The AGS Second Aqueous Shunt Implant vs. Transscleral Cyclophotocoagulation Treatment Study (ASSISTS)
Study Phase: N/A
Recruitment Status: Enrolling by invitation
Start Date: February 01, 2016
End Date: January 01, 2023
Outcomes of subjects with uncontrolled glaucoma with a single existing aqueous tube shunt implant undergoing a second aqueous shunt to transscleral diode laser cyclophotocoagulation.
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