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

Pediatric Glaucoma research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pediatric Glaucoma

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:FP7 Ahmed Glaucoma Drainage ImplantAhmed Glaucoma Valve model FP7

Device:FP8 Glaucoma Drainage ImplantAhmed Glaucoma Valve model FP8

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

FP7 implant

FP8 implant

Study Status

Unknown status

Start Date: December 2011

Completed Date:

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Position of the drainage implant plate

Secondary Outcome: As a secondary outcome, we evaluate the variation in IOP preoperative and postoperative.

Study sponsors, principal investigator, and references

Principal Investigator: Camila F Netto, MD

Lead Sponsor: Federal University of São Paulo

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01494974

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