EX-PRESS P-50 filtration device
DeviceFDA-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
NCT Number: NCT06119178
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Boozman Hoff Regional Eye Clinic, Rogers, Arkansas, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
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
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).
Alcon Research
Industry
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.
Published trials that share one or more normalized conditions with this study.
NCT06960629
Corneal Diseases, Corneal Edema
Zagreb, Croatia
View Trial DetailsNCT07730424
Eye Diseases, Glaucoma
Fitzroy, Victoria, Australia
View Trial DetailsNCT07168902
Eye Diseases, Glaucoma
Glendale, California, United States
View Trial DetailsNCT04132401
Age-Related Macular Degeneration, Cardiovascular Diseases
Manresa, Barcelona, Spain
View Trial Details