Trial record 2 of 935 for:
glaucoma
Comparison of the Ahmed Glaucoma Valve FP7 and FP8 in Pediatric Glaucoma
This study is currently recruiting participants.
Verified December 2011 by Federal University of São Paulo
Sponsor:
Federal University of São Paulo
Information provided by (Responsible Party):
Camila Fonseca Netto, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01494974
First received: December 15, 2011
Last updated: December 16, 2011
Last verified: December 2011
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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:
Genetics Home Reference related topics:
early-onset glaucoma
MedlinePlus related topics:
Glaucoma
U.S. FDA Resources
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 2013 (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
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: | December 16, 2011 |
| 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 June 17, 2013