Post Approval Study of the CyPass System in Patients with Primary Glaucoma Undergoing Cataract Surgery

Overview

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.

Mayo Clinic Location Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Syril Dorairaj, M.B.B.S., M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Non-cancer trials contact form

Phone: 800-664-4542 (toll-free)

International patient clinical studies questions