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

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ClinicalTrials.gov Identifier: NCT02691455
Recruitment Status : Enrolling by invitation
First Posted : February 25, 2016
Last Update Posted : February 18, 2019
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)
Estimated Enrollment : 280 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
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

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. Compare cumulative incidences of failures [ Time Frame: 5 years ]
    Compare cumulative incidences of failures in participants who undergo a second aqueous shunt (SAS) to those cumulative incidences of failures who undergo transscleral diode laser cyclophotocoagulation (TLC) for eyes with uncontrolled glaucoma with a single existing aqueous shunt implant.

  2. Compare cumulative incidences of failures [ Time Frame: 1 year ]
    Compare cumulative incidences of failures in participants who undergo a second aqueous shunt (SAS) to those cumulative incidences of failures who undergo transscleral diode laser cyclophotocoagulation (TLC) for eyes with uncontrolled glaucoma with a single existing aqueous shunt implant.

  3. Compare cumulative incidences of failures [ Time Frame: 3 years ]
    Compare cumulative incidences of failures in participants who undergo a second aqueous shunt (SAS) to those cumulative incidences of failures who undergo transscleral diode laser cyclophotocoagulation (TLC) for eyes with uncontrolled glaucoma with a single existing aqueous shunt implant.


Secondary Outcome Measures :
  1. Cumulative incidence of vision-threatening complications [ Time Frame: 5 years ]
    Cumulative incidence of vision-threatening complications

  2. Incidence of eyes that lose more than two lines of vision [ Time Frame: 5 years ]
    Incidence of eyes that lose more than two lines of vision

  3. Incidence of pain [ Time Frame: 1 week, 1 month ]
    Assessed by the Universal Pain Assessment Tool

  4. Total number of visits [ Time Frame: 3 months, 1 year, 5 years ]
    Total number of visits

  5. Changes in vision-related quality of life assessed by NEI VFQ-25 [ Time Frame: 1 year, 3 years, 5 years ]
    Changes in vision-related quality of life assessed by National Eye Institute Visual Functioning Questionnaire - 25 (NEI VFQ-25)

  6. Severity of pain [ Time Frame: 1 week, 1 month ]
    Assessed by the Universal Pain Assessment Tool



Information from the National Library of Medicine

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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


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Sponsors and Collaborators
Robert Feldman
Investigators
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Study Chair: Robert Feldman, MD Robert Cizik Eye Clinic

Publications:

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Responsible Party: Robert Feldman, M.D., The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02691455     History of Changes
Other Study ID Numbers: HSC-MS-15-1053
First Posted: February 25, 2016    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
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.