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

Robert Feldman50 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Glaucoma

Interventions

Baerveldt Glaucoma Implant 350-mm2 / BG101-350DEVICE

Transscleral Diode Laser CyclophotocoagulationPROCEDURE

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.

Ahmed Model FP7 Flexible PlateDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (23)

University of California San Diego - Shiley Eye Institute

Outcomes

Primary Outcomes

Number of Eyes That Failed Treatment

Treatment failure is defined as meeting one or more of the following 4 criteria: 1. Intraocular pressure (IOP) a) \>18 mm Hg on maximum tolerated topical IOP-lowering medications, or b) Reduction of \< 20% IOP on maximum tolerated topical IOP-lowering medications from medicated preoperative IOP, or c) ≤ 5 mm Hg without IOP-lowering medications on IOP confirmation visit, 6 months after initial study intervention; or 2. Reoperation for glaucoma; or 3. Addition of an oral CAI for the study eye on or after the 6-Month Study Visit; or 4. Loss of light perception vision (NLP).

Time frame: from time of intervention to month 6

Number of Eyes That Failed Treatment

Time frame: from month 6 to month 12

Number of Eyes That Failed Treatment

Time frame: from month 12 to year 3

Secondary Outcomes

Number of Eyes With Vision-threatening Complications

Data from ClinicalTrials.gov

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La Jolla, California, United States

University of Southern California

Los Angeles, California, United States

Bascom Palmer Eye Institute - Miami

Miami, Florida, United States

Bascom Palmer Eye Institute

Palm Beach Gardens, Florida, United States

Northwestern University - Feinberg School of Medicine

Chicago, Illinois, United States

Stiles Eyecare Excellence and Glaucoma Institute

Overland Park, Kansas, United States

New England Eye Center - Tufts Medical Center

Boston, Massachusetts, United States

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States

Glaucoma Consultants of St. Louis

Chesterfield, Missouri, United States

Rutgers; New Jersey Medical School; IOVS

Newark, New Jersey, United States

...and 13 more locations

Time frame: from the time of intervention to year 3

Number of Eyes That Lost Two or More Lines of Vision as Assessed by the Snellen Chart Visual Acuity Test

The Snellen visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). Loss of lines of vision indicates worsening visual acuity.

Time frame: from time of intervention to year 3

Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test

The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The week 1 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).

Time frame: baseline, week 1

Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test

The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The month 1 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).

Time frame: baseline, month 1

Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test

The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The month 3 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).

Time frame: baseline, month 3

Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test

The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The month 6 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).

Time frame: baseline, month 6

Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test

The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The month 12 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).

Time frame: baseline, month 12

Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test

The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The year 2 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).

Time frame: baseline, year 2

Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test

The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The year 3 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).

Time frame: baseline, year 3

Incidence of Pain

Number of participants who reported pain.

Time frame: 1 week

Incidence of Pain

Number of participants who reported pain.

Time frame: 1 month

Severity of Pain

Severity of pain was assessed by the Universal Pain Assessment Tool, and the score ranges from 0 to 10, with a higher score indicating greater pain.

Time frame: 1 week

Severity of Pain

Severity of pain was assessed by the Universal Pain Assessment Tool, and the score ranges from 0 to 10, with a higher score indicating greater pain.

Time frame: 1 month

Number of Office Visits Per Participant From Baseline to 3 Months

Time frame: from baseline to 3 months

Number of Office Visits Per Participant Per Month After Month 3

Time frame: from month 4 to year 3

Vision-related Quality of Life as Assessed by the National Eye Institute (NEI) Visual Function Questionnaire (VFQ) 25 (NEI-VFQ-25) - General Health Subscale

The score on the National Eye Institute (NEI) Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.

Time frame: baseline

Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - General Health Subscale