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

NCT ID: NCT03913338

Last Updated: 2019-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-24
• Study Completion Date: 2018-07-03

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.

Conditions

Myopia; Myopic Astigmatism; Crosslinking; Corneal Ectasia; Myopic Regression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Study group

LASIK followed by intraoperative application of riboflavin under the flap and crosslinking after reposition of the flap.

Group Type: OTHER

LasikXtra

Intervention Type: PROCEDURE

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.

Control group

LASIK only

Group Type: OTHER

LASIK

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Glaukos Corporation

INDUSTRY

Sponsor Role: collaborator

University Clinic Frankfurt

OTHER

Sponsor Role: lead

Responsible Party

Professor Dr. med. Thomas Kohnen

Head of Ophthalmology, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Kohnen, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Augenklinik des Universitätsklinikum der Goethe Unveristät Frankfurt am Main

Locations

Department of ophthalmology University clinic Frankfurt

Frankfurt am Main, Hesse, Germany

Countries

Germany

Other Identifiers

154/14

Identifier Type: -

Identifier Source: org_study_id