EX-PRESS® P-50 and EX-PRESS® P-200

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Device: EX-PRESS P-50 filtration device; Device: EX-PRESS P-200 filtration device

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 Type: Observational
• Enrollment (Actual): 122

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Rogers, Arkansas, United States, 72756
      • Boozman Hoff Regional Eye Clinic
  • Texas
    • El Paso, Texas, United States, 79922
      • El Paso Eye Surgeons, PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Cohorts will be selected from approximately 12 investigative sites located in the United States and/or outside the United States, approximately 4 countries.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EX-PRESS P-50; EX-PRESS P-50 filtration device implanted in one or both eyes during glaucoma surgery	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
EX-PRESS P-200; EX-PRESS P-200 filtration device implanted in one or both eyes during glaucoma surgery	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage reduction in intraocular pressure (IOP) from baseline	IOP will be measured for each eye individually using applanation tonometry and recorded in millimeters mercury (mmHG).	Baseline (preoperative), up to Year 5 postoperative

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Trial Lead, Vision Care, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2023
• Primary Completion (Actual): June 20, 2024
• Study Completion (Actual): June 20, 2024

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Glaucoma
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: GLR516-P001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No