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Completed

NCT Number: NCT03913338

Laser In-situ Keratomileusis With Crosslinking Compared to Conventional LASIK 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.

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Key information

Conditions

Myopia Astigmatism Corneal Ectasia Crosslinking Eye Diseases Myopic Astigmatism Myopic Regression Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of ophthalmology University clinic Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LasikXtra

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.

LASIK

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.

Primary outcomes

  1. uncorrected distant visual acuity

    Time frame: 12 months postoperative

    uncorrected distant visual acuity (logarithmic minimum angle of resolution)

  2. best spectacle corrected distant visual acuity

    Time frame: 12 months postoperative

    best spectacle corrected distant visual acuity (logarithmic minimum angle of resolution)

  3. spherical equivalent

    Time frame: 12 months postoperative

    spherical equivalent (diopter)

Secondary outcomes

  1. endothelial cell count

    Time frame: 12 months postoperative

    endothelial cell count (number of cells/ mm2)

  2. Corneal thickness

    Time frame: 12 months postoperative

    Corneal thickness (micro millimeter)

  3. Subjective visual quality

    Time frame: 12 months postoperative

    Questionnaire regarding subjective optical quality (scale from 0 - 100; 0 = minimal, 100 = maximum)

Sponsors and collaborators

Lead sponsor

University Clinic Frankfurt

Other

Collaborators

  • Glaukos Corporation

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Apr 12, 2019
Registry last updated
Apr 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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