Comparison of Subconjunctival 5-FU Injection and Mitomycin C for Treatment of Early Bleb Failure, a Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Iop and Bleb height,extent and vascularity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts 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
- •Pregnant or nursing mothers
- •Injected bleb after bleb reconstruction
Arms & Interventions
1
5-FU injection has been done
Intervention: 5-FU and Mitomycin (Drug)
2
Mitomycin drop has been administrated
Intervention: 5-FU and Mitomycin (Drug)
Outcomes
Primary Outcomes
Iop and Bleb height,extent and vascularity
Time Frame: At least in 3 months of follow up
Secondary Outcomes
- complication of 5-FU injection or Mitomycin drop in treatment of early bleb failure