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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.
Full 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.
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Key Exclusion Criteria:
Enrolled in any clinical trial within the last 5 years;
At the time of implantation:
Other protocol-defined exclusion criteria may apply.
122 participants in 2 patient groups
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Central trial contact
Alcon Call Center
Data sourced from clinicaltrials.gov
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