GaslEss Macular Hole Surgery

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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GaslEss Macular Hole Surgery (GEM): a Feasibility Study

Conditions
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Macular Holes

Intervention / Treatment
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* Procedure: Gasless Macular hole surgery
* Procedure: Standard Macular hole surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: General: 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 Study eye 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) Aphakia 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gasless Surgery<br> | Procedure: Gasless Macular hole surgery<br>* Pars plana vitrectomy to treat full thickness macular hole, with internal limiting membrane flap and ophthalmic viscosurgical device covering<br>|
| Active Comparator: Standard surgery with gas tamponade<br> | Procedure: Standard Macular hole surgery<br>* Pars plana vitrectomy to treat full thickness macular hole, with internal limiting membrane peel, and C2F6 tamponade<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility: Screen failure | Proportion of those screened who are randomised | 36 months | 
| Feasibility: Recruitment rate | Recruitment rate (participants per site per month) | 36 months | 
| Feasibility: Participant retention | Proportion reaching month 6 milestone visit | 6 months | 
| Feasibility: Cross-over | Proportion converting to standard vitrectomy with gas, due to inability to seal the FTMH, or detection of peripheral retinal breaks | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Outcomes: Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) | Mean change from baseline | 6 months | 
| Efficacy Outcomes: Surgical success | Proportion with FTMH closure within 3 months, without further FTMH surgery | 3 months | 
| Efficacy Outcomes: Area under the BCVA versus time curve (ETDRS letter score) |  | 6 months | 
| Safety outcomes: Adverse events |  | 6 months | 
| Safety outcomes: Intra- and post-operative complications |  | 6 months | 
| Safety outcomes: Development or progression of lens opacity | Within 6 months of vitrectomy (proportion undergoing or listed for cataract surgery and mean change in Lens Opacities Classification System 2 [LOCS2] grading) | 6 months | 
| Patient reported outcomes measures: Participant acceptability of the intervention | Assessed by the Macular Disease Treatment Satisfaction Questionnaire (MacTSQ; composite score) | 6 months | 
| Patient reported outcomes measures: National Eye Institute 25-Item Visual Function Questionnaire (NEI VFQ25; composite score) |  | 6 months | 
| Patient reported outcomes measures: Qualitative analysis | Analysis of participant feedback | 6 months |