Clinical trial NCT02691455: The American Glaucoma Society (AGS) Second Aqueous Shunt Implant vs. Transscleral Cyclophotocoagulation Treatment Study (ASSISTS)
Official title: The AGS Second Aqueous Shunt Implant vs. Transscleral Cyclophotocoagulation Treatment Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Glaucoma
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2016-02-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Eyes That Failed Treatment
timeFrame: from time of intervention to month 6
measure: Number of Eyes That Failed Treatment
timeFrame: from month 6 to month 12
measure: Number of Eyes That Failed Treatment
timeFrame: from month 12 to year 3
Secondary outcomes:
measure: Number of Eyes With Vision-threatening Complications
timeFrame: from the time of intervention to year 3
measure: Number of Eyes That Lost Two or More Lines of Vision as Assessed by the Snellen Chart Visual Acuity Test
timeFrame: from time of intervention to year 3
measure: Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
timeFrame: baseline, week 1
measure: Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
timeFrame: baseline, month 1
measure: Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
timeFrame: baseline, month 3
measure: Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
timeFrame: baseline, month 6
measure: Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
timeFrame: baseline, month 12
measure: Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
timeFrame: baseline, year 2
measure: Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
timeFrame: baseline, year 3
measure: Incidence of Pain
timeFrame: 1 week
measure: Incidence of Pain
timeFrame: 1 month
measure: Severity of Pain
timeFrame: 1 week
measure: Severity of Pain
timeFrame: 1 month
measure: Number of Office Visits Per Participant From Baseline to 3 Months
timeFrame: from baseline to 3 months
measure: Number of Office Visits Per Participant Per Month After Month 3
timeFrame: from month 4 to year 3
measure: Vision-related Quality of Life as Assessed by the National Eye Institute (NEI) Visual Function Questionnaire (VFQ) 25 (NEI-VFQ-25) - General Health Subscale
timeFrame: baseline
measure: Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - General Health Subscale
timeFrame: month 12
measure: Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - General Vision Subscale
timeFrame: baseline
measure: Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - General Vision Subscale
timeFrame: month 12
measure: Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Mental Health Subscale
timeFrame: baseline
measure: Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Mental Health Subscale
timeFrame: month 12
measure: Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Distance Activity Subscale
timeFrame: baseline
measure: Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Distance Activity Subscale
timeFrame: month 12
measure: Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Near Activity Subscale
timeFrame: baseline
measure: Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Near Activity Subscale
timeFrame: month 12
measure: Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Peripheral Vision Subscale
timeFrame: baseline
measure: Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Peripheral Vision Subscale
timeFrame: month 12
measure: Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Color Vision Subscale
timeFrame: baseline
measure: Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Color Vision Subscale
timeFrame: month 12
measure: Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Ocular Pain Subscale
timeFrame: baseline
measure: Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Ocular Pain Subscale
timeFrame: month 12
measure: Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Driving Subscale
timeFrame: baseline
measure: Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Driving Subscale
timeFrame: month 12
measure: Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Dependency Subscale
timeFrame: baseline
measure: Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Dependency Subscale
timeFrame: month 12
measure: Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Social Functioning Subscale
timeFrame: baseline
measure: Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Social Functioning Subscale
timeFrame: month 12
measure: Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Role Difficulty Subscale
timeFrame: baseline
measure: Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Role Difficulty Subscale
timeFrame: month 12
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego - Shiley Eye Institute
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Miami
country: United States
facility: Bascom Palmer Eye Institute - Miami
state: Florida
city: Palm Beach Gardens
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
city: Chicago
country: United States
facility: Northwestern University - Feinberg School of Medicine
state: Illinois
city: Overland Park
country: United States
facility: Stiles Eyecare Excellence and Glaucoma Institute
state: Kansas
city: Boston
country: United States
facility: New England Eye Center - Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts Eye and Ear Infirmary
state: Massachusetts
city: Chesterfield
country: United States
facility: Glaucoma Consultants of St. Louis
state: Missouri
city: Newark
country: United States
facility: Rutgers; New Jersey Medical School; IOVS
state: New Jersey
city: Rochelle Park
country: United States
facility: Glaucoma Institute of Northern NJ, LLC
state: New Jersey
city: New York
country: United States
facility: New York Eye and Ear Infirmary of Mount Sinai
state: New York
city: New York
country: United States
facility: Edward Harkness Eye Institute / Columbia University Medical Center
state: New York
city: Chapel Hill
country: United States
facility: UNC Kittner Eye Center
state: North Carolina
city: Portland
country: United States
facility: Devers Eye Institute/Legacy Health
state: Oregon
city: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Eye Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Eye Institute
state: Tennessee
city: Houston
country: United States
facility: Robert Cizik Eye Clinic
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Richmond
country: United States
facility: Virginia Eye Institute
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medicine Eye Institute
state: Washington
city: Morgantown
country: United States
facility: WVU Eye Institute
state: West Virginia
Study officials:
affiliation: Robert Cizik Eye Clinic
name: Robert Feldman, MD
role: STUDY_CHAIR
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citation: Francis BA, Kawji AS, Vo NT, Dustin L, Chopra V. Endoscopic cyclophotocoagulation (ECP) in the management of uncontrolled glaucoma with prior aqueous tube shunt. J Glaucoma. 2011 Oct;20(8):523-7. doi: 10.1097/IJG.0b013e3181f46337.
citation: Sood S, Beck AD. Cyclophotocoagulation versus sequential tube shunt as a secondary intervention following primary tube shunt failure in pediatric glaucoma. J AAPOS. 2009 Aug;13(4):379-83. doi: 10.1016/j.jaapos.2009.05.006.
citation: Schaefer JL, Levine MA, Martorana G, Koenigsman H, Smith MF, Sherwood MB. Failed glaucoma drainage implant: long-term outcomes of a second glaucoma drainage device versus cyclophotocoagulation. Br J Ophthalmol. 2015 Dec;99(12):1718-24. doi: 10.1136/bjophthalmol-2015-306725. Epub 2015 May 29.
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citation: Feldman RM, Chuang AZ, Mansberger SL, Tanna AP, Blieden LS, Bell NP, Gross RL, Pasquale LR, Greenfield DS, Liebmann JM, Weinreb RN; ASSISTS Group. Outcomes of the Second Aqueous Shunt Implant Versus Transscleral Cyclophotocoagulation Treatment Study: A Randomized Comparative Trial. J Glaucoma. 2022 Sep 1;31(9):701-709. doi: 10.1097/IJG.0000000000002079. Epub 2022 Jul 21.