MyoRing Implantation With Corneal Collagen Crosslinking for Keratoconus

Brief Title

MyoRing Implantation With Corneal Collagen Crosslinking for Keratoconus

Official Title

Complete Corneal Ring (MyoRing) Implantation Combined With Corneal Collagen Crosslinking for Keratoconus

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.

Study Type

Interventional

Primary Outcome

K max

Secondary Outcome

 Visual acuity as assessed by Decimal system

Condition

Keratoconus

Intervention

Corneal Collagen Crosslinking

Study Arms / Comparison Groups

 MyoRing Implantation combined with corneal cross linking

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)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

Start Date

January 2011

Completion Date

December 2014

Primary Completion Date

December 2014

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.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Mukharram Bikbov, Professor, ,

Administrative Informations

NCT ID

NCT02590549

Organization ID

Myoring_CXL

Responsible Party

Sponsor

Study Sponsor

Ufa Eye Research Institute

Study Sponsor

Mukharram Bikbov, Professor, Study Chair, Ufa Eye Research Institute

Verification Date

October 2015