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

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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

Tracking Information
First Submitted Date  ICMJE April 3, 2019
First Posted Date  ICMJE April 12, 2019
Last Update Posted Date April 12, 2019
Actual Study Start Date  ICMJE July 24, 2014
Actual Primary Completion Date July 3, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2019)
  • uncorrected distant visual acuity [ Time Frame: 12 months postoperative ]
    uncorrected distant visual acuity (logarithmic minimum angle of resolution)
  • best spectacle corrected distant visual acuity [ Time Frame: 12 months postoperative ]
    best spectacle corrected distant visual acuity (logarithmic minimum angle of resolution)
  • spherical equivalent [ Time Frame: 12 months postoperative ]
    spherical equivalent (diopter)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2019)
  • endothelial cell count [ Time Frame: 12 months postoperative ]
    endothelial cell count (number of cells/ mm2)
  • Corneal thickness [ Time Frame: 12 months postoperative ]
    Corneal thickness (micro millimeter)
  • Subjective visual quality [ Time Frame: 12 months postoperative ]
    Questionnaire regarding subjective optical quality (scale from 0 - 100; 0 = minimal, 100 = maximum)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Laser In-situ Keratomileusis With Crosslinking Compared to Conventional LASIK in Patients With High Myopia
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Prospective, randomized, intra-patient controlled, clinical trial
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Myopia
  • Myopic Astigmatism
  • Crosslinking
  • Corneal Ectasia
  • Myopic Regression
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Study group
    LASIK followed by intraoperative application of riboflavin under the flap and crosslinking after reposition of the flap.
    Intervention: Procedure: LasikXtra
  • Control group
    LASIK only
    Intervention: Procedure: LASIK
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2019)
26
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 3, 2018
Actual Primary Completion Date July 3, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03913338
Other Study ID Numbers  ICMJE 154/14
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Professor Dr. med. Thomas Kohnen, University Clinic Frankfurt
Study Sponsor  ICMJE University Clinic Frankfurt
Collaborators  ICMJE Avedro, Inc.
Investigators  ICMJE
Principal Investigator: Thomas Kohnen, Prof. Dr. Augenklinik des Universitätsklinikum der Goethe Unveristät Frankfurt am Main
PRS Account University Clinic Frankfurt
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP