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Post Approval Study of the CyPass System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03273907
Recruitment Status : Active, not recruiting
First Posted : September 6, 2017
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
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 the COMPASS (TMI-09-01) Trial.

Condition or disease Intervention/treatment Phase
Primary Open-angle Glaucoma Cataract Device: CyPass Micro-Stent implanted with CyPass 241-S applier Not Applicable

Detailed Description:
Each subject's expected participation in the study is up to 37.5 months which includes up to 42 days between the screening and surgery visits, and 36 months of post-surgery follow-up. Only one eye per subject will be implanted.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post Approval Study of the CyPass System in Patients With Primary Open Angle Glaucoma Undergoing Cataract Surgery
Actual Study Start Date : October 12, 2017
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Glaucoma

Arm Intervention/treatment
Experimental: CyPass System
CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery
Device: CyPass Micro-Stent implanted with CyPass 241-S applier
CyPass System (Model 241-S) consists of the CyPass Micro-Stent contained in a loading device (loader) and the CyPass applier.The CyPass Micro-Stent is an implantable medical device intended for long term use.




Primary Outcome Measures :
  1. Rate of clinically relevant complications associated with CyPass Micro-Stent placement and stability as determined at Month 36 [ Time Frame: Month 36 postoperative ]
    Clinically relevant complications related to the device, as specified in the protocol


Secondary Outcome Measures :
  1. Mean change in intraocular pressure (IOP) from baseline at Month 36 [ Time Frame: Month 36 postoperative ]
    IOP assessed by Goldman tonometry

  2. Proportion of subjects with IOP reduction ≥ 20% from baseline while using the same or fewer topical ocular hypotensive medications at Month 36 [ Time Frame: Month 36 postoperative ]
    IOP assessed by Goldman tonometry

  3. Proportion of subjects who are not using ocular hypotensive medication with IOP ≥ 6 mmHg and ≤ 18 mmHg at Month 36 [ Time Frame: Month 36 postoperative ]
    IOP assessed by Goldman tonometry

  4. Rate of occurrence of sight-threatening adverse events at Month 36 [ Time Frame: Month 36 postoperative ]
    Sight-threatening adverse events, as specified in the protocol

  5. Rate of ocular secondary surgical interventions (SSI) at Month 36 [ Time Frame: Month 36 postoperative ]
  6. Rate of ocular SSIs associated with CyPass placement and stability at Month 36 [ Time Frame: Month 36 postoperative ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03273907


Locations
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United States, Arizona
Alcon Investigative Site
Phoenix, Arizona, United States, 85016
United States, California
Alcon Investigative Site
Huntington Beach, California, United States, 92647
Alcon Investigative Site
Orange, California, United States, 92868
United States, Colorado
Alcon Investigative Site
Fort Collins, Colorado, United States, 80528
United States, Florida
Alcon Investigative Site
Jacksonville, Florida, United States, 32256
Alcon Investigative Site
Mount Dora, Florida, United States, 32757
Alcon Investigative Site
Panama City, Florida, United States, 32405
United States, Georgia
Alcon Investigative Site
Gainesville, Georgia, United States, 30501
Alcon Investigative Site
Marietta, Georgia, United States, 30060
United States, Kansas
Alcon Investigative Site
Garden City, Kansas, United States, 67846
United States, Michigan
Alcon Investigative Site
Fraser, Michigan, United States, 48026
United States, Missouri
Alcon Investigative Site
Saint Louis, Missouri, United States, 63131
Alcon Investivative Site
Saint Louis, Missouri, United States, 63131
United States, New Jersey
Alcon Investigative Site
Vineland, New Jersey, United States, 08361
United States, Pennsylvania
Alcon Investigative Site
Bala-Cynwyd, Pennsylvania, United States, 19004
Alcon Investigative Site
Chambersburg, Pennsylvania, United States, 17201
United States, Texas
Alcon Investigative Site
Austin, Texas, United States, 78731
Alcon Investigative Site
El Paso, Texas, United States, 79902
Alcon Investigative Site
Houston, Texas, United States, 77030
United States, Washington
Alcon Investigative Site
Bellevue, Washington, United States, 98004-3012
United States, Wisconsin
Alcon Investigative Site
Kenosha, Wisconsin, United States, 53142
Alcon Investigative Site
Racine, Wisconsin, United States, 53405
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Alcon, A Novartis Divisoin Alcon, A Novartis Division

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT03273907     History of Changes
Other Study ID Numbers: GLD122c-C001
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Alcon Research:
CyPass Micro-Stent

Additional relevant MeSH terms:
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Glaucoma
Cataract
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Lens Diseases