Intraoperative 5-fluorouracil Augmentation of Trabeculectomy
NCT06745856 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 368
Last updated 2024-12-20
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.
Conditions
- Glaucoma
- Primary Open Angle Glaucoma
Interventions
- DRUG
-
Subconjunctival, peroperative, application of 50mg/ml concentration of 5-fluoruracil.
- DRUG
-
Subconjunctival, peroperative application of normal saline (NaCl 0.9%)
Sponsors & Collaborators
-
Moorfields Eye Hospital NHS Foundation Trust
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1996-04-30
- Primary Completion
- 2000-06-30
- Completion
- 2003-06-30
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