An interventional study of Gasless Macular hole surgery and Standard Macular hole surgery in Macular Holes, sponsored by King's College Hospital NHS Trust. Not yet recruiting. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-12-14.
Sponsored by King's College Hospital NHS Trust · Not applicable, Interventional, and Other
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:
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.
139 studies on the registry are indexed under Retinal Perforations; 22 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 94 interventional studies indexed under Retinal Perforations.
Browse Retinal Perforations studies →King's College Hospital NHS Trust is the lead sponsor of 171 studies on the registry; 56 are open to participants now.
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Exclusion Criteria:
General:
Study eye
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Gasless Macular hole surgery
Procedure: Standard Macular hole surgery
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
Feasibility: Screen failure
Proportion of those screened who are randomised
Time frame: 36 months
Feasibility: Recruitment rate
Recruitment rate (participants per site per month)
Time frame: 36 months
Feasibility: Participant retention
Proportion reaching month 6 milestone visit
Time frame: 6 months
Feasibility: Cross-over
Proportion converting to standard vitrectomy with gas, due to inability to seal the FTMH, or detection of peripheral retinal breaks
Time frame: 36 months
Efficacy Outcomes: Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA)
Mean change from baseline
Time frame: 6 months
Efficacy Outcomes: Surgical success
Proportion with FTMH closure within 3 months, without further FTMH surgery
Time frame: 3 months
Efficacy Outcomes: Area under the BCVA versus time curve (ETDRS letter score)
Time frame: 6 months
Safety outcomes: Adverse events
Time frame: 6 months
Safety outcomes: Intra- and post-operative complications
Time frame: 6 months
Safety outcomes: Development or progression of lens opacity
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
Patient reported outcomes measures: Participant acceptability of the intervention
Assessed by the Macular Disease Treatment Satisfaction Questionnaire (MacTSQ; composite score)
Time frame: 6 months
Patient reported outcomes measures: National Eye Institute 25-Item Visual Function Questionnaire (NEI VFQ25; composite score)
Time frame: 6 months
Patient reported outcomes measures: Qualitative analysis
Analysis of participant feedback
Time frame: 6 months
No study locations are listed for this record.
This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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