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Study of an Implantable Device for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery (COMPASS)

Primary Purpose

Primary Open Angle Glaucoma (POAG), Cataract

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cataract Surgery
CyPass Micro-Stent
Sponsored by
Transcend Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma (POAG) focused on measuring Glaucoma, Glaucoma device, Glaucoma surgery, Intraocular pressure

Eligibility Criteria

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

Preoperative Inclusion Criteria:

  • Diagnosis of primary open angle glaucoma (POAG)
  • Mean diurnal unmedicated IOP of 21 - 33 mmHg
  • Normal anterior chamber angle anatomy at site of implantation
  • Operable age-related cataract

Exclusion Criteria:

  • Use of more than 3 ocular hypotensive medications (combination medications count as 2 medications)
  • Significant risk associated with washout of ocular hypotensive medication
  • Previous glaucoma surgery (with exception of laser treatments to the trabecular meshwork)
  • Previous corneal surgery
  • Clinically significant ocular pathology, other than cataract and glaucoma
  • Diagnosis of acute angle closure, traumatic, congenital, malignant, uveitic, pseudoexfoliative, pigmentary or neovascular glaucoma

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    CyPass Micro-Stent + Cataract Surgery

    Cataract Surgery Only

    Arm Description

    Subjects receive the CyPass Micro-Stent at the conclusion of their cataract surgery

    Subjects do not receive the CyPass Micro-Stent at the conclusion of their cataract surgery

    Outcomes

    Primary Outcome Measures

    Proportion of Eyes With ≥ 20% Decrease in Intraocular Pressure (IOP) From Baseline to the Hypotensive Medication-free 24-month Postoperative Examination Using Non-responder Imputation for Missing Data
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement. One eye (study eye) contributed to the analysis. Proportion of eyes is reported as a percentage. Non-responders include subject eyes for which, prior to the relevant outcome time point: 1) Use of ocular hypotensive medication was not terminated; 2) IOP-affecting secondary surgical procedure was performed; 3) CyPass was explanted; or 4) CyPass was repositioned. IOP-affecting secondary surgical procedures include: Iridotomy, iridectomy, trabeculectomy, glaucoma shunt implantation, argon laser trabeculoplasty, selective laser trabeculoplasty, or other surgery that would affect IOP. Subject eyes for which CyPass implantation was attempted but not completed were treated as non-responders.

    Secondary Outcome Measures

    Mean Change in IOP Between Baseline and Hypotensive Medication-free 24-month Postoperative Examination Using Baseline Value Imputation for Missing Data
    IOP was assessed using Goldmann applanation tonometry and reported in mmHg. A negative value indicates an improvement. One eye (study eye) contributed to the analysis. Proportion of eyes is reported as a percentage. Baseline IOP was used for subject eyes for which, prior to the relevant outcome time point: 1) Use of ocular hypotensive medication was not terminated; 2) IOP-affecting secondary surgical procedure was performed; 3) CyPass was explanted; or 4) CyPass was repositioned. IOP-affecting secondary surgical procedures include: Iridotomy, iridectomy, trabeculectomy, glaucoma shunt implantation, argon laser trabeculoplasty, selective laser trabeculoplasty, or other surgery that would affect IOP. Subject eyes for which CyPass implantation was attempted but not completed were treated as non-responders.
    Proportion of Eyes With Postoperative IOP ≥ 6 and ≤ 18 mmHg, as Measured by Goldmann Tonometry, at the Hypotensive Medication-free 24-month Postoperative Examination Using Non-responder Imputation for Missing Data
    IOP was assessed using Goldmann applanation tonometry and reported in mmHg. One eye (study eye) contributed to the analysis. Proportion of eyes is reported as a percentage. Non-responders include subject eyes for which, prior to the relevant outcome time point: 1) Use of ocular hypotensive medication was not terminated; 2) IOP-affecting secondary surgical procedure was performed; 3) CyPass was explanted; or 4) CyPass was repositioned. IOP-affecting secondary surgical procedures include: Iridotomy, iridectomy, trabeculectomy, glaucoma shunt implantation, argon laser trabeculoplasty, selective laser trabeculoplasty, or other surgery that would affect IOP. Subject eyes for which CyPass implantation was attempted but not completed were treated as non-responders.

    Full Information

    First Posted
    March 1, 2010
    Last Updated
    May 12, 2017
    Sponsor
    Transcend Medical, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01085357
    Brief Title
    Study of an Implantable Device for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery
    Acronym
    COMPASS
    Official Title
    A Prospective, Randomized, Comparative, MultiCenter Clinical Study to Assess the Safety and Effectiveness of the Transcend CyPass Glaucoma Implant in Patients With Open Angle Glaucoma Undergoing Cataract Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2009 (undefined)
    Primary Completion Date
    March 2015 (Actual)
    Study Completion Date
    March 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Transcend Medical, Inc.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the safety and efficacy of the CyPass Implant for lowering intraocular pressure (IOP) in patients with glaucoma who undergo cataract surgery.
    Detailed Description
    This study is a modified and expanded protocol based on acceptable safety results from an earlier feasibility study. The trial is conducted using a 3:1 randomization (treatment to control) in which patients are screened for eligibility, randomized at time of surgery and followed for 24 months postoperatively.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Open Angle Glaucoma (POAG), Cataract
    Keywords
    Glaucoma, Glaucoma device, Glaucoma surgery, Intraocular pressure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    897 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CyPass Micro-Stent + Cataract Surgery
    Arm Type
    Experimental
    Arm Description
    Subjects receive the CyPass Micro-Stent at the conclusion of their cataract surgery
    Arm Title
    Cataract Surgery Only
    Arm Type
    Active Comparator
    Arm Description
    Subjects do not receive the CyPass Micro-Stent at the conclusion of their cataract surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    Cataract Surgery
    Intervention Description
    Cataract Surgery involves the removal of the natural lens, which has become clouded (called a cataract), and insertion of an artificial lens (called an intraocular lens). This procedure is done through a small surgical incision in the eye.
    Intervention Type
    Device
    Intervention Name(s)
    CyPass Micro-Stent
    Intervention Description
    The CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front to the back of the eye. The CyPass is implanted in the eye after completion of cataract surgery.
    Primary Outcome Measure Information:
    Title
    Proportion of Eyes With ≥ 20% Decrease in Intraocular Pressure (IOP) From Baseline to the Hypotensive Medication-free 24-month Postoperative Examination Using Non-responder Imputation for Missing Data
    Description
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement. One eye (study eye) contributed to the analysis. Proportion of eyes is reported as a percentage. Non-responders include subject eyes for which, prior to the relevant outcome time point: 1) Use of ocular hypotensive medication was not terminated; 2) IOP-affecting secondary surgical procedure was performed; 3) CyPass was explanted; or 4) CyPass was repositioned. IOP-affecting secondary surgical procedures include: Iridotomy, iridectomy, trabeculectomy, glaucoma shunt implantation, argon laser trabeculoplasty, selective laser trabeculoplasty, or other surgery that would affect IOP. Subject eyes for which CyPass implantation was attempted but not completed were treated as non-responders.
    Time Frame
    Baseline; Month 24 postoperative
    Secondary Outcome Measure Information:
    Title
    Mean Change in IOP Between Baseline and Hypotensive Medication-free 24-month Postoperative Examination Using Baseline Value Imputation for Missing Data
    Description
    IOP was assessed using Goldmann applanation tonometry and reported in mmHg. A negative value indicates an improvement. One eye (study eye) contributed to the analysis. Proportion of eyes is reported as a percentage. Baseline IOP was used for subject eyes for which, prior to the relevant outcome time point: 1) Use of ocular hypotensive medication was not terminated; 2) IOP-affecting secondary surgical procedure was performed; 3) CyPass was explanted; or 4) CyPass was repositioned. IOP-affecting secondary surgical procedures include: Iridotomy, iridectomy, trabeculectomy, glaucoma shunt implantation, argon laser trabeculoplasty, selective laser trabeculoplasty, or other surgery that would affect IOP. Subject eyes for which CyPass implantation was attempted but not completed were treated as non-responders.
    Time Frame
    Baseline; Month 24 postoperative
    Title
    Proportion of Eyes With Postoperative IOP ≥ 6 and ≤ 18 mmHg, as Measured by Goldmann Tonometry, at the Hypotensive Medication-free 24-month Postoperative Examination Using Non-responder Imputation for Missing Data
    Description
    IOP was assessed using Goldmann applanation tonometry and reported in mmHg. One eye (study eye) contributed to the analysis. Proportion of eyes is reported as a percentage. Non-responders include subject eyes for which, prior to the relevant outcome time point: 1) Use of ocular hypotensive medication was not terminated; 2) IOP-affecting secondary surgical procedure was performed; 3) CyPass was explanted; or 4) CyPass was repositioned. IOP-affecting secondary surgical procedures include: Iridotomy, iridectomy, trabeculectomy, glaucoma shunt implantation, argon laser trabeculoplasty, selective laser trabeculoplasty, or other surgery that would affect IOP. Subject eyes for which CyPass implantation was attempted but not completed were treated as non-responders.
    Time Frame
    Month 24 postoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Preoperative Inclusion Criteria: Diagnosis of primary open angle glaucoma (POAG) Mean diurnal unmedicated IOP of 21 - 33 mmHg Normal anterior chamber angle anatomy at site of implantation Operable age-related cataract Exclusion Criteria: Use of more than 3 ocular hypotensive medications (combination medications count as 2 medications) Significant risk associated with washout of ocular hypotensive medication Previous glaucoma surgery (with exception of laser treatments to the trabecular meshwork) Previous corneal surgery Clinically significant ocular pathology, other than cataract and glaucoma Diagnosis of acute angle closure, traumatic, congenital, malignant, uveitic, pseudoexfoliative, pigmentary or neovascular glaucoma
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Vice President of Medical Affairs
    Organizational Affiliation
    Transcend Medical, Inc.
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30614901
    Citation
    Ianchulev T, Lane S, Masis M, Lass JH, Benetz BA, Menegay HJ, Price FW, Lin S. Corneal Endothelial Cell Density and Morphology After Phacoemulsification in Patients With Primary Open-Angle Glaucoma and Cataracts: 2-Year Results of a Randomized Multicenter Trial. Cornea. 2019 Mar;38(3):325-331. doi: 10.1097/ICO.0000000000001826.
    Results Reference
    derived
    PubMed Identifier
    27506486
    Citation
    Vold S, Ahmed II, Craven ER, Mattox C, Stamper R, Packer M, Brown RH, Ianchulev T; CyPass Study Group. Two-Year COMPASS Trial Results: Supraciliary Microstenting with Phacoemulsification in Patients with Open-Angle Glaucoma and Cataracts. Ophthalmology. 2016 Oct;123(10):2103-12. doi: 10.1016/j.ophtha.2016.06.032. Epub 2016 Aug 6.
    Results Reference
    derived
    PubMed Identifier
    24481483
    Citation
    Jampel HD, Chon BH, Stamper R, Packer M, Han Y, Nguyen QH, Ianchulev T. Effectiveness of intraocular pressure-lowering medication determined by washout. JAMA Ophthalmol. 2014 Apr 1;132(4):390-5. doi: 10.1001/jamaophthalmol.2013.7677.
    Results Reference
    derived
    Links:
    URL
    http://www.americanglaucomasociety.net/patients/faqs
    Description
    Glaucoma Basics and Frequently Asked Questions
    URL
    http://www.CompassClinicalStudy.com
    Description
    COMPASS Clinical Study Information Website

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    Study of an Implantable Device for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery

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