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INTACS (Intrastromal Corneal Ring Segments) For Corneal Ectasia (INTACS)

Primary Purpose

Keratoconus

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
INTACS
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus

Eligibility Criteria

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

Inclusion Criteria:

  • 21 years of age, or older
  • have experienced a progressive deterioration in their vision, such that they can no longer achieve adequate functional vision on a daily basis with contact lenses, or spectacles.
  • have clear central corneas
  • have a corneal thickness of 450 microns or greater at the proposed incision site
  • have corneal transplantation as the only remaining option to improve their visual function

Exclusion Criteria:

  • under 21 years of age
  • have not experienced a progressive deterioration in their vision, such that they can no longer achieve adequate functional vision on a daily basis with contact lenses, or spectacles.
  • do not have clear central corneas
  • do not have a corneal thickness of 450 microns or greater at the proposed incision site
  • do not have corneal transplantation as the only remaining option to improve their visual function

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Keratoconus

    Arm Description

    Outcomes

    Primary Outcome Measures

    Corneal mapping to measure corneal thickness and steepening
    Corneal Topography

    Secondary Outcome Measures

    Full Information

    First Posted
    July 29, 2015
    Last Updated
    June 2, 2023
    Sponsor
    University of California, San Diego
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02512432
    Brief Title
    INTACS (Intrastromal Corneal Ring Segments) For Corneal Ectasia
    Acronym
    INTACS
    Official Title
    INTACS (Intrastromal Corneal Ring Segments) For Corneal Ectasia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    June 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, San Diego

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To join established study put on by Addition Technologies, Inc. in the surgical implantation of asymmetrical INTACS segments to treat myopia and astigmatism in patients with keratoconus.
    Detailed Description
    Use of asymmetrical corneal inserts to reduce or eliminate myopia and astigmatism in patients with keratoconus, who are no longer able to achieve adequate vision with their contact lenses or spectacles, so that their functional vision may be restored and the need for corneal transplantation may potentially be deferred.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Keratoconus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    1000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Keratoconus
    Arm Type
    Other
    Intervention Type
    Device
    Intervention Name(s)
    INTACS
    Intervention Description
    asymmetrical corneal inserts to reduce, or eliminate myopia and astigmatism in patients with keratoconus to decrease dependence on contact lenses and spectacle correction, while potentially deferring need for corneal transplantation.
    Primary Outcome Measure Information:
    Title
    Corneal mapping to measure corneal thickness and steepening
    Description
    Corneal Topography
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 21 years of age, or older have experienced a progressive deterioration in their vision, such that they can no longer achieve adequate functional vision on a daily basis with contact lenses, or spectacles. have clear central corneas have a corneal thickness of 450 microns or greater at the proposed incision site have corneal transplantation as the only remaining option to improve their visual function Exclusion Criteria: under 21 years of age have not experienced a progressive deterioration in their vision, such that they can no longer achieve adequate functional vision on a daily basis with contact lenses, or spectacles. do not have clear central corneas do not have a corneal thickness of 450 microns or greater at the proposed incision site do not have corneal transplantation as the only remaining option to improve their visual function
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Onnie Parker
    Phone
    8588224848
    Email
    oparker@ucsd.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christopher Heichel, MD
    Organizational Affiliation
    University of California, San Diego, Shiley Eye Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    INTACS (Intrastromal Corneal Ring Segments) For Corneal Ectasia

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