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
Cincinnati, Ohio 45242
1882
mi
from 91732
Cincinnati, OH
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Boston, Massachusetts 02111
2578
mi
from 91732
Boston, MA
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Boynton Beach, Florida 33426
2309
mi
from 91732
Boynton Beach, FL
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Cape Coral, Florida 33904
2200
mi
from 91732
Cape Coral, FL
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Dallas, Texas 75231
1223
mi
from 91732
Dallas, TX
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Fayetteville, Arkansas 72704
1352
mi
from 91732
Fayetteville, AR
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Fort Collins, Colorado 80525
839
mi
from 91732
Fort Collins, CO
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Fort Worth, Texas 76102
1195
mi
from 91732
Fort Worth, TX
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Garden City, Kansas 67846
993
mi
from 91732
Garden City, KS
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Glendale, Arizona 85306
336
mi
from 91732
Glendale, AZ
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Kingston, Pennsylvania 18704
2332
mi
from 91732
Kingston, PA
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La Jolla, California 92037
16
mi
from 91732
La Jolla, CA
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Maryville, Tennessee 37803
1922
mi
from 91732
Maryville, TN
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Nashville, Tennessee 37232
1763
mi
from 91732
Nashville, TN
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Oklahoma City, Oklahoma 73104
1165
mi
from 91732
Oklahoma City, OK
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Orange, California 92868
21
mi
from 91732
Orange, CA
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Parker, Colorado 80134
822
mi
from 91732
Parker, CO
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Saint Louis, Missouri 63131
1573
mi
from 91732
Saint Louis, MO
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San Antonio, Texas 78229
1188
mi
from 91732
San Antonio, TX
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Sioux City, Iowa 51104
1303
mi
from 91732
Sioux City, IA
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Vineland, New Jersey 08361
2385
mi
from 91732
Vineland, NJ
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West Mifflin, Pennsylvania 15122
2126
mi
from 91732
West Mifflin, PA
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