EX-PRESS® P-50 and EX-PRESS® P-200
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 122
- Locations
- 2
- Primary Endpoint
- Percentage reduction in intraocular pressure (IOP) from baseline
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Able to understand and sign an Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approved informed consent form authorizing data collection prior to the review of any medical records;
- •Implanted (one eye or both) with the EXPRESS P-50 or EXPRESS P-200 device per indications for use for at least 5 years;
- •Have a minimum of 5 years of recorded follow-up data;
- •Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- •Enrolled in any clinical trial within the last 5 years;
- •At the time of implantation:
- •Presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blepharitis.
- •Pre-existing ocular or systemic pathology that, in the opinion of the surgeon, is likely to cause postoperative complications following implantation of the device.
- •Diagnosed with angle-closure glaucoma.
- •Other protocol-defined exclusion criteria may apply.
Outcomes
Primary Outcomes
Percentage reduction in intraocular pressure (IOP) from baseline
Time Frame: Baseline (preoperative), up to Year 5 postoperative
IOP will be measured for each eye individually using applanation tonometry and recorded in millimeters mercury (mmHG).
Secondary Outcomes
No secondary outcomes reported