Comparison of the Ahmed Glaucoma Valve FP7 and FP8 in Pediatric Glaucoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Federal University of São Paulo
Sponsor:
Information provided by (Responsible Party):
Camila Fonseca Netto, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01494974
First received: December 15, 2011
Last updated: April 6, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Pediatric Glaucoma
Device: FP7 Ahmed Glaucoma Drainage Implant
Device: FP8 Glaucoma Drainage Implant
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Ahmed Glaucoma Valve FP7 and FP8 in Pediatric Glaucoma: a Randomized Clinical Trial.

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Position of the drainage implant plate [ Time Frame: After 1 year of surgery ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • As a secondary outcome, we evaluate the variation in IOP preoperative and postoperative. [ Time Frame: After 1 year of surgery ] [ Designated as safety issue: No ]

    We will use as a criterion of success an IOP ≤ 21 mm Hg and> 5 mmHg and a 30% reduction of preoperative IOP. If the patient meets these criteria, without the use of eyedrop, classified as complete success. If the use of eyedrop is necessary to meet the criteria, a qualified success will be defined.

    For failure criterion is assumed: IOP ≤ 5 mmHg or > 21 mm Hg, even with the use of eye drops, need for further surgery, and / or loss of light perception.



Estimated Enrollment: 40
Study Start Date: December 2011
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: FP7 implant Device: FP7 Ahmed Glaucoma Drainage Implant
Ahmed Glaucoma Valve model FP7
Active Comparator: FP8 implant Device: FP8 Glaucoma Drainage Implant
Ahmed Glaucoma Valve model FP8

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Children older then 10 years old
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01494974

Contacts
Contact: Camila F Netto, MD +55-1199177717 milanetto@gmail.com

Locations
Brazil
Federal University of São Paulo - Ophthalmology Department Recruiting
São Paulo, Brazil, 04023-062
Contact: Camila F Netto, MD    +55-11-99177717    milanetto@gmail.com   
Principal Investigator: Camila F Netto, MD         
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Camila F Netto, MD Assistant Doctor at Ophthalmology Department
  More Information

No publications provided

Responsible Party: Camila Fonseca Netto, MD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01494974     History of Changes
Other Study ID Numbers: CEP 0236/11
Study First Received: December 15, 2011
Last Updated: April 6, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
Glaucoma
Pediatric
Ahmed
Congenital
FP7
FP8

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on August 21, 2014