MyoRing Implantation With Corneal Collagen Crosslinking for Keratoconus

October 28, 2015 updated by: Ufa Eye Research Institute

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MyoRing Implantation combined with corneal cross linking
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)
Procedure: Corneal Collagen Crosslinking

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,

Device: Ufalink
UVA irradiation with wave length 370 nm, 3 mW/cm2 is provided with UFalink, device,Russian Federation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
K max
Time Frame: 2 years
Using topography measurements, decrease of maximum keratometry value over the preoperative maximum keratometry value
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity as assessed by Decimal system
Time Frame: 2 years
Decimal visual acuity assessed on a study later was converted to the logarithm of minimal angle of resolution (logMAR).
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ufa Eye Research Institute

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

October 25, 2015

First Submitted That Met QC Criteria

October 28, 2015

First Posted (Estimate)

October 29, 2015

Study Record Updates

Last Update Posted (Estimate)

October 29, 2015

Last Update Submitted That Met QC Criteria

October 28, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Myoring_CXL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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