MyoRing Implantation With Corneal Collagen Crosslinking for Keratoconus

Ufa Eye Research Institute

Status: Completed

Conditions: Keratoconus

Treatments: Device: Ufalink; Procedure: Corneal Collagen Crosslinking

Study type: Interventional

Funder types: Other

Identifiers

NCT02590549

Myoring_CXL

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

MyoRing Implantation combined with corneal cross linking

Experimental group

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)

Treatment:

Device: Ufalink

Procedure: Corneal Collagen Crosslinking