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MyoRing Implantation With Corneal Collagen Crosslinking for Keratoconus

Primary Purpose

Keratoconus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Corneal Collagen Crosslinking
Ufalink
Sponsored by
Ufa Eye Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring Keratoconus, riboflavin, corneal collagen crosslinking, intrasromal ring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • >18 years old
  • a diagnosis of keratoconus, intolerance for contact lenses or glasses
  • a documented progression of disease. This progression was defined by the following changes over 1 year: an increase of the steepest K by 1.0 diopter (D) or more in manifest cylinder, or an increase of 0.5 D or more in manifest spherical equivalent (SE) refraction by repeated keratotopography ODP-scan ARK-1000 (Nidek, Japan)

Exclusion Criteria:

  • minimal pachymetry of less than 380 μm,
  • a history of previous ocular pathology or ocular surgery;
  • pregnancy or breastfeeding;
  • corneal scarring.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    MyoRing Implantation combined with corneal cross linking

    Arm Description

    Surgical technique: Implantation of a MyoRing in a corneal pocket was performed by using a PocketMaker microkeratome a guided, vibrating diamond blade to create a stromal pocket 9 mm in diameter at a 300-μm depth via a 4- to 5-mm-wide corneal tunnel followed by Corneal Collagen Crosslinking (standard surface UVA irradiation (370 nm, 3 mW/cm2) using Ufalink device)

    Outcomes

    Primary Outcome Measures

    K max
    Using topography measurements, decrease of maximum keratometry value over the preoperative maximum keratometry value

    Secondary Outcome Measures

    Visual acuity as assessed by Decimal system
    Decimal visual acuity assessed on a study later was converted to the logarithm of minimal angle of resolution (logMAR).

    Full Information

    First Posted
    October 25, 2015
    Last Updated
    October 28, 2015
    Sponsor
    Ufa Eye Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02590549
    Brief Title
    MyoRing Implantation With Corneal Collagen Crosslinking for Keratoconus
    Official Title
    Complete Corneal Ring (MyoRing) Implantation Combined With Corneal Collagen Crosslinking for Keratoconus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2011 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ufa Eye Research Institute

    4. Oversight

    5. Study Description

    Brief Summary
    A complete intrastromal ring, MyoRing (Dioptex, GmbH, Linz, Austria), suggested by Albert Daxer in 2007, is a relatively new technique that has been demonstrated to treat keratoconus safely and effectively.Corneal collagen crosslinking (CXL), introduced by Wollensak et al. in 2003, has become a standard treatment for progressive keratoconus to slow or possibly stop progression of disease. The formation of the stromal pocket during MyoRing implantation offers the opportunity for simultaneous introduction of riboflavin 0.1% into the pocket followed by UVA irradiation to provide combined treatment in patients with progressive keratoconus.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Keratoconus
    Keywords
    Keratoconus, riboflavin, corneal collagen crosslinking, intrasromal ring

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    MyoRing Implantation combined with corneal cross linking
    Arm Type
    Experimental
    Arm Description
    Surgical technique: Implantation of a MyoRing in a corneal pocket was performed by using a PocketMaker microkeratome a guided, vibrating diamond blade to create a stromal pocket 9 mm in diameter at a 300-μm depth via a 4- to 5-mm-wide corneal tunnel followed by Corneal Collagen Crosslinking (standard surface UVA irradiation (370 nm, 3 mW/cm2) using Ufalink device)
    Intervention Type
    Procedure
    Intervention Name(s)
    Corneal Collagen Crosslinking
    Intervention Description
    Sterile riboflavin solution 0.1% was then continuously injected for 3 minutes into the corneal pocket via a standard 0.3-mm cannula through the incision tunnel. Standard surface UVA irradiation (370 nm, 3 mW/cm2) was then applied at a 5-cm distance for 30 minutes. After UVA irradiation, a flexible MyoRing intracorneal implant was inserted into the corneal pocket,
    Intervention Type
    Device
    Intervention Name(s)
    Ufalink
    Intervention Description
    UVA irradiation with wave length 370 nm, 3 mW/cm2 is provided with UFalink, device,Russian Federation
    Primary Outcome Measure Information:
    Title
    K max
    Description
    Using topography measurements, decrease of maximum keratometry value over the preoperative maximum keratometry value
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Visual acuity as assessed by Decimal system
    Description
    Decimal visual acuity assessed on a study later was converted to the logarithm of minimal angle of resolution (logMAR).
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: >18 years old a diagnosis of keratoconus, intolerance for contact lenses or glasses a documented progression of disease. This progression was defined by the following changes over 1 year: an increase of the steepest K by 1.0 diopter (D) or more in manifest cylinder, or an increase of 0.5 D or more in manifest spherical equivalent (SE) refraction by repeated keratotopography ODP-scan ARK-1000 (Nidek, Japan) Exclusion Criteria: minimal pachymetry of less than 380 μm, a history of previous ocular pathology or ocular surgery; pregnancy or breastfeeding; corneal scarring.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mukharram Bikbov, Professor
    Organizational Affiliation
    Ufa Eye Research Institute
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25685395
    Citation
    Jadidi K, Mosavi SA, Nejat F, Naderi M, Janani L, Serahati S. Intrastromal corneal ring segment implantation (keraring 355 degrees ) in patients with central keratoconus: 6-month follow-up. J Ophthalmol. 2015;2015:916385. doi: 10.1155/2015/916385. Epub 2015 Jan 5.
    Results Reference
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    MyoRing Implantation With Corneal Collagen Crosslinking for Keratoconus

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