The AGS Second Aqueous Shunt Implant vs. Transscleral Cyclophotocoagulation Treatment Study (ASSISTS)



Status:Enrolling by invitation
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - 85
Updated:3/31/2019
Start Date:February 2016
End Date:January 2023

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The AGS Second Aqueous Shunt Implant vs. Transscleral Cyclophotocoagulation Treatment Study

Outcomes of subjects with uncontrolled glaucoma with a single existing aqueous tube shunt
implant undergoing a second aqueous shunt to transscleral diode laser cyclophotocoagulation.

This is a study comparing short- (1 year), mid- (3 years), and long-term (5 years) cumulative
incidences of failures in participants who undergo a second aqueous shunt (SAS) to those
cumulative incidences of failures in participants who undergo a second aqueous shunt (SAS) to
those cumulative incidences of failures in participants who undergo transscleral diode laser
cyclophotocoagulation (TLC) for eyes with uncontrolled glaucoma with a single existing
aqueous tube shunt procedure.

Inclusion Criteria:

- Women and men 18 to 85 years of age

- Glaucoma not adequately controlled (IOP >18 mmHg on maximum tolerated topical therapy)
with a single aqueous shunt (AS).

- Best-corrected visual acuity (BCVA) of hand motion (HM) or better in the study eye

Exclusion Criteria:

- Monocular

- Presence of more than one AS in the study eye

- Previous cyclodestruction in the study eye

- Presence of active iris neovascularization in the study eye

- Binocular diplopia

- Presence of scleral buckle in the study eye

- History or scleritis in either eye

- History of scleromalacia in the study eye

- Insufficient conjunctiva to cover AS in the study eye

- IOP cannot be accurately measured with Goldmann applanation, Pneumotonometry, or
Tono-Pen in the study eye

- Presence of silicone oil in the study eye

- Presence of retinal detachment in the study eye

- Presence of intraocular or orbital tumor affecting the study eye

- Need for cataract extraction or concurrent procedure at the time of study treatment,
except tectonic aqueous shunt revisions for both groups is allowed.

- In the opinion of the investigator, should not be enrolled in this study

- Unwilling or unable to give consent and satisfy requirements of the study
We found this trial at
23
sites
1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
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243 Charles St
Boston, Massachusetts 02114
(617) 523-7900
Principal Investigator: Ambika Hoguet, MD
Phone: 617-573-6060
Massachusetts Eye & Ear Infirmary Whether you see our physicians at Mass. Eye and Ear's...
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Boston, Massachusetts 02111
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Chapel Hill, North Carolina 27599
Principal Investigator: David Fleischman, MD
Phone: 919-843-0076
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Chesterfield, Missouri 63017
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303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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Houston, Texas 77030
Principal Investigator: Nicholas P Bell, MD
Phone: 713-559-5200
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9415 Campus Point Drive
La Jolla, California 92093
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900 Northwest 17th Street
Miami, Florida 33136
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Morgantown, West Virginia 26506
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Nashville, Tennessee 37232
Principal Investigator: Rachel Kuchtey, MD, PhD
Phone: 615-936-1639
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185 South Orange Avenue
Newark, New Jersey 07103
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Overland Park, KS
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Palm Beach Gardens, Florida 33418
Principal Investigator: Krishna Kishor, MD
Phone: 561-515-1534
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Philadelphia, Pennsylvania 19107
Principal Investigator: Anand Mantravadi, MD
Phone: 215-928-3123
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Pittsburgh, Pennsylvania 15213
Principal Investigator: Ian Conner, MD, PhD
Phone: 412-383-9884
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Portland, Oregon 97210
Principal Investigator: Steven L Mansberger, MD
Phone: 503-413-6505
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Richmond, Virginia 23226
Principal Investigator: Francis A. La Rosa, MD
Phone: 804-287-8516
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Rochelle Park, New Jersey 07062
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Seattle, Washington 98014
Principal Investigator: Joanne Wen, MD
Phone: 206-221-3121
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