GaslEss Macular Hole Surgery (GEM): a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Feasibility: Recruitment rate
研究概览
简要总结
Macular holes are a hole in the centre of the retina, the light-sensing layer in the back of the eye. They cause a central 'blind spot' in the vision, which can be very disabling for patients. Standard surgery involves injecting a large gas bubble inside the eye. This takes 4-8 weeks to leave the eye. During this time vision is greatly reduced in the eye. This limits patients' ability to drive and work. Gas causes clouding of the natural lens in the eye (cataract). The gas can also raise pressure inside the eye, causing pain and sometimes loss of vision. Patients cannot fly or have certain medicines until the gas absorbs.
Critically, most patients position face down for 50 minutes out of every hour for a week after surgery. This is to float the gas bubble onto the macula. Head positioning is particularly difficult. It very often causes pain in the neck, back, arms and legs. Rarely, blood clots can form in the legs and be life-threatening if they dislodge and travel to the lungs. Head positioning also places a large burden on those caring for the patient.
The gases are 'greenhouse' gases and cause damage to the environment, for about 3,200 years.
This study looks at a new surgical technique for treating macular holes. The new technique aims to make patients' recovery from surgery easier, and safer.
The purpose of this study therefore is to compare two treatments:
- Standard macular hole surgery with gas tamponade
- Novel macular hole surgery without tamponade Gathering feasibility data to inform a future fully powered trial
详细描述
The investigators are testing a new surgical technique, that does not use the gas bubble and face down positioning. Instead, a licensed surgical gel and thin flap of retinal tissue seal the macular hole. Early small studies suggest the new technique is safe and works as well as standard surgery.
The investigators will invite 60 people with macular hole to take part in the study. Half will be randomly allocated to the new technique and half to standard surgery. All participants will return at regular intervals after surgery for review. The investigators will test their vision, examine their eyes, and ask participants to complete questionnaires about their treatment and vision.
The investigators aim to examine if the technique appears safe and works well at closing macular holes. It will also inform if a larger clinical trial is possible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Images will be graded in a masked fashion
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Requiring PPV to treat idiopathic (primary) FTMH.
- •18 years or older
- •ETDRS BCVA letter score of 1 or better in the study eye
- •Able to provide written informed consent
排除标准
- •Hypersensitivity to hyaluronate or other components of Healon Pro® viscoelastic
- •Any major illness or major surgical procedure within 4 weeks
- •Any other condition that, in the opinion of the investigator, would prevent the participant from granting informed consent or complying with the protocol
- •Previous vitreoretinal surgery, retinopexy, open-globe injury, or endophthalmitis
- •Presence of fibrotic retinal proliferation or central epiretinal membrane (within 1 disc diameter of the fovea)
- •Current or former myopia greater than 6 dioptres
- •Current or previous posterior uveitis or choroiditis
- •Presence of other ocular co-morbidity that, in the opinion of the investigator, is likely to impair BCVA postoperatively or affect FTMH closure
- •Current ocular or periocular infection, other than mild or moderate blepharitis
- •Lens or media opacity that preclude adequate retinal assessment and imaging
结局指标
主要结局
Feasibility: Recruitment rate
时间窗: 36 months
Recruitment rate (participants per site per month)
Feasibility: Participant retention
时间窗: 6 months
Proportion reaching month 6 milestone visit
Feasibility: Screen failure
时间窗: 36 months
Proportion of those screened who are randomised
Feasibility: Cross-over
时间窗: 36 months
Proportion converting to standard vitrectomy with gas, due to inability to seal the FTMH, or detection of peripheral retinal breaks
次要结局
- Safety outcomes: Adverse events(6 months)
- Safety outcomes: Development or progression of lens opacity(6 months)
- Patient reported outcomes measures: Qualitative analysis(6 months)
- Efficacy Outcomes: Surgical success(3 months)
- Patient reported outcomes measures: Participant acceptability of the intervention(6 months)
- Efficacy Outcomes: Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA)(6 months)
- Safety outcomes: Intra- and post-operative complications(6 months)
- Patient reported outcomes measures: National Eye Institute 25-Item Visual Function Questionnaire (NEI VFQ25; composite score)(6 months)
- Efficacy Outcomes: Area under the BCVA versus time curve (ETDRS letter score)(6 months)