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

NCT ID: NCT00644215

Last Updated: 2008-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bleb

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

injected bleb mitomycin drop 5-Fu injection early bleb failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

5-FU injection has been done

Group Type EXPERIMENTAL

5-FU and Mitomycin

Intervention Type DRUG

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

2

Mitomycin drop has been administrated

Group Type EXPERIMENTAL

5-FU and Mitomycin

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

5-FU and Mitomycin

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

ophthalmic research center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

labbafinejad Medical Center,Tehran-Boostan 9 St,Pasdaran Ave,

Tehran, Tehran Province, Iran

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Iran

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mohammad pakravan, associated professor

Role: CONTACT

Phone: 22590607

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mohammad Pakravan, Associated professor l

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

8662

Identifier Type: -

Identifier Source: org_study_id