MyoRing Implantation With Corneal Collagen Crosslinking for Keratoconus

Not Applicable

Completed

• Conditions: Keratoconus
• Interventions: Procedure: Corneal Collagen Crosslinking; Device: Ufalink

• Registration Number: NCT02590549
• Lead Sponsor: Ufa Eye Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-10
• Study First Submitted: 2015-10-25
• Study First Submitted QC: 2015-10-28
• Last Update Submitted: 2015-10-28
• Study First Posted: 2015-10-29
• Last Update Posted: 2015-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MyoRing Implantation combined with corneal cross linking	Ufalink	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)
MyoRing Implantation combined with corneal cross linking	Corneal Collagen Crosslinking	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)

Primary Outcome Measures

Name	Time	Method
K max	2 years	Using topography measurements, decrease of maximum keratometry value over the preoperative maximum keratometry value

Secondary Outcome Measures

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