A Study to Assess Long-Term Safety of the CyPass Micro-Stent in Patients Completing the COMPASS Trial
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 45 - Any |
Updated: | 5/11/2018 |
Start Date: | March 30, 2016 |
End Date: | April 18, 2018 |
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
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.
subjects who completed Study Protocol TMI-09-01, COMPASS Trial.
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.
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.
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.
We found this trial at
22
sites
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