EX-PRESS® P-50 and EX-PRESS® P-200

Completed

• Conditions: Glaucoma
• Interventions: Device: EX-PRESS P-200 filtration device; Device: EX-PRESS P-50 filtration device

• Registration Number: NCT06119178
• Lead Sponsor: Alcon Research

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 Timeline

• Study First Submitted: 2023-10-31
• Study First Submitted QC: 2023-10-31
• Study First Posted: 2023-11-07
• Study Start: 2023-11-21
• Primary Completion: 2024-06-20
• Study Completion: 2024-06-20
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EX-PRESS P-200	EX-PRESS P-200 filtration device	EX-PRESS P-200 filtration device implanted in one or both eyes during glaucoma surgery
EX-PRESS P-50	EX-PRESS P-50 filtration device	EX-PRESS P-50 filtration device implanted in one or both eyes during glaucoma surgery

Primary Outcome Measures

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

Trial Locations

Locations (2)

Boozman Hoff Regional Eye Clinic; 🇺🇸 Rogers, Arkansas, United States

El Paso Eye Surgeons, PA; 🇺🇸 El Paso, Texas, United States