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Trial record 1 of 1 for:    tmi-09-01e
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A Study to Assess Long-Term Safety of the CyPass Micro-Stent in Patients Completing the COMPASS Trial (COMPASS-XT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Transcend Medical, Inc.
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT02700984
First received: February 28, 2016
Last updated: August 15, 2017
Last verified: August 2017
  Purpose
The purpose of this study is to evaluate the long-term safety of the CyPass Micro-Stent in subjects who completed Study Protocol TMI-09-01, COMPASS Trial.

Condition Intervention
Primary Open Angle Glaucoma (POAG) Device: CyPass Micro-Stent Procedure: Cataract Surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Observational Multicenter Clinical Study to Assess the Long-Term Safety of the CyPass Micro-Stent in Patients With Primary Open Angle Glaucoma Who Have Completed Participation in the COMPASS Trial

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Rate of occurrence of sight-threatening adverse events [ Time Frame: Up to 60 months postoperatively ]
    Sight-threatening AEs include, but are not limited to, BCVA loss of ≥ 3 lines, endophthalmitis, corneal decompensation, severe retinal detachment, severe choroidal hemorrhage, severe choroidal detachment and aqueous misdirection.


Secondary Outcome Measures:
  • Best Corrected Visual Acuity as measured using Early Treatment Diabetic Retinopathy Study charts [ Time Frame: Up to 60 months postoperatively ]
  • Proportion of subjects reported with ocular adverse events [ Time Frame: 36 months ]
  • Proportion of subjects with clinically significant findings noted during slit lamp, gonioscopy or fundus examinations [ Time Frame: Up to 60 months postoperatively ]
  • Visual field mean deviation (MD) [ Time Frame: Up to 60 months postoperatively ]
  • Central corneal thickness [ Time Frame: Up to 60 months postoperatively ]
  • Central corneal endothelial cell density [ Time Frame: Up to 60 months postoperatively ]
  • Rate of occurrence of CyPass movement [ Time Frame: Up to 60 months postoperatively ]
  • Mean change in intraocular pressure (IOP) [ Time Frame: Up to 60 months postoperatively ]
    IOP is measured by applanation tonometry using a Goldmann tonometer

  • Proportion of subjects not using ocular hypotensive medication with ≥ 20% reduction in IOP from baseline in the COMPASS Trial [ Time Frame: Up to 60 months postoperatively ]
  • Proportion of subjects not using ocular hypotensive medication with IOP ≥ 6 mmHg and ≤ 18 mmHg [ Time Frame: Up to 60 months postoperatively ]

Enrollment: 282
Actual Study Start Date: March 30, 2016
Estimated Study Completion Date: March 30, 2018
Estimated Primary Completion Date: March 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CyPass Micro-Stent + Cataract Surgery
Subjects who received the CyPass Micro-Stent at the conclusion of their cataract surgery (COMPASS trial)
Device: CyPass Micro-Stent
The CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front into the back of the eye. The device is implanted after completion of cataract surgery.
Procedure: Cataract Surgery
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.
Active Comparator: Cataract Surgery Only
Subjects who did not receive the CyPass Micro-Stent at the conclusion of their cataract surgery (COMPASS Trial)
Procedure: Cataract Surgery
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.

Detailed Description:

The COMPASS Trial was a prospective, randomized, comparative multicenter study to assess the safety and effectiveness of the CyPass Micro-Stent in subjects with primary open angle glaucoma who were undergoing cataract surgery. In the study, 505 subjects were randomized to either the CyPass group, who underwent cataract surgery and received the CyPass Micro-Stent, or the Control group, who underwent cataract surgery alone. All subjects randomized were to be followed for 2 years postoperatively. Four hundred eighty (480) subjects completed this study.

The COMPASS-XT Trial is designed to collect safety data beyond 24 months postoperatively for subjects who completed the COMPASS Trial. In COMPASS-XT, clinical data will be collected at 36 months, 48 months, and 60 months postoperatively for a total of 5 year follow-up across the 2 studies.

  Eligibility

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

Inclusion Criteria:

  1. Completed the COMPASS Trial
  2. Understands study requirements and is willing to follow study instructions and return for study visits

Exclusion Criteria:

  1. Systemic disease that would put subject health at risk and/or prevent completion of required study visits.
  2. Early termination from the COMPASS Trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02700984

  Show 22 Study Locations
Sponsors and Collaborators
Alcon Research
Transcend Medical, Inc.
Investigators
Study Director: Alcon, A Novartis Division Alcon, A Novartis Division
  More Information

Additional Information:
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02700984     History of Changes
Other Study ID Numbers: TMI-09-01-E
GLD122b-C001 ( Other Identifier: Alcon )
Study First Received: February 28, 2016
Last Updated: August 15, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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

ClinicalTrials.gov processed this record on August 23, 2017