Post Approval Study of the CyPass System

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT03273907
Collaborator
(none)
43
Enrollment
20
Locations
1
Arm
46.6
Actual Duration (Months)
2.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

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 the COMPASS (TMI-09-01) Trial.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: CyPass Micro-Stent implanted with CyPass 241-S applier
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
43 participants
Allocation:
N/A
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 :
Oct 12, 2017
Actual Primary Completion Date :
Aug 31, 2021
Actual Study Completion Date :
Aug 31, 2021

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  1. Rate of clinically relevant complications associated with CyPass Micro-Stent placement and stability as determined at Month 36 [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 [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 [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 [Month 36 postoperative]

    IOP assessed by Goldman tonometry

  4. Rate of occurrence of sight-threatening adverse events at Month 36 [Month 36 postoperative]

    Sight-threatening adverse events, as specified in the protocol

  5. Rate of ocular secondary surgical interventions (SSI) at Month 36 [Month 36 postoperative]

  6. Rate of ocular SSIs associated with CyPass placement and stability at Month 36 [Month 36 postoperative]

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Alcon Investigative SitePhoenixArizonaUnited States85016
2Alcon Investigative SiteOrangeCaliforniaUnited States92868
3Alcon Investigative SiteFort CollinsColoradoUnited States80528
4Alcon Investigative SiteJacksonvilleFloridaUnited States32256
5Alcon Investigative SitePanama CityFloridaUnited States32405
6Alcon Investigative SiteGainesvilleGeorgiaUnited States30501
7Alcon Investigative SiteMariettaGeorgiaUnited States30060
8Alcon Investigative SiteGarden CityKansasUnited States67846
9Alcon Investigative SiteFraserMichiganUnited States48026
10Alcon Investigative SiteSaint LouisMissouriUnited States63131
11Alcon Investivative SiteSaint LouisMissouriUnited States63141
12Alcon Investigative SiteVinelandNew JerseyUnited States08361
13Alcon Investigative SiteBala-CynwydPennsylvaniaUnited States19004
14Alcon Investigative SiteChambersburgPennsylvaniaUnited States17201
15Alcon Investigative SiteAustinTexasUnited States78731
16Alcon Investigative SiteEl PasoTexasUnited States79902
17Alcon Investigative SiteHoustonTexasUnited States77030
18Alcon Investigative SiteBellevueWashingtonUnited States98004-3012
19Alcon Investigative SiteKenoshaWisconsinUnited States53142
20Alcon Investigative SiteRacineWisconsinUnited States53405

Sponsors and Collaborators

  • Alcon Research

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT03273907
Other Study ID Numbers:
  • GLD122c-C001
First Posted:
Sep 6, 2017
Last Update Posted:
Nov 9, 2021
Last Verified:
Nov 1, 2021
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
Keywords provided by Alcon Research
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 9, 2021