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Clinical Trial Summary

The purpose of this Post-Market Clinical Follow-Up (PMCF) study is to assess long term clinical performance and safety outcomes for EX-PRESS Glaucoma Filtration Devices Models P-50 and P-200.


Clinical Trial Description

This is a non-interventional/observational study designed as a retrospective chart review. Study sites will identify patient charts within their existing databases in a fair and consistent manner, e.g., reviewing all eligible charts in reverse chronological order by year of baseline visit. Patients meeting the eligibility criteria who have a minimum of 5 years of follow-up data since the implantation of the P-50 or P-200 device will be enrolled, including patients whose 5-year standard of care visit is scheduled during the study enrollment period. The overall study duration is expected to be approximately 7 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06119178
Study type Observational
Source Alcon Research
Contact
Status Enrolling by invitation
Phase
Start date November 21, 2023
Completion date July 2024

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