Post Approval Study of the CyPass System

Post Approval Study of the CyPass System in Patients With Primary Open Angle Glaucoma Undergoing Cataract Surgery

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).

Study Overview

• Status: Terminated
• Conditions: Cataract; Primary Open-angle Glaucoma
• Intervention / Treatment: Device: CyPass Micro-Stent implanted with CyPass 241-S applier; Procedure: Cataract surgery

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.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Alcon Investigative Site
  • California
    • Orange, California, United States, 92868
      • Alcon Investigative Site
  • Colorado
    • Fort Collins, Colorado, United States, 80528
      • Alcon Investigative Site
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Alcon Investigative Site
    • Panama City, Florida, United States, 32405
      • Alcon Investigative Site
  • Georgia
    • Gainesville, Georgia, United States, 30501
      • Alcon Investigative Site
    • Marietta, Georgia, United States, 30060
      • Alcon Investigative Site
  • Kansas
    • Garden City, Kansas, United States, 67846
      • Alcon Investigative Site
  • Michigan
    • Fraser, Michigan, United States, 48026
      • Alcon Investigative Site
  • Missouri
    • Saint Louis, Missouri, United States, 63131
      • Alcon Investigative Site
    • Saint Louis, Missouri, United States, 63141
      • Alcon Investivative Site
  • New Jersey
    • Vineland, New Jersey, United States, 08361
      • Alcon Investigative Site
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Alcon Investigative Site
    • Chambersburg, Pennsylvania, United States, 17201
      • Alcon Investigative Site
  • Texas
    • Austin, Texas, United States, 78731
      • Alcon Investigative Site
    • El Paso, Texas, United States, 79902
      • Alcon Investigative Site
    • Houston, Texas, United States, 77030
      • Alcon Investigative Site
  • Washington
    • Bellevue, Washington, United States, 98004-3012
      • Alcon Investigative Site
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53142
      • Alcon Investigative Site
    • Racine, Wisconsin, United States, 53405
      • Alcon Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.; Procedure: Cataract surgery; Cataract surgery, followed by implantation of the CyPass Micro-Stent in one eye (the study eye) at the surgery visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Eyes With Clinically Relevant Complications Associated With CyPass Micro-Stent Placement and Stability as Determined at Month 36	Device-related complications, as specified in the protocol, included: Failure to implant CyPass, defined as inability to successfully deploy or insert the CyPass.; Clinically significant CyPass malposition, defined as CyPass positioning after deployment such that:The device is not in the supraciliary space, orClinical sequela resulting from device position including, but not limited to:Secondary surgical intervention to modify device position (eg, repositioning, proximal end trimming or explantation)Corneal endothelial touch by deviceCorneal edema leading to loss of BCDVA > 2 lines at the last postoperative visit, in comparison with preoperative BCDVAProgressive ECL, defined as ongoing reduction in endothelial cell count of 30% or more relative to the screening ECD value, where 'ongoing reduction in endothelial cell count' is defined as losses continuing after Visit 5 (6 Month Follow-up).	Up to Month 36 postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in IOP From Baseline at Month 36	Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg). A negative change value indicates an improvement.	Baseline, Month 36 postoperative
Percentage of Eyes With IOP Reduction 20 Percent or More From Baseline While Using the Same or Fewer Topical Ocular Hypotensive Medications at Month 36	Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement.	Baseline, Month 36 postoperative
Percentage of Eyes With Sight-threatening Adverse Events (AEs)	Sight-threatening adverse events, as specified in the protocol, included: Persistent Best Corrected Distance Visual Acuity (BCDVA) loss of 3 lines or more; Endophthalmitis; Corneal decompensation; Retinal detachment; Severe choroidal hemorrhage or detachment; Aqueous misdirection. Note: If an eye had multiple occurrences of an AE, the eye is presented only once in the respective eye count column (n) for the corresponding AE.	Up to Month 36 postoperative
Percentage of Eyes With Ocular Secondary Surgical Interventions (SSI)	A secondary surgical intervention may have occurred for any of the following reasons: CyPass device explantation associated with CyPass placement and stability; CyPass device explantation NOT associated with CyPass placement and stability; Unplanned ocular surgical reintervention associated with CyPass placement and stability; Unplanned ocular surgical reintervention NOT associated with CyPass placement and stability (as defined in the protocol). Note: If an eye had multiple occurrences of an AE, the eye is presented only once in the respective eye count column (n) for the corresponding AE	Up to Month 36 postoperative
Percentage of Eyes With Ocular SSIs Associated With CyPass Placement and Stability	A secondary surgical intervention may have occurred for either of the following reasons: CyPass device explantation associated with CyPass placement and stability; Unplanned ocular surgical reintervention associated with CyPass placement and stability. Note: If an eye had multiple occurrences of an AE, the eye is presented only once in the respective eye count column (n) for the corresponding AE	Up to Month 36 postoperative
Percentage of Eyes Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg at Month 36	Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg). Only one eye per subject was implanted.	Month 36 postoperative

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Sr. Clinical Trial Lead, Surgical, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2017
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: September 5, 2017
• First Submitted That Met QC Criteria: September 5, 2017
• First Posted (Actual): September 6, 2017

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: CyPass Micro-Stent
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Lens Diseases; Glaucoma; Glaucoma, Open-Angle; Cataract
• Other Study ID Numbers: GLD122c-C001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No