Summary

for people ages 18-85 (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

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.

Official Title

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

Details

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.

Keywords

GlaucomaBaerveldt Glaucoma Implant 350-mm2 / BG101-350Transscleral Diode Laser CyclophotocoagulationAhmed Model FP7 Flexible PlateBaerveldt Glaucoma Implant 250-mm2 / BG103-250Second Aqueous ShuntTransscleral Cyclophotocoagulation

Eligibility

You can join if…

Open to people ages 18-85

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California San Diego - Shiley Eye Institute
    La JollaCalifornia92093United States
  • University of Southern California
    Los AngelesCalifornia90033United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Robert Feldman
ID
NCT02691455
Study Type
Interventional
Last Updated