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Post Approval Study of the CyPass System

Primary Purpose

Primary Open-angle Glaucoma, Cataract

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CyPass Micro-Stent implanted with CyPass 241-S applier
Cataract surgery
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open-angle Glaucoma focused on measuring CyPass Micro-Stent

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investivative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CyPass System

Arm Description

CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery

Outcomes

Primary Outcome Measures

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, or There is a clinical 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 device Corneal edema leading to loss of BCDVA > 2 lines at the last postoperative visit, in comparison with preoperative BCDVA Progressive 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)

Secondary Outcome Measures

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.
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.
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).
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.
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
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

Full Information

First Posted
September 5, 2017
Last Updated
August 24, 2022
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT03273907
Brief Title
Post Approval Study of the CyPass System
Official Title
Post Approval Study of the CyPass System in Patients With Primary Open Angle Glaucoma Undergoing Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
Voluntary market withdrawal
Study Start Date
October 12, 2017 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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 COMPASS trial TMI-09-01 (NCT01085357).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open-angle Glaucoma, Cataract
Keywords
CyPass Micro-Stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CyPass System
Arm Type
Experimental
Arm Description
CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery
Intervention Type
Device
Intervention Name(s)
CyPass Micro-Stent implanted with CyPass 241-S applier
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Cataract surgery
Intervention Description
Cataract surgery, followed by implantation of the CyPass Micro-Stent in one eye (the study eye) at the surgery visit
Primary Outcome Measure Information:
Title
Percentage of Eyes With Clinically Relevant Complications Associated With CyPass Micro-Stent Placement and Stability as Determined at Month 36
Description
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, or There is a clinical 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 device Corneal edema leading to loss of BCDVA > 2 lines at the last postoperative visit, in comparison with preoperative BCDVA Progressive 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)
Time Frame
Up to Month 36 postoperative
Secondary Outcome Measure Information:
Title
Mean Change in IOP From Baseline at Month 36
Description
Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg). A negative change value indicates an improvement.
Time Frame
Baseline, Month 36 postoperative
Title
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
Description
Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement.
Time Frame
Baseline, Month 36 postoperative
Title
Percentage of Eyes Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg at Month 36
Description
Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg).
Time Frame
Month 36 postoperative
Title
Percentage of Eyes With Sight-threatening Adverse Events (AEs)
Description
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.
Time Frame
Up to Month 36 postoperative
Title
Percentage of Eyes With Ocular Secondary Surgical Interventions (SSI)
Description
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
Time Frame
Up to Month 36 postoperative
Title
Percentage of Eyes With Ocular SSIs Associated With CyPass Placement and Stability
Description
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
Time Frame
Up to Month 36 postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sr. Clinical Trial Lead, Surgical
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigative Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Alcon Investigative Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Alcon Investigative Site
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Alcon Investigative Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Alcon Investigative Site
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
Alcon Investigative Site
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Alcon Investigative Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Alcon Investigative Site
City
Garden City
State/Province
Kansas
ZIP/Postal Code
67846
Country
United States
Facility Name
Alcon Investigative Site
City
Fraser
State/Province
Michigan
ZIP/Postal Code
48026
Country
United States
Facility Name
Alcon Investigative Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Alcon Investivative Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Alcon Investigative Site
City
Vineland
State/Province
New Jersey
ZIP/Postal Code
08361
Country
United States
Facility Name
Alcon Investigative Site
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Alcon Investigative Site
City
Chambersburg
State/Province
Pennsylvania
ZIP/Postal Code
17201
Country
United States
Facility Name
Alcon Investigative Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Alcon Investigative Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Alcon Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Alcon Investigative Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004-3012
Country
United States
Facility Name
Alcon Investigative Site
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53142
Country
United States
Facility Name
Alcon Investigative Site
City
Racine
State/Province
Wisconsin
ZIP/Postal Code
53405
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Post Approval Study of the CyPass System

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