Clinical Trials Directory

Trials / Completed

CompletedNCT02590549

MyoRing Implantation With Corneal Collagen Crosslinking for Keratoconus

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
16 (actual)
Sponsor
Ufa Eye Research Institute · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURECorneal Collagen CrosslinkingSterile 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,
DEVICEUfalinkUVA irradiation with wave length 370 nm, 3 mW/cm2 is provided with UFalink, device,Russian Federation

Timeline

Start date
2011-01-01
Primary completion
2014-12-01
Completion
2014-12-01
First posted
2015-10-29
Last updated
2015-10-29

Source: ClinicalTrials.gov record NCT02590549. Inclusion in this directory is not an endorsement.