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

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