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

NCT02691455 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-11-02

Study results available
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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.

Conditions

Interventions

DEVICE

Baerveldt Glaucoma Implant 350-mm2 / BG101-350

PROCEDURE

Transscleral Diode Laser Cyclophotocoagulation

Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

DEVICE

Ahmed Model FP7 Flexible Plate

DEVICE

Baerveldt Glaucoma Implant 250-mm2 / BG103-250

Sponsors & Collaborators

  • Robert Feldman

    lead OTHER

Principal Investigators

  • Robert Feldman, MD · Robert Cizik Eye Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2020-09-30
Completion
2020-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02691455 on ClinicalTrials.gov