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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Gasless Macular hole surgery
Procedure/SurgeryPars plana vitrectomy to treat full thickness macular hole, with internal limiting membrane flap and ophthalmic viscosurgical device covering
Standard Macular hole surgery
Procedure/SurgeryPars plana vitrectomy to treat full thickness macular hole, with internal limiting membrane peel, and C2F6 tamponade
Treatment groups
Trial outcomes
Primary outcomes
Feasibility: Screen failure
Proportion of those screened who are randomised
Feasibility: Recruitment rate
Recruitment rate (participants per site per month)
Feasibility: Participant retention
Proportion reaching month 6 milestone visit
Feasibility: Cross-over
Proportion converting to standard vitrectomy with gas, due to inability to seal the FTMH, or detection of peripheral retinal breaks
Secondary outcomes
Efficacy Outcomes: Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA)
Mean change from baseline
Efficacy Outcomes: Surgical success
Proportion with FTMH closure within 3 months, without further FTMH surgery
Efficacy Outcomes: Area under the BCVA versus time curve (ETDRS letter score)
Safety outcomes: Adverse events
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
King's College Hospital NHS Trust
Lead sponsor
National Institute for Health Research, United Kingdom
Collaborator
This trial is not recruiting at the moment. You can still explore other options: