Trabeculectomy With MMC Versus Ahmed Glaucoma Implant for... | NCT00371072

Studies
Trabeculectomy With MMC Versus Ahmed Glaucoma Implant for Treatment of Pediatric Aphakic Glaucoma

NCT00371072

Sponsor

Shahid Beheshti University of Medical Sciences

Status

Completed

Last Update Posted

Oct 9, 2006Estimated

Enrollment

Not provided

Phase

Phase 2Phase 3

Conditions

Pediatric Aphakic Glaucoma

Interventions

trabeculectomy with mitomycin-C

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2003

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2004

Primary Completion Date

Not provided

Completion Date

Nov 2005

First Submitted Date

Aug 31, 2006

First Submission Date that Met QC Criteria

Aug 31, 2006

First Posted Date

Sep 1, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2006

Last Update Posted Date

Oct 9, 2006Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
trabeculectomy with mitomycin-C	Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

interruption of the follow up before 6 month
Anterior segment dysgenesis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mohammad Pakravan, MD	Ophthalmic Research Center of Shaheed Beheshti Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ophthalmic Research Center		Tehran	Tehran Province	16666	Iran

Intervention Browse Module

MeSH Terms

ID	Term
D014130	Trabeculectomy
D016685	Mitomycin

Ancestor Terms

ID	Term
D018463	Filtering Surgery
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative
D008937	Mitomycins

Browse Leaves

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Browse Branches

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