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

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ClinicalTrials.gov Identifier: NCT02691455
Recruitment Status : Terminated (Difficulty in recruiting participants)
First Posted : February 25, 2016
Results First Posted : October 14, 2021
Last Update Posted : October 14, 2021
Sponsor:
Information provided by (Responsible Party):
Robert Feldman, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Glaucoma Device: Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Procedure: Transscleral Diode Laser Cyclophotocoagulation Device: Ahmed Model FP7 Flexible Plate Device: Baerveldt Glaucoma Implant 250-mm2 / BG103-250 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The AGS Second Aqueous Shunt Implant vs. Transscleral Cyclophotocoagulation Treatment Study
Actual Study Start Date : February 2016
Actual Primary Completion Date : September 30, 2020
Actual Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
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.

Device: Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Device: Ahmed Model FP7 Flexible Plate
Device: Baerveldt Glaucoma Implant 250-mm2 / BG103-250
Active Comparator: Transscleral Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation
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.
Other Name: Transscleral Diode Laser Cyclophotocoagulation (TLC)




Primary Outcome Measures :
  1. Number of Eyes That Failed Treatment [ Time Frame: from time of intervention to month 6 ]

    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).

  2. Number of Eyes That Failed Treatment [ Time Frame: from month 6 to month 12 ]

    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).

  3. Number of Eyes That Failed Treatment [ Time Frame: from month 12 to year 3 ]

    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).


Secondary Outcome Measures :
  1. Number of Eyes With Vision-threatening Complications [ Time Frame: from the time of intervention to year 3 ]
  2. 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 ]
    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.

  3. Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test [ Time Frame: baseline, week 1 ]
    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).

  4. Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test [ Time Frame: baseline, month 1 ]
    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).

  5. Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test [ Time Frame: baseline, month 3 ]
    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).

  6. Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test [ Time Frame: baseline, month 6 ]
    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).

  7. Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test [ Time Frame: baseline, month 12 ]
    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).

  8. Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test [ Time Frame: baseline, year 2 ]
    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).

  9. Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test [ Time Frame: baseline, year 3 ]
    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).

  10. Incidence of Pain [ Time Frame: 1 week ]
    Number of participants who reported pain.

  11. Incidence of Pain [ Time Frame: 1 month ]
    Number of participants who reported pain.

  12. Severity of Pain [ Time Frame: 1 week ]
    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.

  13. Severity of Pain [ Time Frame: 1 month ]
    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.

  14. Number of Office Visits Per Participant From Baseline to 3 Months [ Time Frame: from baseline to 3 months ]
  15. Number of Office Visits Per Participant Per Month After Month 3 [ Time Frame: from month 4 to year 3 ]
  16. 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 ]
    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.

  17. 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 ]
    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.

  18. 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 ]
    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.

  19. 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 ]
    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.

  20. 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 ]
    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.

  21. 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 ]
    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.

  22. 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 ]
    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.

  23. 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 ]
    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.

  24. 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 ]
    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.

  25. 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 ]
    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.

  26. 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 ]
    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.

  27. 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 ]
    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.

  28. 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 ]
    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.

  29. 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 ]
    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.

  30. 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 ]
    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.

  31. 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 ]
    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.

  32. Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Driving Subscale [ Time Frame: baseline ]
    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.

  33. 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 ]
    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.

  34. Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Dependency Subscale [ Time Frame: baseline ]
    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.

  35. 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 ]
    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.

  36. 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 ]
    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.

  37. 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 ]
    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.

  38. 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 ]
    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.

  39. 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 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02691455


Locations
Show Show 23 study locations
Sponsors and Collaborators
Robert Feldman
Investigators
Layout table for investigator information
Study Chair: Robert Feldman, MD Robert Cizik Eye Clinic
  Study Documents (Full-Text)

Documents provided by Robert Feldman, The University of Texas Health Science Center, Houston:
Publications:

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Responsible Party: Robert Feldman, M.D., The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02691455    
Other Study ID Numbers: HSC-MS-15-1053
First Posted: February 25, 2016    Key Record Dates
Results First Posted: October 14, 2021
Last Update Posted: October 14, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: To the American Glaucoma Society members after completion of the study, with an institutional review board (IRB) approved protocol.
Additional relevant MeSH terms:
Layout table for MeSH terms
Glaucoma
Ocular Hypertension
Eye Diseases