EX-PRESS® P-50 and EX-PRESS® P-200

Glaucoma Clinical Trial

Official title:

EX-PRESS® P-50 and EX-PRESS® P-200

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06119178
• Other study ID #: GLR516-P001
• Status: Enrolling by invitation
• Start date: November 21, 2023
• Est. completion date: July 2024

Study information

• Verified date: October 2023
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma

Intervention

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 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

Locations

Country	Name	City	State
United States	El Paso Eye Surgeons, PA	El Paso	Texas
United States	Boozman Hoff Regional Eye Clinic	Rogers	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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