NCT01494974

Brief Summary

The purpose of this study is to compare the success rates and complications of two models of Ahmed glaucoma implants (FP7 and FP8) in patients with pediatric glaucoma.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2011

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2011

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

April 8, 2014

Status Verified

April 1, 2014

Enrollment Period

4 years

First QC Date

December 15, 2011

Last Update Submit

April 6, 2014

Conditions

Pediatric Glaucoma

Keywords

GlaucomaPediatricAhmedCongenitalFP7FP8

Outcome Measures

Primary Outcomes (1)

  • Position of the drainage implant plate

    The primary endpoint is to evaluate the position of the drainage implant plate and if the plate is positioned at a distance ≥ 8 mm from the corneal limbus after 1 year of surgery, considered successful. If the plate is positioned at a distance \<8 mm from the corneal limbus, we have a failure.

    After 1 year of surgery

Secondary Outcomes (1)

  • As a secondary outcome, we evaluate the variation in IOP preoperative and postoperative.

    After 1 year of surgery

Study Arms (2)

FP7 implant

ACTIVE COMPARATOR
Device: FP7 Ahmed Glaucoma Drainage Implant

FP8 implant

ACTIVE COMPARATOR
Device: FP8 Glaucoma Drainage Implant

Interventions

FP7 Ahmed Glaucoma Drainage ImplantDEVICE

Ahmed Glaucoma Valve model FP7

FP7 implant
FP8 Glaucoma Drainage ImplantDEVICE

Ahmed Glaucoma Valve model FP8

FP8 implant

Eligibility Criteria

AgeUp to 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnostic of Pediatric Glaucoma with indication of Ahmed Glaucoma Valve implantation
  • Age from 0 to 10 years old

You may not qualify if:

  • Children older then 10 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of São Paulo - Ophthalmology Department

São Paulo, São Paulo, 04023-062, Brazil

RECRUITING

MeSH Terms

Conditions

HydrophthalmosGlaucoma

Condition Hierarchy (Ancestors)

Eye AbnormalitiesEye DiseasesGlaucoma, Open-AngleOcular HypertensionCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Camila F Netto, MD

    Assistant Doctor at Ophthalmology Department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Camila F Netto, MD

CONTACT

+55-1199177717milanetto@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 15, 2011

First Posted

December 19, 2011

Study Start

December 1, 2011

Primary Completion

December 1, 2015

Last Updated

April 8, 2014

Record last verified: 2014-04

Locations

BR(1)