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

Glaucoma Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Transscleral Diode Laser Cyclophotocoagulation Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250 Second Aqueous Shunt Transscleral 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 Jolla California 92093 United States
  • University of Southern California
    Los Angeles California 90033 United States

Details

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