Intraoperative 5-fluorouracil Augmentation of Trabeculectomy

NCT06745856 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 368

Last updated 2024-12-20

No results posted yet for this study

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

Interventions

DRUG

5-fluorouracil

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

DRUG

placebo

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06745856 on ClinicalTrials.gov