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MyoRing Implantation With Corneal Collagen Crosslinking for Keratoconus

NCT02590549 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2015-10-29

No results posted yet for this study

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

  • Keratoconus

Interventions

PROCEDURE

Corneal 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,

DEVICE

Ufalink

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

Sponsors & Collaborators

  • Ufa Eye Research Institute

    lead OTHER

Principal Investigators

  • Mukharram Bikbov, Professor · Ufa Eye Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2014-12-31
Completion
2014-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02590549 on ClinicalTrials.gov