Gasless Macular hole surgery
ProcedurePars plana vitrectomy to treat full thickness macular hole, with internal limiting membrane flap and ophthalmic viscosurgical device covering
NCT Number: NCT06079593
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 opening soon.
Get Notified18 year–100 year
All sexes
Interventional
Not applicable
The investigators are testing a new surgical technique, that does not use the gas bubble and face down positioning. Instead, a licensed surgical gel and thin flap of retinal tissue seal the macular hole. Early small studies suggest the new technique is safe and works as well as standard surgery.
The investigators will invite 60 people with macular hole to take part in the study. Half will be randomly allocated to the new technique and half to standard surgery. All participants will return at regular intervals after surgery for review. The investigators will test their vision, examine their eyes, and ask participants to complete questionnaires about their treatment and vision.
The investigators aim to examine if the technique appears safe and works well at closing macular holes. It will also inform if a larger clinical trial is possible.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
General:
Study eye
Pars plana vitrectomy to treat full thickness macular hole, with internal limiting membrane flap and ophthalmic viscosurgical device covering
Pars plana vitrectomy to treat full thickness macular hole, with internal limiting membrane peel, and C2F6 tamponade
Time frame: 36 months
Proportion of those screened who are randomised
Time frame: 36 months
Recruitment rate (participants per site per month)
Time frame: 6 months
Proportion reaching month 6 milestone visit
Time frame: 36 months
Proportion converting to standard vitrectomy with gas, due to inability to seal the FTMH, or detection of peripheral retinal breaks
Time frame: 6 months
Mean change from baseline
Time frame: 3 months
Proportion with FTMH closure within 3 months, without further FTMH surgery
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
Within 6 months of vitrectomy (proportion undergoing or listed for cataract surgery and mean change in Lens Opacities Classification System 2 [LOCS2] grading)
Time frame: 6 months
Assessed by the Macular Disease Treatment Satisfaction Questionnaire (MacTSQ; composite score)
Time frame: 6 months
Time frame: 6 months
Analysis of participant feedback
Contact information is provided by the study sponsor or research team.
King's College Hospital NHS Trust
Other
GaslEss Macular Hole Surgery (GEM): a Feasibility Study
Acronym: GEM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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