MyoRing Implantation With Corneal Collagen Crosslinking for Keratoconus

Keratoconus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02590549
• Other study ID #: Myoring_CXL
• Status: Completed
• Phase: N/A
• First received: October 25, 2015
• Last updated: October 28, 2015
• Start date: January 2011
• Est. completion date: December 2014

Study information

• Verified date: October 2015
• Source: Ufa Eye Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Keratoconus

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ufa Eye Research Institute

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	K max	Using topography measurements, decrease of maximum keratometry value over the preoperative maximum keratometry value	2 years	Yes
Secondary	Visual acuity as assessed by Decimal system	Decimal visual acuity assessed on a study later was converted to the logarithm of minimal angle of resolution (logMAR).	2 years	Yes