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

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