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

Not Applicable

Completed

• Conditions: Myopic Astigmatism; Myopia; Corneal Ectasia; Crosslinking; Myopic Regression
• Interventions: Procedure: LasikXtra; Procedure: LASIK

• Registration Number: NCT03913338
• Lead Sponsor: University Clinic Frankfurt

Brief Summary

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.

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 Timeline

• Study Start: 2014-07-24
• Primary Completion: 2018-07-03
• Study Completion: 2018-07-03
• Status Verified: 2019-04
• Study First Submitted: 2019-04-03
• Study First Submitted QC: 2019-04-10
• Last Update Submitted: 2019-04-10
• Study First Posted: 2019-04-12
• Last Update Posted: 2019-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	LasikXtra	LASIK followed by intraoperative application of riboflavin under the flap and crosslinking after reposition of the flap.
Control group	LASIK	LASIK only

Primary Outcome Measures

Name	Time	Method
best spectacle corrected distant visual acuity	12 months postoperative	best spectacle corrected distant visual acuity (logarithmic minimum angle of resolution)
uncorrected distant visual acuity	12 months postoperative	uncorrected distant visual acuity (logarithmic minimum angle of resolution)
spherical equivalent	12 months postoperative	spherical equivalent (diopter)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of ophthalmology University clinic Frankfurt; 🇩🇪 Frankfurt am Main, Hessen, Germany