Laser In-situ Keratomileusis With Crosslinking Compared to Conventional LASIK in Patients With High Myopia

A Controlled Evaluation of the Safety and Efficacy of Laser In-situ Keratomileusis With Crosslinking (XtraLASIK) Compared to Conventional LASIK (convLASIK) in Patients With High Myopia

The objectives of this study are to evaluate the safety and efficacy of a treatment regimen for high myopia and myopic astigmatism: LASIK followed by crosslinking performed with the KXL Crosslinking-System and VibeX Xtra (Riboflavin Ophthalmic Solution, Avedro, USA), as compared to LASIK alone, with regards to regression of refractive outcome, as measured by manifest refraction spherical equivalent (MRSE) and keratometry.

Study Overview

• Status: Completed
• Conditions: Myopia; Corneal Ectasia; Myopic Astigmatism; Crosslinking; Myopic Regression
• Intervention / Treatment: Procedure: LasikXtra; Procedure: LASIK

Detailed Description

This is a controlled study of the safety and efficacy of the KXL System and VibeX Xtra (Riboflavin Ophthalmic Solution, Avedro, USA) for performing crosslinking in eyes undergoing LASIK for high myopia or myopic astigmatism. Each subject will have bilateral LASIK performed and one eye will be randomized to undergo LASIK followed by crosslinking.

Subjects will undergo bilateral LASIK. Following randomisation one eye of each subject will be treated with VibeX Xtra (Riboflavin Ophthalmic Solution) following LASIK and will be irradiated with the KXL System at 30 mW/cm2 intensity for 90 seconds continuous UV-A light treatment for a total radiant exposure of 2.7 J /cm2.

All eyes will be assessed at 1 day, 1, 3, 6, and 12 months after treatment.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Frankfurt am Main, Hessen, Germany, 60590
      • Department of ophthalmology University clinic Frankfurt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• eligible for bilateral myopic fs-LASIK with -6.00 to -12.00 D (diopters) with a maximum of 5.00 D astigmatism
• age > 18 years
• provided written informed consent
• difference between the MRSE and cycloplegic SE less than 0.75 D
• MRSE needed to be stable for the last 12 months (<0.5 D).

Exclusion Criteria:

• prior corneal surgery,
• forme fruste or manifest keratoconus,
• history of corneal scarring, melting, ulceration
• repeating inflammations of the eye
• taking vitamin C 1 week prior to the treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Study group; LASIK followed by intraoperative application of riboflavin under the flap and crosslinking after reposition of the flap.	Procedure: LasikXtra; By randomized selection, one eye was treated with the LASIK Xtra procedure that consists of fs-LASIK treatment combined with intraoperative accelerated continuous UV-riboflavin crosslinking. After laser ablation, the corneal bed under the flap was coated with riboflavin, rinsed with saline solution, and after 90 seconds the corneal flap was repositioned. The eye was irradiated at 30 mW/cm2 for 90 seconds with continuous UVA.
Other: Control group; LASIK only	Procedure: LASIK; Femtosecond-assisted preparation of a corneal flap and subsequently excimer-laser ablation of corneal stroma. Repositioning of the corneal flap and installation of a therapeutic contact lens.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
uncorrected distant visual acuity	uncorrected distant visual acuity (logarithmic minimum angle of resolution)	12 months postoperative
best spectacle corrected distant visual acuity	best spectacle corrected distant visual acuity (logarithmic minimum angle of resolution)	12 months postoperative
spherical equivalent	spherical equivalent (diopter)	12 months postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
endothelial cell count	endothelial cell count (number of cells/ mm2)	12 months postoperative
Corneal thickness	Corneal thickness (micro millimeter)	12 months postoperative
Subjective visual quality	Questionnaire regarding subjective optical quality (scale from 0 - 100; 0 = minimal, 100 = maximum)	12 months postoperative

Collaborators and Investigators

• Sponsor: University Clinic Frankfurt
• Collaborators: Glaukos Corporation
• Investigators: Principal Investigator: Thomas Kohnen, Prof. Dr., Augenklinik des Universitätsklinikum der Goethe Unveristät Frankfurt am Main

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2014
• Primary Completion (Actual): July 3, 2018
• Study Completion (Actual): July 3, 2018

Study Registration Dates

• First Submitted: April 3, 2019
• First Submitted That Met QC Criteria: April 10, 2019
• First Posted (Actual): April 12, 2019

Study Record Updates

• Last Update Posted (Actual): April 12, 2019
• Last Update Submitted That Met QC Criteria: April 10, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism; Myopia
• Other Study ID Numbers: 154/14

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No