NCT00371072

Brief Summary

In this randomized clinical trial we compare trabeculectomy with mitomycin-C (T+MMC) and Ahmed glaucoma implant (AGI) in treatment of aphakic glaucoma in children under 16 years of age.Complete and qualified success were defined as 5≤IOP≤21mmHg without and with medication respectively and we came to this point that; T+MMC and AGI are comparable in terms of success rate and complications in pediatric aphakic glaucoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2006

Completed
Last Updated

October 9, 2006

Status Verified

July 1, 2003

First QC Date

August 31, 2006

Last Update Submit

October 6, 2006

Conditions

Pediatric Aphakic Glaucoma

Keywords

Aphakic Glaucomatrabeculectomy with mitomycin- CAhmed glaucoma implant

Interventions

trabeculectomy with mitomycin-CPROCEDURE

Eligibility Criteria

Age0 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • congenital cataract
  • history of cataract surgery
  • under 16 years old
  • Ocular pressure more than 21 mmHg

You may not qualify if:

  • interruption of the follow up before 6 month
  • Anterior segment dysgenesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmic Research Center

Tehran, Tehran Province, 16666, Iran

Location

MeSH Terms

Interventions

TrabeculectomyMitomycin

Intervention Hierarchy (Ancestors)

Filtering SurgeryOphthalmologic Surgical ProceduresSurgical Procedures, OperativeMitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Mohammad Pakravan, MD

    Ophthalmic Research Center of Shaheed Beheshti Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2006

First Posted

September 1, 2006

Study Start

March 1, 2004

Study Completion

November 1, 2005

Last Updated

October 9, 2006

Record last verified: 2003-07

Locations

IR(1)