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

ID#: NCT02691455

Age: 18 - 85 years

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Enrolling by invitation

Start Date: February 01, 2016

End Date: January 01, 2023

Contact Information:
Melissa Tunik
212-979-4671, 646-943-7925
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.

Eligibility:



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