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.
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
122
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
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
Boozman Hoff Regional Eye Clinic
Rogers, Arkansas, United States
El Paso Eye Surgeons, PA
El Paso, Texas, United States
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).
Time frame: Baseline (preoperative), up to Year 5 postoperative
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