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 range40 Years
SexALL
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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 …
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