Post Approval Study of the CyPass System
Stopped early · Not applicable
Conditions studied: Primary Open-angle Glaucoma, Cataract
In brief
The purpose of this study is to demonstrate that the rate of clinically relevant complications associated with CyPass Micro-Stent placement and stability using the CyPass 241-S applier, as determined at 36 months in the postmarket setting, is less than the pre-specified performance target, which is based on experience with the CyPass Model E applier in COMPASS trial TMI-09-01 (NCT01085357).
Key facts
- Study ID
- NCT03273907
- Run by
- Alcon Research
- People needed
- 79
- Starts
- 2017-10-12
- Expected to finish
- 2021-08-31
- Last updated by the study team
- 2024-02-16
Who can join
Age: 45 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 intraocular pressure (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.
You may not qualify if…
- 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.
Where it is running
- Alcon Investigative Site — Phoenix, Arizona, United States
- Alcon Investigative Site — Orange, California, United States
- Alcon Investigative Site — Fort Collins, Colorado, United States
- Alcon Investigative Site — Jacksonville, Florida, United States
- Alcon Investigative Site — Panama City, Florida, United States
- Alcon Investigative Site — Gainesville, Georgia, United States
- Alcon Investigative Site — Marietta, Georgia, United States
- Alcon Investigative Site — Garden City, Kansas, United States
- Alcon Investigative Site — Fraser, Michigan, United States
- Alcon Investigative Site — St Louis, Missouri, United States
- Alcon Investivative Site — St Louis, Missouri, United States
- Alcon Investigative Site — Vineland, New Jersey, United States
- Alcon Investigative Site — Bala-Cynwyd, Pennsylvania, United States
- Alcon Investigative Site — Chambersburg, Pennsylvania, United States
- Alcon Investigative Site — Austin, Texas, United States
- Alcon Investigative Site — El Paso, Texas, United States
- Alcon Investigative Site — Houston, Texas, United States
- Alcon Investigative Site — Bellevue, Washington, United States
- Alcon Investigative Site — Kenosha, Wisconsin, United States
- Alcon Investigative Site — Racine, Wisconsin, United States
Full record on ClinicalTrials.gov
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