Post Approval Study Of The CyPass System In Patients With Primary Glaucoma Undergoing Cataract Surgery
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 18-002798
Sponsor Protocol Number: 18-002798
About this study
The purpose of this study is to analyze the rate of clinically relevant
complications associated with CyPass Micro-Stent (CyPass)
as determined at 36 months in patients with primary glaucoma undergoing cataract surgery.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Able to understand the requirements of the study and willing to follow study instructions, provide written informed consent, and agree to comply with all study requirements, including the required study follow-up visits.
- Diagnosis of primary open angle glaucoma (POAG).
- Medicated IOP of ≥10 millimeters mercury (mmHg) and ≤25 mmHg, or an unmedicated IOP of ≥21 mmHg and ≤33 mmHg.
- An operable age-related cataract eligible for phacoemulsification.
- Visual acuity as specified in the protocol.
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Inability to complete a visual field test prior to surgery.
- Use of ocular hypotensive medication/s, as specified in the protocol.
- Diagnosis of glaucoma other than POAG, as specified in the protocol.
- Other medical conditions, as specified in the protocol.
- Proliferative diabetic retinopathy.
- Previous surgery for retinal detachment.
- Previous corneal surgery.
- Wet age-related macular degeneration.
- Poor vision in the non-study eye not due to cataract.
- Significant ocular inflammation or infection within 30 days of screening visit.
- Uncontrolled systemic diseases that may put the subject's health at risk and/or prevent the subject from completing all study visits.
- Women who are pregnant or nursing.
- Other protocol-specified exclusion criteria may apply.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available