A Study to Assess Long-Term Safety of the CyPass Micro-Stent in Patients Completing the COMPASS Trial
COMPASS-XT
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
2 other identifiers
interventional
282
1 country
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2016
Typical duration for not_applicable
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2016
CompletedFirst Posted
Study publicly available on registry
March 7, 2016
CompletedStudy Start
First participant enrolled
March 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 18, 2018
CompletedResults Posted
Study results publicly available
May 6, 2019
CompletedJanuary 24, 2024
May 1, 2019
2.1 years
February 28, 2016
April 10, 2019
January 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
5-year Annualized Rate (Percentage) of Sight-threatening Adverse Events, by Treatment Group
Sight-threatening adverse events occurring in the study eye included, but were not limited to: BCVA loss of ≥ 3 lines, endophthalmitis, corneal decompensation, severe retinal detachment, severe choroidal hemorrhage, severe choroidal detachment and aqueous misdirection. The number of events at the end of Year 5 was divided by the number of eyes at risk at the beginning of Year 1 for a 5-year annualized rate. The 5-year annualized rate is reported as a percentage, with the last annual non-censored rate divided by 5. Inferential testing was not planned for this endpoint.
Up to Month 60 postoperative
Secondary Outcomes (19)
Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit
Baseline, Month 12, 24, 36, 48, 60 postoperative
Number of Subjects Who Reported at Least One Protocol-specified Ocular Adverse Event in the Study Eye
Up to Month 60 postoperative
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Edema
Month 36, 48, 60 postoperative
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion
Month 36, 48, 60 postoperative
Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Cells
Month 36, 48, 60 postoperative
- +14 more secondary outcomes
Study Arms (2)
Cataract Surgery + CyPass
EXPERIMENTALCyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)
Cataract Surgery Only
ACTIVE COMPARATORCataract Surgery (COMPASS trial) with no CyPass Micro-Stent implantation
Interventions
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.
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 Criteria
You may qualify if:
- Completed the COMPASS Trial
- Understands study requirements and is willing to follow study instructions and return for study visits
You may not qualify if:
- Systemic disease that would put subject health at risk and/or prevent completion of required study visits.
- Early termination from the COMPASS Trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
- Transcend Medical, Inc.collaborator
Study Sites (22)
Alcon Investigative Site
Glendale, Arizona, 85306, United States
Alcon Investigative Site
Fayetteville, Arkansas, 72704, United States
Alcon Investigative Site
La Jolla, California, 92037, United States
Alcon Investigative Site
Orange, California, 92868, United States
Alcon Investigative Site
Fort Collins, Colorado, 80525, United States
Alcon Investigative Site
Parker, Colorado, 80134, United States
Alcon Investigative Site
Boynton Beach, Florida, 33426, United States
Alcon Investigative Site
Cape Coral, Florida, 33904, United States
Alcon Investigative Site
Sioux City, Iowa, 51104, United States
Alcon Investigative Site
Garden City, Kansas, 67846, United States
Alcon Investigative Site
Boston, Massachusetts, 02111, United States
Alcon Investigative Site
St Louis, Missouri, 63131, United States
Alcon Investigative Site
Vineland, New Jersey, 08361, United States
Alcon Investigative Site
Cincinnati, Ohio, 45242, United States
Alcon Investigative Site
Oklahoma City, Oklahoma, 73104, United States
Alcon Investigative Site
Kingston, Pennsylvania, 18704, United States
Alcon Investigative Site
West Mifflin, Pennsylvania, 15122, United States
Alcon Investigative Site
Maryville, Tennessee, 37803, United States
Alcon Investigative Site
Nashville, Tennessee, 37232, United States
Alcon Investigative Site
Dallas, Texas, 75231, United States
Alcon Investigative Site
Fort Worth, Texas, 76102, United States
Alcon Investigative Site
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr Clinical Project Lead, CDMA Surgical
- Organization
- Alcon Research
Study Officials
- STUDY DIRECTOR
Alcon, Research
Alcon Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2016
First Posted
March 7, 2016
Study Start
March 30, 2016
Primary Completion
April 18, 2018
Study Completion
April 18, 2018
Last Updated
January 24, 2024
Results First Posted
May 6, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share