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

Stopped early · Not applicable

Conditions studied: Glaucoma

In brief

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

Key facts

Study ID

NCT02691455

Run by

Robert Feldman

People needed

50

Starts

2016-02-01

Expected to finish

2020-09-30

Last updated by the study team

2021-11-02

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California San Diego - Shiley Eye Institute — La Jolla, California, United States
• University of Southern California — Los Angeles, California, United States
• Bascom Palmer Eye Institute - Miami — Miami, Florida, United States
• Bascom Palmer Eye Institute — Palm Beach Gardens, Florida, United States
• Northwestern University - Feinberg School of Medicine — Chicago, Illinois, United States
• Stiles Eyecare Excellence and Glaucoma Institute — Overland Park, Kansas, United States
• New England Eye Center - Tufts Medical Center — Boston, Massachusetts, United States
• Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States
• Glaucoma Consultants of St. Louis — Chesterfield, Missouri, United States
• Rutgers; New Jersey Medical School; IOVS — Newark, New Jersey, United States
• Glaucoma Institute of Northern NJ, LLC — Rochelle Park, New Jersey, United States
• New York Eye and Ear Infirmary of Mount Sinai — New York, New York, United States
• Edward Harkness Eye Institute / Columbia University Medical Center — New York, New York, United States
• UNC Kittner Eye Center — Chapel Hill, North Carolina, United States
• Devers Eye Institute/Legacy Health — Portland, Oregon, United States
• Wills Eye Hospital — Philadelphia, Pennsylvania, United States
• UPMC Eye Center — Pittsburgh, Pennsylvania, United States
• Vanderbilt Eye Institute — Nashville, Tennessee, United States
• Robert Cizik Eye Clinic — Houston, Texas, United States
• University of Virginia Health System — Charlottesville, Virginia, United States
• Virginia Eye Institute — Richmond, Virginia, United States
• University of Washington Medicine Eye Institute — Seattle, Washington, United States
• WVU Eye Institute — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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