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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Transcend Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01085357
First received: March 1, 2010
Last updated: October 19, 2016
Last verified: October 2016
  Purpose
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.

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: Single Blind (Subject)
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:


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 Using Non-responder Imputation for Missing Data [ Time Frame: Baseline; Month 24 postoperative ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline; Month 24 postoperative ] [ Designated as safety issue: No ]
    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 [ Time Frame: Month 24 postoperative ] [ Designated as safety issue: No ]
    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.


Enrollment: 897
Study Start Date: September 2009
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CyPass Micro-Stent + Cataract Surgery
Subjects 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.
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. The CyPass is implanted in the eye after completion of cataract surgery.
Active Comparator: Cataract Surgery Only
Subjects do 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.

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.
  Eligibility

Ages Eligible for Study:   45 Years and older   (Adult, Senior)
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
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: NCT01085357

Sponsors and Collaborators
Transcend Medical, Inc.
Investigators
Study Chair: Vice President of Medical Affairs Transcend Medical, Inc.
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Results First Received: August 25, 2016
Last Updated: October 19, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on December 09, 2016