Status:
NOT_YET_RECRUITING
GaslEss Macular Hole Surgery
Lead Sponsor:
King's College Hospital NHS Trust
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
Conditions:
Macular Holes
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief 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. Standar...
Detailed Description
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 ho...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06079593
Start Date
January 1 2024
End Date
October 31 2026
Last Update
December 14 2023
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