GaslEss Macular Hole Surgery (NCT06079593) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
GaslEss Macular Hole Surgery
60 participantsStarted 2024-01-01
Plain-language summary
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
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.