MyoRing Implantation 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.

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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Corneal collagen crosslinking

Procedure

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,

Ufalink

Device

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

Primary outcomes

K max

Time frame: 2 years

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

Secondary outcomes

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).

Sponsors and collaborators

Lead sponsor

Ufa Eye Research Institute

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Oct 29, 2015
Registry last updated: Oct 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed