Glaucoma
Conditions
Keywords
Glaucoma
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.
Interventions
DEVICEEX-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
DEVICEEX-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
Sponsors
Alcon Research
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Outcome results
None listed