Intraoperative 5-fluorouracil Augmentation of Trabeculectomy

NCT ID: NCT06745856

Last Updated: 2024-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 368 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-04-30
• Study Completion Date: 2003-06-30

Brief 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.

Detailed Description

Glaucoma is the commonest cause of irreversible blindness worldwide. Treatment is initially with topical medication, but when the intraocular pressure is still poorly controlled, surgical treatment is required. The surgical treatment of choice remains the trabeculectomy and this is often augmented with antimetabolite.

The choice of antimetabolite varies between surgeons, as does the indications for use. Postoperative delivery of the drug can be uncomfortable for the patient and time consuming. This study examines the potential benefits and side effect profile of intraoperative 5FU compared to unaugmented trabeculectomy.

The patients are recruited from Moorfields Eye Hospital and followed up by the staff from the glaucoma department.

Conditions

Glaucoma; Primary Open Angle Glaucoma

Keywords

glaucoma; trabeculectomy; intraocular pressure; randomized control study; antimetabolite; 5 fluorouracil

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

5-fluorouracil

antimetabolite to prevent wound healing

Group Type: ACTIVE_COMPARATOR

5-fluorouracil

Intervention Type: DRUG

Subconjunctival, peroperative, application of 50mg/ml concentration of 5-fluoruracil.

placebo

Subconjunctival placebo.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Subconjunctival, peroperative application of normal saline (NaCl 0.9%)

Interventions

5-fluorouracil

Subconjunctival, peroperative, application of 50mg/ml concentration of 5-fluoruracil.

Intervention Type: DRUG

placebo

Subconjunctival, peroperative application of normal saline (NaCl 0.9%)

Intervention Type: DRUG

Other Intervention Names

5 fluorouracil subconjunctival injection; sodium chloride solution (0.9%)"

Eligibility Criteria

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 treatment. A pregnancy test will be performed on all women of childbearing age to rule out pregnancy.
• Cataract that is deemed significant enough to require surgery during the course of the trial or that makes field testing or optic disc recording by either photography or the scanning laser ophthalmoscope unreliable or not technically possible.
• Any medical condition likely to prevent the patient from regularly attending for the next three years
• Previous conjunctival surgery at proposed site of trabeculectomy
• Chronic use of topical or systemic steroids
• Previous squint surgery

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Moorfields Eye Hospital NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

G9330070

Identifier Type: -

Identifier Source: org_study_id