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

Use our guide to learn which trials are right for you!

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
Boston, Massachusetts 02111
?
mi
from
Boston, MA
Click here to add this to my saved trials
Boynton Beach, Florida 33426
?
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
Cape Coral, Florida 33904
?
mi
from
Cape Coral, FL
Click here to add this to my saved trials
Cincinnati, Ohio 45242
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Dallas, Texas 75231
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Fayetteville, Arkansas 72704
?
mi
from
Fayetteville, AR
Click here to add this to my saved trials
Fort Collins, Colorado 80525
?
mi
from
Fort Collins, CO
Click here to add this to my saved trials
Fort Worth, Texas 76102
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Garden City, Kansas 67846
?
mi
from
Garden City, KS
Click here to add this to my saved trials
Glendale, Arizona 85306
?
mi
from
Glendale, AZ
Click here to add this to my saved trials
Kingston, Pennsylvania 18704
?
mi
from
Kingston, PA
Click here to add this to my saved trials
La Jolla, California 92037
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Maryville, Tennessee 37803
?
mi
from
Maryville, TN
Click here to add this to my saved trials
Nashville, Tennessee 37232
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73104
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Orange, California 92868
?
mi
from
Orange, CA
Click here to add this to my saved trials
Parker, Colorado 80134
?
mi
from
Parker, CO
Click here to add this to my saved trials
Saint Louis, Missouri 63131
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Antonio, Texas 78229
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Sioux City, Iowa 51104
?
mi
from
Sioux City, IA
Click here to add this to my saved trials
Vineland, New Jersey 08361
?
mi
from
Vineland, NJ
Click here to add this to my saved trials
West Mifflin, Pennsylvania 15122
?
mi
from
West Mifflin, PA
Click here to add this to my saved trials