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Comparison of Subconjunctival 5-Fluorouracil (FU) Injection and Mitomycin C for Treatment of Early Bleb Failure

Comparison of Subconjunctival 5-FU Injection and Mitomycin C for Treatment of Early Bleb Failure, a Randomized Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00644215
Enrollment
40
Registered
2008-03-26
Start date
2007-06-30
Completion date
Unknown
Last updated
2008-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleb

Keywords

injected bleb, mitomycin drop, 5-Fu injection, early bleb failure

Brief summary

purpose : to evaluate and compare the effectiveness and complication of 5-FU injections and MMC drop in management of early bleb failure . Design:Randomized clinical trial Methods:Patients with low injected bleb in first month after filtering or combined surgery with MMC which don't respond to high frequent topical steroids and removal of releasable sutures will be randomize to either 5-FU injection or Mitomycin drop 0.02%.For each patient slit photograph in first day of recruiting,first two weeks and first and third month will be obtained.Patients will follow for at least 3 months and IOP ,bleb configuration will check as primary outcome measures.Preoperative and postoperative data,complications,and the need for further surgical procedures will be evaluated.

Interventions

DRUG5-FU and Mitomycin

* 5-FU injection 5mg * Mitomycin drop 0.02%

Sponsors

Shahid Beheshti University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with low,injected bleb in first month after trabeculectomy or combined trabeculectomy&phaco which not respond to high frequent topical steroids or removal of releasable sutures

Exclusion criteria

* Injected bleb due to complications of surgery such as button hole formation * Injected bleb due to blebitis * Bleb leakage * Flat AC * Pregnant or nursing mothers * Injected bleb after bleb reconstruction

Design outcomes

Primary

MeasureTime frame
Iop and Bleb height,extent and vascularityAt least in 3 months of follow up

Secondary

MeasureTime frame
complication of 5-FU injection or Mitomycin drop in treatment of early bleb failure

Countries

Iran

Contacts

Primary ContactMohammad pakravan, associated professor
mopakravan@yahoo.com22590607

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026