Comparison of the Ahmed Glaucoma Valve FP7 and FP8 in Pediatric Glaucoma
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|ClinicalTrials.gov Identifier: NCT01494974|
Recruitment Status : Unknown
Verified April 2014 by Camila Fonseca Netto, Federal University of São Paulo.
Recruitment status was: Recruiting
First Posted : December 19, 2011
Last Update Posted : April 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Glaucoma||Device: FP7 Ahmed Glaucoma Drainage Implant Device: FP8 Glaucoma Drainage Implant||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Comparison of the Ahmed Glaucoma Valve FP7 and FP8 in Pediatric Glaucoma: a Randomized Clinical Trial.|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||December 2015|
|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
- 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.
- 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.
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
|Contact: Camila F Netto, MDfirstname.lastname@example.org|
|Federal University of São Paulo - Ophthalmology Department||Recruiting|
|São Paulo, Brazil, 04023-062|
|Contact: Camila F Netto, MD +55-11-99177717 email@example.com|
|Principal Investigator: Camila F Netto, MD|
|Principal Investigator:||Camila F Netto, MD||Assistant Doctor at Ophthalmology Department|