Intraoperative 5-fluorouracil Augmentation of Trabeculectomy (NCT06745856) | Clinical Trial Compass
CompletedPhase 3
Intraoperative 5-fluorouracil Augmentation of Trabeculectomy
368 participantsStarted 1996-04
Plain-language summary
5-fluorouracil (5FU) is an antimetabolite that has been demonstrated to have beneficial effects when injected into the subconjunctival space after glaucoma surgery (trabeculectomy). The hypothesis of this study is that a similar beneficial effect can be achieved with a single intraoperative application of 5FU. This hypothesis is tested with a randomized control study.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* A measured intraocular pressure \> or equal to 22 mm Hg on at least one visit before the time of listing for surgery and while on the current drop regime.
* The ability to complete a Humphrey 24-2 visual field test with \<20% false positives, \<33% false negatives and \<20% fixation losses, and the presence of 2 locations \> 5decibels (dB) less than normal or one location \>10 dB less than normal.
* The presence of a focal or diffuse area of optic disc rim loss, as shown by a reduction of optic rim thickness to less than one tenth of disc diameter at any point on the disc. (alternatively, optic disc which in the opinion of the patient's consultant shows glaucomatous changes as shown by focal or diffuse optic rim thinning)
Exclusion Criteria:
* Anterior segment neovascularisation
* Any intraocular epithelial ingrowth
* Retinal or optic nerve neovascularisation
* Aphakia
* Previous glaucoma filtering surgery
* Uveitis
* Any previous intraocular surgery
* Inability or unwillingness to give informed consent
* Inability or unwillingness to return for postoperative follow-up as prescribed in the trial regimen
* Unwillingness to accept randomisation
* Patient less than 40 years of age
* Chemotherapy in the 6 weeks prior to surgery
* Any other disease causing visual field loss or likely to cause field loss over the next three years e.g. diabetic retinopathy, pituitary disease or stroke.
* Pregnancy or female of childbearing age who may be pregnant at time of …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Glaucoma control
Timeframe: a minimum of 3 years follow up
Trial details
NCT IDNCT06745856
SponsorMoorfields Eye Hospital NHS Foundation Trust