GaslEss Macular Hole Surgery

Launched by KING'S COLLEGE HOSPITAL NHS TRUST · Oct 6, 2023

Keywords

ClinConnect Summary

This clinical trial, called GaslEss Macular Hole Surgery, is exploring a new surgical method for treating macular holes, which are small holes in the center of the retina that can cause a central blind spot in vision. Currently, standard surgery involves injecting a gas bubble into the eye, which can make recovery challenging and painful, as patients must stay face down for much of the day for about a week. This can lead to discomfort and complications, and the gas can stay in the eye for several weeks, affecting vision and daily activities. The new technique being studied aims to make recovery easier and safer without using gas.

To be eligible for this trial, participants need to be 18 years or older and require surgery for a specific type of macular hole. They should also be able to understand and consent to the study. Throughout the trial, participants will receive either the standard surgery with gas or the new approach without gas. This study is important as it hopes to gather information that could lead to a larger trial in the future, potentially improving the experience and outcomes for patients with macular holes.

Gender

ALL

Eligibility criteria

• 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