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GaslEss Macular Hole Surgery

Study acronym: GEM
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated December 14, 2023 (before its estimated May 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Start date: Nov 1, 2023 to Jan 1, 2024
    • Study description expanded, about 3 words
    • Study title shortened, about 4 words
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06079593
Lead Sponsor King's College Hospital NHS Trust
Collaborators: National Institute for Health Research, United Kingdom
Conditions
(from sponsor)
Macular Holes
Related terms Retinal Perforations
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov