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

Information source: Shahid Beheshti Medical University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bleb

Intervention: 5-FU and Mitomycin (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Shahid Beheshti Medical University

Overall contact:
Mohammad pakravan, associated professor, Phone: 22590607, Ext: 009821, Email: mopakravan@yahoo.com

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Iop and Bleb height,extent and vascularity

Secondary outcome: complication of 5-FU injection or Mitomycin drop in treatment of early bleb failure

Eligibility

Minimum age: 8 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Mohammad pakravan, associated professor, Phone: 22590607, Ext: 009821, Email: mopakravan@yahoo.com

labbafinejad Medical Center,Tehran-Boostan 9 St,Pasdaran Ave,, Tehran 16666, Iran, Islamic Republic of; Recruiting
Mohammad Pakravan, Associated professor l, Phone: 22590607, Email: mopakravan@yahoo.com
Mohammad Pakravan, Assosiated professor, Principal Investigator
Arezou Miraftabi, M.D, Sub-Investigator
Additional Information

Starting date: June 2007
Last updated: June 16, 2008

Page last updated: August 23, 2015

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