GaslEss Macular Hole Surgery

ConditionMacular Holes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorKing's College Hospital NHS Trust

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

60 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

King's College Hospital NHS Trust

Lead sponsor

National Institute for Health Research, United Kingdom

Collaborator