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

Robert Feldman

Status

Terminated

Conditions

Glaucoma

Treatments

Device: Baerveldt Glaucoma Implant 250-mm2 / BG103-250

Device: Ahmed Model FP7 Flexible Plate

Device: Baerveldt Glaucoma Implant 350-mm2 / BG101-350

Procedure: Transscleral Diode Laser Cyclophotocoagulation

Study type

Interventional

Funder types

Other

Identifiers

NCT02691455

HSC-MS-15-1053

Details and patient eligibility

About

Outcomes of subjects with uncontrolled glaucoma with a single existing aqueous tube shunt implant undergoing a second aqueous shunt to transscleral diode laser cyclophotocoagulation.

Full description

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.

Enrollment

50 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Second Aqueous Shunt

Active Comparator group

Description:

Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.

Treatment: