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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2014 by Camila Fonseca Netto, Federal University of São Paulo.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01494974
First Posted: December 19, 2011
Last Update Posted: April 8, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Camila Fonseca Netto, Federal University of São Paulo
  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
Intervention Model: Parallel Assignment
Masking: Double (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 Camila Fonseca Netto, Federal University of São Paulo:

Primary Outcome Measures:
  • Position of the drainage implant plate [ Time Frame: After 1 year of surgery ]
    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 ]

    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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 10 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: December 15, 2011
First Posted: December 19, 2011
Last Update Posted: April 8, 2014
Last Verified: April 2014

Keywords provided by Camila Fonseca Netto, Federal University of São Paulo:
Glaucoma
Pediatric
Ahmed
Congenital
FP7
FP8

Additional relevant MeSH terms:
Glaucoma
Hydrophthalmos
Ocular Hypertension
Eye Diseases
Eye Abnormalities
Glaucoma, Open-Angle
Congenital Abnormalities
Infant, Newborn, Diseases


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