GaslEss Macular Hole Surgery (GEM)

King's College Hospital NHS Trust

Status

Not yet enrolling

Conditions

Macular Holes

Treatments

Procedure: Gasless Macular hole surgery

Procedure: Standard Macular hole surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT06079593

204994

Details and patient eligibility

About

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

Full 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 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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