NCT06745856

Intraoperative 5-fluorouracil Augmentation of Trabeculectomy

A Trial of Intraoperative 5-fluorouracil in Primary Glaucoma Filtration Surgery: Effects on Long Term Intraocular Pressure Control and Disease Progression

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 368 (actual)
• Sponsor: Moorfields Eye Hospital NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	5-fluorouracil	Subconjunctival, peroperative, application of 50mg/ml concentration of 5-fluoruracil.
DRUG	placebo	Subconjunctival, peroperative application of normal saline (NaCl 0.9%)

Timeline

• Start date: 1996-04-01
• Primary completion: 2000-06-01
• Completion: 2003-06-01
• First posted: 2024-12-20
• Last updated: 2024-12-20