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Trabeculectomy Versus 2-iStent and Prostaglandin Study (TIPS)

Primary Purpose

Glaucoma, Open-Angle

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
iStent and travoprost or latanoprost
Trabeculectomy
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients who have mental capacity to give consent
  • Age >= 21 years
  • Pseudophakic or phakic without visually significant cataract
  • Open angle glaucoma
  • IOP in the range of 18-30 mmHg with 2 or more topical medications
  • Cup-disc ratio =< 0.9
  • Best corrected visual acuity of 20/100 or better

Exclusion Criteria:

  • Inability to give consent
  • Inability to tolerate or presence of allergy to prostaglandin analogs
  • Patient preference for non-surgical treatment or preference for either of the recommended surgical modalities in the study
  • Age < 21 years
  • Visually significant cataract that would benefit from cataract surgery, as determined by the treating surgeon in consultation with the patient
  • Secondary glaucoma or angle closure glaucoma
  • Aphakia
  • Prior glaucoma incisional surgery (trabeculectomy, tube surgery, other Microinvasive Glaucoma Surgery (MIGS) surgeries, deep sclerectomy)
  • Prior laser trabeculoplasty < 90 days prior to screening or absolute failure of prior laser trabeculoplasty.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    2 iStent with travoprost or latanoprost

    trabeculectomy

    Arm Description

    2 iStents will be injected into the trabecular meshwork and patients will be administered topical latanoprost or travoprost following surgery

    Standard trabeculectomy

    Outcomes

    Primary Outcome Measures

    IOP <= 18 mmHg
    IOP
    IOP <= 15 mmHg
    IOP
    IOP >= 20% reduction from untreated baseline
    IOP

    Secondary Outcome Measures

    Full Information

    First Posted
    September 5, 2017
    Last Updated
    January 17, 2018
    Sponsor
    Johns Hopkins University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03274323
    Brief Title
    Trabeculectomy Versus 2-iStent and Prostaglandin Study
    Acronym
    TIPS
    Official Title
    Trabeculectomy Versus 2-iStent and Prostaglandin Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Difficulty obtaining IDE by the FDA. Currently not worthwhile to pursue further.
    Study Start Date
    January 12, 2018 (Actual)
    Primary Completion Date
    January 12, 2018 (Actual)
    Study Completion Date
    January 12, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johns Hopkins University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Investigators hypothesize that the synergistic action of iStent in increasing aqueous outflow through the trabecular meshwork and use of prostaglandin analog such as travoprost or latanoprost to increase uveoscleral outflow will achieve good Intra-ocular Pressure (IOP) control with minimal complications in Primary Open Angle Glaucoma (POAG) patients with suboptimal IOP on 2 or more medications compared to mitomycin C (MMC) augmented trabeculectomy.
    Detailed Description
    This will be a prospective randomized controlled study. 20 phakic or pseudophakic open angle glaucoma patients with an IOP in the range of 18-30 mmHg on 2 or more topical glaucoma medications will be randomly selected to undergo either (1) mitomycin-augmented trabeculectomy or (2) placement of 2 iStent devices and initiation of a daily prostaglandin analog. This study is looking at the combined effects of the 2 iStents and a prostaglandin analog as a method to achieve low IOP. At 3 months (+/- 2 weeks) postoperatively, the iStent patients will be left only on the prostaglandin analog with a washout performed for any other hypotensive medication used. Patients who had a trabeculectomy will be have a terminal washout of all IOP-lowering medications at 3 months (+/- 2 weeks) post-surgery. The IOP will then be measured for both groups at 4 months (+/- 3 weeks) postoperatively.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma, Open-Angle

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    2 iStent with travoprost or latanoprost
    Arm Type
    Experimental
    Arm Description
    2 iStents will be injected into the trabecular meshwork and patients will be administered topical latanoprost or travoprost following surgery
    Arm Title
    trabeculectomy
    Arm Type
    Active Comparator
    Arm Description
    Standard trabeculectomy
    Intervention Type
    Device
    Intervention Name(s)
    iStent and travoprost or latanoprost
    Intervention Description
    2 iStents will be inserted and patients will be started on travoprost or latanoprost following the procedure
    Intervention Type
    Procedure
    Intervention Name(s)
    Trabeculectomy
    Intervention Description
    Standard trabeculectomy
    Primary Outcome Measure Information:
    Title
    IOP <= 18 mmHg
    Description
    IOP
    Time Frame
    Post surgery month 4
    Title
    IOP <= 15 mmHg
    Description
    IOP
    Time Frame
    Post surgery month 4
    Title
    IOP >= 20% reduction from untreated baseline
    Description
    IOP
    Time Frame
    Post surgery month 4

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients who have mental capacity to give consent Age >= 21 years Pseudophakic or phakic without visually significant cataract Open angle glaucoma IOP in the range of 18-30 mmHg with 2 or more topical medications Cup-disc ratio =< 0.9 Best corrected visual acuity of 20/100 or better Exclusion Criteria: Inability to give consent Inability to tolerate or presence of allergy to prostaglandin analogs Patient preference for non-surgical treatment or preference for either of the recommended surgical modalities in the study Age < 21 years Visually significant cataract that would benefit from cataract surgery, as determined by the treating surgeon in consultation with the patient Secondary glaucoma or angle closure glaucoma Aphakia Prior glaucoma incisional surgery (trabeculectomy, tube surgery, other Microinvasive Glaucoma Surgery (MIGS) surgeries, deep sclerectomy) Prior laser trabeculoplasty < 90 days prior to screening or absolute failure of prior laser trabeculoplasty.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Trabeculectomy Versus 2-iStent and Prostaglandin Study

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