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

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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.

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.

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
Saint Louis, Missouri 63131
394
mi
from 43215
Saint Louis, MO
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Boston, Massachusetts 02111
643
mi
from 43215
Boston, MA
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Boynton Beach, Florida 33426
943
mi
from 43215
Boynton Beach, FL
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Cape Coral, Florida 33904
928
mi
from 43215
Cape Coral, FL
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Cincinnati, Ohio 45242
94
mi
from 43215
Cincinnati, OH
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Dallas, Texas 75231
911
mi
from 43215
Dallas, TX
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Fayetteville, Arkansas 72704
662
mi
from 43215
Fayetteville, AR
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Fort Collins, Colorado 80525
1160
mi
from 43215
Fort Collins, CO
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Fort Worth, Texas 76102
938
mi
from 43215
Fort Worth, TX
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Garden City, Kansas 67846
966
mi
from 43215
Garden City, KS
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Glendale, Arizona 85306
1665
mi
from 43215
Glendale, AZ
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Kingston, Pennsylvania 18704
384
mi
from 43215
Kingston, PA
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La Jolla, California 92037
1957
mi
from 43215
La Jolla, CA
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Maryville, Tennessee 37803
295
mi
from 43215
Maryville, TN
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Nashville, Tennessee 37232
332
mi
from 43215
Nashville, TN
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Oklahoma City, Oklahoma 73104
849
mi
from 43215
Oklahoma City, OK
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Orange, California 92868
1958
mi
from 43215
Orange, CA
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Parker, Colorado 80134
1152
mi
from 43215
Parker, CO
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San Antonio, Texas 78229
1138
mi
from 43215
San Antonio, TX
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Sioux City, Iowa 51104
715
mi
from 43215
Sioux City, IA
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Vineland, New Jersey 08361
426
mi
from 43215
Vineland, NJ
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West Mifflin, Pennsylvania 15122
168
mi
from 43215
West Mifflin, PA
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