MyoRing Implantation With Corneal Collagen Crosslinking for Keratoconus

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02590549

Enrollment

Registered

2015-10-29

Start date

2011-01-31

Completion date

2014-12-31

Last updated

2015-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus

Keywords

Keratoconus, riboflavin, corneal collagen crosslinking, intrasromal ring

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.

Interventions

PROCEDURECorneal 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,

DEVICEUfalink

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026