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OpenTrials
Completed

NCT Number: NCT06119178

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boozman Hoff Regional Eye Clinic, Rogers, Arkansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

Treatment and study plan

EX-PRESS P-50 filtration device

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

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

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 7, 2023
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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