The American Glaucoma Society (AGS) Second Aqueous Shunt Implant vs. Transscleral Cyclophotocoagulation Treatment Study (ASSISTS) (ASSISTS)
October 26, 2021 updated by: Robert Feldman
The AGS Second Aqueous Shunt Implant vs. Transscleral Cyclophotocoagulation Treatment Study
Outcomes of subjects with uncontrolled glaucoma with a single existing aqueous tube shunt implant undergoing a second aqueous shunt to transscleral diode laser cyclophotocoagulation.
Study Overview
Status
Terminated
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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La Jolla, California, United States, 92093
- University of California San Diego - Shiley Eye Institute
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Los Angeles, California, United States, 90033
- University of Southern California
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Florida
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Miami, Florida, United States, 33136
- Bascom Palmer Eye Institute - Miami
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Palm Beach Gardens, Florida, United States, 33418
- Bascom Palmer Eye Institute
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University - Feinberg School of Medicine
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Kansas
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Overland Park, Kansas, United States, 66213
- Stiles Eyecare Excellence and Glaucoma Institute
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts Eye and Ear Infirmary
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Boston, Massachusetts, United States, 02111
- New England Eye Center - Tufts Medical Center
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Missouri
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Chesterfield, Missouri, United States, 63017
- Glaucoma Consultants of St. Louis
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New Jersey
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Newark, New Jersey, United States, 07103
- Rutgers; New Jersey Medical School; IOVS
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Rochelle Park, New Jersey, United States, 07062
- Glaucoma Institute of Northern NJ, LLC
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New York
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New York, New York, United States, 10003
- New York Eye and Ear Infirmary of Mount Sinai
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New York, New York, United States, 10032
- Edward Harkness Eye Institute / Columbia University Medical Center
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North Carolina
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Chapel Hill, North Carolina, United States, 27517
- UNC Kittner Eye Center
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Oregon
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Portland, Oregon, United States, 97210
- Devers Eye Institute/Legacy Health
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Wills Eye Hospital
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Pittsburgh, Pennsylvania, United States, 15213
- UPMC Eye Center
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt Eye Institute
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Texas
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Houston, Texas, United States, 77030
- Robert Cizik Eye Clinic
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Virginia
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Charlottesville, Virginia, United States, 22903
- University of Virginia Health System
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Richmond, Virginia, United States, 23226
- Virginia Eye Institute
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Washington
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Seattle, Washington, United States, 98104
- University of Washington Medicine Eye Institute
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West Virginia
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Morgantown, West Virginia, United States, 26506
- WVU Eye Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Second Aqueous Shunt
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. |
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Active Comparator: Transscleral Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of Eyes That Failed Treatment
Time Frame: from time of intervention to month 6
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Treatment failure is defined as meeting one or more of the following 4 criteria:
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from time of intervention to month 6
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Number of Eyes That Failed Treatment
Time Frame: from month 6 to month 12
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Treatment failure is defined as meeting one or more of the following 4 criteria:
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from month 6 to month 12
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Number of Eyes That Failed Treatment
Time Frame: from month 12 to year 3
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Treatment failure is defined as meeting one or more of the following 4 criteria:
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from month 12 to year 3
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of Eyes With Vision-threatening Complications
Time Frame: from the time of intervention to year 3
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from the time of intervention to year 3
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Number of Eyes That Lost Two or More Lines of Vision as Assessed by the Snellen Chart Visual Acuity Test
Time Frame: from time of intervention to year 3
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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.
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from time of intervention to year 3
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Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
Time Frame: baseline, week 1
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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).
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baseline, week 1
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Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
Time Frame: baseline, month 1
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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).
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baseline, month 1
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Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
Time Frame: baseline, month 3
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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).
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baseline, month 3
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Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
Time Frame: baseline, month 6
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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).
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baseline, month 6
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Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
Time Frame: baseline, month 12
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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).
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baseline, month 12
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Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
Time Frame: baseline, year 2
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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).
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baseline, year 2
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Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
Time Frame: baseline, year 3
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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).
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baseline, year 3
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Incidence of Pain
Time Frame: 1 week
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Number of participants who reported pain.
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1 week
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Incidence of Pain
Time Frame: 1 month
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Number of participants who reported pain.
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1 month
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Severity of Pain
Time Frame: 1 week
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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.
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1 week
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Severity of Pain
Time Frame: 1 month
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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.
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1 month
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Number of Office Visits Per Participant From Baseline to 3 Months
Time Frame: from baseline to 3 months
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from baseline to 3 months
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Number of Office Visits Per Participant Per Month After Month 3
Time Frame: from month 4 to year 3
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from month 4 to year 3
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Vision-related Quality of Life as Assessed by the National Eye Institute (NEI) Visual Function Questionnaire (VFQ) 25 (NEI-VFQ-25) - General Health Subscale
Time Frame: baseline
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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.
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baseline
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Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - General Health Subscale
Time Frame: month 12
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The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
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month 12
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Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - General Vision Subscale
Time Frame: baseline
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The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
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baseline
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Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - General Vision Subscale
Time Frame: month 12
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The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
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month 12
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Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Mental Health Subscale
Time Frame: baseline
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The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
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baseline
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Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Mental Health Subscale
Time Frame: month 12
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The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
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month 12
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Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Distance Activity Subscale
Time Frame: baseline
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The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
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baseline
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Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Distance Activity Subscale
Time Frame: month 12
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The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
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month 12
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Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Near Activity Subscale
Time Frame: baseline
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The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
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baseline
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Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Near Activity Subscale
Time Frame: month 12
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The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
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month 12
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Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Peripheral Vision Subscale
Time Frame: baseline
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The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
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baseline
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Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Peripheral Vision Subscale
Time Frame: month 12
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The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
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month 12
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Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Color Vision Subscale
Time Frame: baseline
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The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
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baseline
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Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Color Vision Subscale
Time Frame: month 12
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The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
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month 12
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Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Ocular Pain Subscale
Time Frame: baseline
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The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
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baseline
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Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Ocular Pain Subscale
Time Frame: month 12
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The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
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month 12
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Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Driving Subscale
Time Frame: baseline
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The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
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baseline
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Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Driving Subscale
Time Frame: month 12
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The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
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month 12
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Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Dependency Subscale
Time Frame: baseline
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The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
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baseline
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Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Dependency Subscale
Time Frame: month 12
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The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
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month 12
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Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Social Functioning Subscale
Time Frame: baseline
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The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
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baseline
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Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Social Functioning Subscale
Time Frame: month 12
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The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
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month 12
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Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Role Difficulty Subscale
Time Frame: baseline
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The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
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baseline
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Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Role Difficulty Subscale
Time Frame: month 12
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The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
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month 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Robert Feldman, MD, Robert Cizik Eye Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gedde SJ, Schiffman JC, Feuer WJ, Herndon LW, Brandt JD, Budenz DL; Tube versus Trabeculectomy Study Group. Treatment outcomes in the Tube Versus Trabeculectomy (TVT) study after five years of follow-up. Am J Ophthalmol. 2012 May;153(5):789-803.e2. doi: 10.1016/j.ajo.2011.10.026. Epub 2012 Jan 15.
- Arora KS, Robin AL, Corcoran KJ, Corcoran SL, Ramulu PY. Use of Various Glaucoma Surgeries and Procedures in Medicare Beneficiaries from 1994 to 2012. Ophthalmology. 2015 Aug;122(8):1615-24. doi: 10.1016/j.ophtha.2015.04.015. Epub 2015 Jun 16.
- Budenz DL, Barton K, Gedde SJ, Feuer WJ, Schiffman J, Costa VP, Godfrey DG, Buys YM; Ahmed Baerveldt Comparison Study Group. Five-year treatment outcomes in the Ahmed Baerveldt comparison study. Ophthalmology. 2015 Feb;122(2):308-16. doi: 10.1016/j.ophtha.2014.08.043. Epub 2014 Oct 17.
- Anand A, Tello C, Sidoti PA, Ritch R, Liebmann JM. Sequential glaucoma implants in refractory glaucoma. Am J Ophthalmol. 2010 Jan;149(1):95-101. doi: 10.1016/j.ajo.2009.07.019. Epub 2009 Oct 17.
- Burgoyne JK, WuDunn D, Lakhani V, Cantor LB. Outcomes of sequential tube shunts in complicated glaucoma. Ophthalmology. 2000 Feb;107(2):309-14. doi: 10.1016/s0161-6420(99)00039-1.
- Ness PJ, Khaimi MA, Feldman RM, Tabet R, Sarkisian SR Jr, Skuta GL, Chuang AZ, Mankiewicz KA. Intermediate term safety and efficacy of transscleral cyclophotocoagulation after tube shunt failure. J Glaucoma. 2012 Feb;21(2):83-8. doi: 10.1097/IJG.0b013e31820bd1ce.
- Jimenez-Roman J, Gil-Carrasco F, Costa VP, Schimiti RB, Lerner F, Santana PR, Vascocellos JP, Castillejos-Chevez A, Turati M, Fabre-Miranda K. Intraocular pressure control after the implantation of a second Ahmed glaucoma valve. Int Ophthalmol. 2016 Jun;36(3):347-53. doi: 10.1007/s10792-015-0125-z. Epub 2015 Sep 3.
- Semchyshyn TM, Tsai JC, Joos KM. Supplemental transscleral diode laser cyclophotocoagulation after aqueous shunt placement in refractory glaucoma. Ophthalmology. 2002 Jun;109(6):1078-84. doi: 10.1016/s0161-6420(02)01019-9.
- Smith M, Buys YM, Trope GE. Second Ahmed valve insertion in the same eye. J Glaucoma. 2009 Apr-May;18(4):336-40. doi: 10.1097/IJG.0b013e318182edfb.
- Godfrey DG, Krishna R, Greenfield DS, Budenz DL, Gedde SJ, Scott IU. Implantation of second glaucoma drainage devices after failure of primary devices. Ophthalmic Surg Lasers. 2002 Jan-Feb;33(1):37-43.
- Ko SJ, Hwang YH, Ahn SI, Kim HK. Surgical Outcomes of Additional Ahmed Glaucoma Valve Implantation in Refractory Glaucoma. J Glaucoma. 2016 Jun;25(6):e620-4. doi: 10.1097/IJG.0000000000000298.
- 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.
- 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.
- 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.
- Gabelt BT, Kaufman PL. Changes in aqueous humor dynamics with age and glaucoma. Prog Retin Eye Res. 2005 Sep;24(5):612-37. doi: 10.1016/j.preteyeres.2004.10.003.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2016
Primary Completion (Actual)
September 30, 2020
Study Completion (Actual)
September 30, 2020
Study Registration Dates
First Submitted
February 15, 2016
First Submitted That Met QC Criteria
February 21, 2016
First Posted (Estimate)
February 25, 2016
Study Record Updates
Last Update Posted (Actual)
November 2, 2021
Last Update Submitted That Met QC Criteria
October 26, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-MS-15-1053
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
To the American Glaucoma Society members after completion of the study, with an institutional review board (IRB) approved protocol.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.