About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Previous vitreoretinal surgery, retinopexy, open-globe injury, or endophthalmitis
Trial design
Treatments tested in this trial
- Gasless Macular hole surgery
- Standard Macular hole surgery
Treatment groups
Locations
Sponsors and collaborators
King's College Hospital NHS Trust
Lead sponsor
National Institute for Health Research, United Kingdom
Collaborator