GEM

• Research type

  Research Study

• Full title

  GaslEss Macular hole surgery (GEM): a feasibility study

• IRAS ID

  321486

• Contact name

  George Murphy

• Contact email

  george.murphy4@nhs.net

• Sponsor organisation

  King’s College Hospital NHS Foundation Trust

• Clinicaltrials.gov Identifier

  NCT06079593

• Duration of Study in the UK

  2 years, 11 months, 31 days

• Research summary

  Aim of the research
  This study explores a new surgical technique for treating macular holes, which aims to reduce the burden of recovery from surgery. We aim to determine if the technique appears safe and effective at closing macular holes, and if a larger, definitive trial is justified and deliverable.

  Background to the research
  Macular holes are a hole in the centre of the macula, the light-sensing layer of cells in the back of the eye. They cause a central ‘blind spot’ and significant visual impairment. 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 affected eye, limiting patients’ ability to drive and work. Gas causes clouding of the natural lens in the eye (cataract) and can raise pressure inside the eye, causing pain and sometimes loss of vision. Critically, most patients are positioned face down for about a week after surgery, to float the gas bubble onto the macula. Head positioning is particularly onerous, causing discomfort in the neck, back and limbs, and occasionally life-threatening leg clots that can dislodge and travel to the lungs.

  Design and methods used
  The new surgery avoids the gas bubble and face down posturing, by instead using a licensed gel and thin flap of macular tissue to seal the macular hole. Preliminary small studies suggest the technique is safe and effective.

  The proposed study will take place at 6 NHS sites and will recruit 60 participants with previously untreated macular hole, with half randomly allocated to the new technique without gas and half to standard surgery with gas. Participants will return at regular intervals for 6 months after surgery for vision testing, eye examination, high-resolution laser scans of the macula, and to complete questionnaires about their treatment and vision.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  24/SC/0019

• Date of REC Opinion

  16 Feb 2024

• REC opinion

  Further Information Favourable Opinion