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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Transcend Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01085357
First received: March 1, 2010
Last updated: May 21, 2013
Last verified: May 2013
History of Changes
  Purpose

This study is to evaluate the safety and efficacy of the CyPass Implant for lowering intraocular pressure in patients with glaucoma who undergo cataract surgery.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Transcend Medical, Inc.:

Primary Outcome Measures:
  • Proportion of eyes with ≥ 20% decrease in intraocular pressure (IOP) from baseline to the hypotensive medication-free 24-month postoperative examination [ Time Frame: 24 months postoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in IOP between baseline and hypotensive medication-free 24-month postoperative examination [ Time Frame: 24 months postoperative ] [ Designated as safety issue: No ]
  • Proportion of eyes with postoperative IOP ≥ 6 and ≤ 18 mmHg, as measured by Goldmann Tonometry, at the hypotensive medication-free 24-month postoperative examination [ Time Frame: 24 months postoperative ] [ Designated as safety issue: No ]

Enrollment: 897
Study Start Date: September 2009
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CyPass Micro-Stent + Cataract Surgery
Subjects in the CyPass Micro-Stent + Cataract Surgery arm of the study will receive the CyPass Micro-Stent at the conclusion of their cataract surgery.
 Device: CyPass Micro-Stent
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.
Active Comparator: Cataract Surgery
Subjects in the Cataract Surgery arm of the study will not receive the CyPass Micro-Stent at the conclusion of their 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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01085357

  Show 22 Study Locations
Sponsors and Collaborators
Transcend Medical, Inc.
  More Information

Additional Information:
Glaucoma Basics and Frequently Asked Questions  This link exits the ClinicalTrials.gov site
COMPASS Clinical Study Information Website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Transcend Medical, Inc.
ClinicalTrials.gov Identifier: NCT01085357     History of Changes
Other Study ID Numbers: TMI-09-01
Study First Received: March 1, 2010
Last Updated: May 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Transcend Medical, Inc.:
Glaucoma
Glaucoma device
Glaucoma surgery
Intraocular pressure

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

ClinicalTrials.gov processed this record on June 17, 2013