Minimum linear diameter >/=800µm
- •Presence of contraindications to intraocular gas, such as advanced glaucoma or uncontrolled glaucoma
- •Significant macular puckering (Govetto staging ≥ stage 2)
- •Patients who are unable to give informed consent
- •Patients who are pregnant
研究组 & 干预措施
Conventional surgery
Patients would undergo conventional surgery to repair macular hole and be instructed to adopt a face-down posturing in the first 5 days following operation.
干预措施: Conventional surgery (Procedure)
Internal limiting membrane (ILM) flap with no gas tamponade
Patients would undergo macular hole repair by the ILM flap with no gas tamponade technique. Patients will be instructed to avoid excessive movement and adopt a sit up/supine posture for the first 24 hours, beyond which there will be no posturing restriction.
干预措施: ILM flap with no gas tamponade (Procedure)
结局指标
主要结局
Macular hole closure rate
时间窗: 3 months
The primary outcome is the macular hole closure rate without additional vitrectomy/macular surgery at post-operative month 3. Closure of macular hole is defined as the presence of continuous retinal tissue over the retinal pigment epithelium (RPE) without bare RPE exposed to vitreous cavity on optical coherence tomography (OCT).
Macular hole closure rate
时间窗: 3 months
The primary outcome is the macular hole closure rate without additional vitrectomy/macular surgery at post-operative month 3. Closure of macular hole is defined as the presence of continuous retinal tissue over the retinal pigment epithelium (RPE) without bare RPE exposed to vitreous cavity on optical coherence tomography (OCT).
次要结局
- Best Corrected Visual Acuity (BCVA) in the study eye(12 months)
- Pattern of macular hole closure(12 months)
- Patients reported visual function(12 months)
- Vision Preference Value Scale(12 months)
- Best Corrected Visual Acuity (BCVA) in the study eye(12 months)
- Pattern of macular hole closure(12 months)
- Rate of foveal gliosis(12 months)
- Patients reported visual function(12 months)
- Vision Preference Value Scale(12 months)
- Metamorphosia score(12 months)
研究者
Simon KH Szeto
Clinical assistant professor
Chinese University of Hong Kong