NCT06119178

EX-PRESS® P-50 and EX-PRESS® P-200

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 122 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Glaucoma

Interventions

Type	Name	Description
DEVICE	EX-PRESS P-50 filtration device	FDA-approved, stainless steel device with a 50-micron internal lumen size indicated for the reduction of intraocular pressure in glaucoma patients where medical and conventional surgical treatments have failed
DEVICE	EX-PRESS P-200 filtration device	FDA-approved, stainless steel device with a 200-micron internal lumen size indicated for the reduction of intraocular pressure in glaucoma patients where medical and conventional surgical treatments have failed

Timeline

• Start date: 2023-11-21
• Primary completion: 2024-06-20
• Completion: 2024-06-20
• First posted: 2023-11-07
• Last updated: 2024-08-12

Locations

2 sites across 1 country: United States