EX-PRESS® P-50 and EX-PRESS® P-200

Alcon

Status: Invitation-only

Conditions: Glaucoma

Treatments: Device: EX-PRESS P-50 filtration device; Device: EX-PRESS P-200 filtration device

Study type: Observational

Funder types: Industry

Identifiers

NCT06119178

GLR516-P001

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Key Exclusion Criteria:

• Enrolled in any clinical trial within the last 5 years;

• At the time of implantation:

  1. Presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blepharitis.
  2. Pre-existing ocular or systemic pathology that, in the opinion of the surgeon, is likely to cause postoperative complications following implantation of the device.
  3. Diagnosed with angle-closure glaucoma.

• Other protocol-defined exclusion criteria may apply.

Trial design

100 participants in 2 patient groups

EX-PRESS P-50

Description:

EX-PRESS P-50 filtration device implanted in one or both eyes during glaucoma surgery

Treatment:

Device: EX-PRESS P-50 filtration device

EX-PRESS P-200

Description:

EX-PRESS P-200 filtration device implanted in one or both eyes during glaucoma surgery

Treatment:

Device: EX-PRESS P-200 filtration device