The American Glaucoma Society (AGS) Second Aqueous Shunt Implant vs. Transscleral Cyclophotocoagu… (NCT02691455) | Clinical Trial Compass
TerminatedNot Applicable
The American Glaucoma Society (AGS) Second Aqueous Shunt Implant vs. Transscleral Cyclophotocoagulation Treatment Study (ASSISTS)
Stopped: Difficulty in recruiting participants
United States50 participantsStarted 2016-02
Plain-language summary
Outcomes of subjects with uncontrolled glaucoma with a single existing aqueous tube shunt implant undergoing a second aqueous shunt to transscleral diode laser cyclophotocoagulation.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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