NCT02590549

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2015

Completed
Last Updated

October 29, 2015

Status Verified

October 1, 2015

Enrollment Period

3.9 years

First QC Date

October 25, 2015

Last Update Submit

October 28, 2015

Conditions

Keratoconus

Keywords

Keratoconusriboflavincorneal collagen crosslinkingintrasromal ring

Outcome Measures

Primary Outcomes (1)

  • K max

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

    2 years

Secondary Outcomes (1)

  • Visual acuity as assessed by Decimal system

    2 years

Study Arms (1)

MyoRing Implantation combined with corneal cross linking

EXPERIMENTAL

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)

Procedure: Corneal Collagen CrosslinkingDevice: Ufalink

Interventions

Corneal Collagen CrosslinkingPROCEDURE

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,

MyoRing Implantation combined with corneal cross linking
UfalinkDEVICE

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

MyoRing Implantation combined with corneal cross linking

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>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)

You may not qualify if:

  • minimal pachymetry of less than 380 μm,
  • a history of previous ocular pathology or ocular surgery;
  • pregnancy or breastfeeding;
  • corneal scarring.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Jadidi K, Mosavi SA, Nejat F, Naderi M, Janani L, Serahati S. Intrastromal corneal ring segment implantation (keraring 355 degrees ) in patients with central keratoconus: 6-month follow-up. J Ophthalmol. 2015;2015:916385. doi: 10.1155/2015/916385. Epub 2015 Jan 5.

    PMID: 25685395BACKGROUND

MeSH Terms

Conditions

Keratoconus

Interventions

Corneal Cross-Linking

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

PhotochemotherapyCombined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Officials

  • Mukharram Bikbov, Professor

    Ufa Eye Research Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2015

First Posted

October 29, 2015

Study Start

January 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

October 29, 2015

Record last verified: 2015-10