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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03913338
Recruitment Status : Completed
First Posted : April 12, 2019
Last Update Posted : April 12, 2019
Sponsor:
Collaborator:
Avedro, Inc.
Information provided by (Responsible Party):
Professor Dr. med. Thomas Kohnen, 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.

Condition or disease Intervention/treatment Phase
Myopia Myopic Astigmatism Crosslinking Corneal Ectasia Myopic Regression Procedure: LasikXtra Procedure: LASIK Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, intra-patient controlled, clinical trial
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 24, 2014
Actual Primary Completion Date : July 3, 2018
Actual Study Completion Date : July 3, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913338


Locations
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Germany
Department of ophthalmology University clinic Frankfurt
Frankfurt am Main, Hessen, Germany, 60590
Sponsors and Collaborators
University Clinic Frankfurt
Avedro, Inc.
Investigators
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Principal Investigator: Thomas Kohnen, Prof. Dr. Augenklinik des Universitätsklinikum der Goethe Unveristät Frankfurt am Main

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Responsible Party: Professor Dr. med. Thomas Kohnen, Head of Ophthalmology, Principal Investigator, Clinical Professor, University Clinic Frankfurt
ClinicalTrials.gov Identifier: NCT03913338     History of Changes
Other Study ID Numbers: 154/14
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myopia
Astigmatism
Refractive Errors
Eye Diseases
Riboflavin
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents