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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03913338
• Other study ID #: 154/14
• Status: Completed
• Phase: N/A
• Start date: July 24, 2014
• Est. completion date: July 3, 2018

Study information

• Verified date: April 2019
• Source: University Clinic Frankfurt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 3, 2018
• Est. primary completion date: July 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Astigmatism
• Corneal Ectasia
• Crosslinking
• Myopia
• Myopic Astigmatism
• Myopic Regression

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Department of ophthalmology University clinic Frankfurt	Frankfurt am Main	Hessen

Sponsors (2)

Lead Sponsor	Collaborator
University Clinic Frankfurt	Avedro, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	uncorrected distant visual acuity	uncorrected distant visual acuity (logarithmic minimum angle of resolution)	12 months postoperative
Primary	best spectacle corrected distant visual acuity	best spectacle corrected distant visual acuity (logarithmic minimum angle of resolution)	12 months postoperative
Primary	spherical equivalent	spherical equivalent (diopter)	12 months postoperative
Secondary	endothelial cell count	endothelial cell count (number of cells/ mm2)	12 months postoperative
Secondary	Corneal thickness	Corneal thickness (micro millimeter)	12 months postoperative
Secondary	Subjective visual quality	Questionnaire regarding subjective optical quality (scale from 0 - 100; 0 = minimal, 100 = maximum)	12 months postoperative