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Treatment of Keratoconus With Advanced Corneal Crosslinking

Primary Purpose

Keratoconus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Corneal reshaping/crosslinking (CRXL)
Corneal Crosslinking (CXL)
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring Keratoconus, Corneal crosslinking, Corneal biomechanics, Corneal densitometry, Scheimpflug photography

Eligibility Criteria

18 Years - 28 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients planned for corneal crosslinking.
  • Progressive keratoconus documented with Scheimpflug photography using the Pentacam Scheimflug camera and/or repeated subjective refraction and keratometry.
  • A keratoconus diagnosis based on the Amsler-Krumeich grading and the "Total Deviation" KC quantification value from the "Belin-Ambrosio enhanced ectasia" measurements of the Pentacam Scheimpflug camera, and an altered red reflex and/or an irregular cornea seen as distortion of the keratometric mires.
  • Minimum corneal thickness of 400 µm at the thinnest point after epithelial removal.
  • 18-28 years of age
  • No ocular abnormalities except keratoconus
  • No previous ocular surgery
  • No cognitive insufficiency interfering with the informed consent.

Exclusion Criteria:

  • Age under 18 or over 28
  • Any corneal abnormalities except keratoconus
  • Previous ocular surgery
  • Cognitive insufficiency.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    No Intervention

    No Intervention

    Arm Label

    Corneal reshaping/crosslinking (CRXL)

    Corneal crosslinking (CXL)

    Control group to CRXL

    Control group to CXL

    Arm Description

    Corneal crosslinking with compression of the cornea using a sutured rigid contact lens during the treatment.

    Standard corneal crosslinking using the Dresden protocol.

    Healthy subjects, age- and sex-matched to the CRXL group.

    Healthy subjects, age- and sex-matched to the CXL group.

    Outcomes

    Primary Outcome Measures

    Change from baseline in refraction
    Refractive errors, including lower and higher order aberrations in the cornea

    Secondary Outcome Measures

    Change from baseline in ETDRS LogMAR visual acuity
    Uncorrected and best spectacle corrected visual acuity measured with the Early treatment diabetic retinopathy study, graded in logarithmic values of the minimal angle of resolution
    Change from baseline in corneal biomechanical stability measured with ORA
    Biomechanical stability assessed with the ocular response analyzer
    Change from baseline in corneal biomechanical stability measured with ART
    Biomechanical stability assessed with the applanation resonance tonometer
    Change from baseline in corneal biomechanical stability measured with GAT
    Biomechanical stability assessed with the Goldmann applanation tonometer
    Change from baseline in corneal densitometry
    Corneal light reflectivity (back scatter) assessed with the Pentacam HR Scheimpflug camera

    Full Information

    First Posted
    April 13, 2015
    Last Updated
    December 9, 2020
    Sponsor
    Umeå University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02425150
    Brief Title
    Treatment of Keratoconus With Advanced Corneal Crosslinking
    Official Title
    Treatment of Keratoconus With Advanced Corneal Crosslinking
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2009 (undefined)
    Primary Completion Date
    October 2014 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Umeå University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study was to determine whether mechanical compression of the cornea during corneal crosslinking for keratoconus using a sutured rigid contact lens can improve the optical outcomes of the treatment.
    Detailed Description
    The study is designed as a prospective, open, randomized controlled trial involving patients aged 18-28 years of both genders with uni- or bilateral keratoconus planned for routine corneal crosslinking at the Department of Ophthalmology, Umeå University Hospital, Umeå, Sweden. The study involves 30+30 eyes with keratoconus, which are randomized to receive either conventional corneal crosslinking (n=30) using the Dresden protocol or a modified treatment - corneal reshaping and crosslinking (n=30), where a rigid contact lens is sutured to the cornea during the treatment to flatten the corneal curvature and potentially improve the optical outcome after the treatment. Patients are randomized utilizing a list of unique random numbers between 1 and 60. All patients are informed about the procedures before consenting to participate in the study. The study also involves 60 eyes of healthy age- and sex-matched control subjects. At baseline, before treatment, each eye is evaluated with autorefractometer measurement, best spectacle-corrected LogMAR visual acuity, Pentacam Scheimpflug photography, Goldmann applanation tonometry and biomicroscopy. The corneal biomechanical characteristics are assessed with applanation resonance tonometry and the ocular response analyzer. The investigations are repeated at 1 month, 6 months, 2 years and 5 years after the treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Keratoconus
    Keywords
    Keratoconus, Corneal crosslinking, Corneal biomechanics, Corneal densitometry, Scheimpflug photography

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Corneal reshaping/crosslinking (CRXL)
    Arm Type
    Experimental
    Arm Description
    Corneal crosslinking with compression of the cornea using a sutured rigid contact lens during the treatment.
    Arm Title
    Corneal crosslinking (CXL)
    Arm Type
    Active Comparator
    Arm Description
    Standard corneal crosslinking using the Dresden protocol.
    Arm Title
    Control group to CRXL
    Arm Type
    No Intervention
    Arm Description
    Healthy subjects, age- and sex-matched to the CRXL group.
    Arm Title
    Control group to CXL
    Arm Type
    No Intervention
    Arm Description
    Healthy subjects, age- and sex-matched to the CXL group.
    Intervention Type
    Procedure
    Intervention Name(s)
    Corneal reshaping/crosslinking (CRXL)
    Intervention Description
    The keratoconus cornea is treated with epithelial debridement in local anesthesia, is soaked in Riboflavin by repeated topical application during 30 minutes. A flat, rigid contact lens is sutured to the cornea and the cornea and is then irradiated with ultraviolet light 5.4 J/cm2 during 30 minutes.
    Intervention Type
    Procedure
    Intervention Name(s)
    Corneal Crosslinking (CXL)
    Intervention Description
    The keratoconus cornea is treated with epithelial debridement in local anesthesia, is soaked in Riboflavin by repeated topical application during 30 minutes. The cornea and is then irradiated with ultraviolet light 5.4 J/cm2 during 30 minutes.
    Primary Outcome Measure Information:
    Title
    Change from baseline in refraction
    Description
    Refractive errors, including lower and higher order aberrations in the cornea
    Time Frame
    1, 6, 24 and 60 months after the treatment
    Secondary Outcome Measure Information:
    Title
    Change from baseline in ETDRS LogMAR visual acuity
    Description
    Uncorrected and best spectacle corrected visual acuity measured with the Early treatment diabetic retinopathy study, graded in logarithmic values of the minimal angle of resolution
    Time Frame
    1, 6, 24 and 60 months after the treatment
    Title
    Change from baseline in corneal biomechanical stability measured with ORA
    Description
    Biomechanical stability assessed with the ocular response analyzer
    Time Frame
    1, 6, 24 and 60 months after the treatment
    Title
    Change from baseline in corneal biomechanical stability measured with ART
    Description
    Biomechanical stability assessed with the applanation resonance tonometer
    Time Frame
    1, 6, 24 and 60 months after the treatment
    Title
    Change from baseline in corneal biomechanical stability measured with GAT
    Description
    Biomechanical stability assessed with the Goldmann applanation tonometer
    Time Frame
    1, 6, 24 and 60 months after the treatment
    Title
    Change from baseline in corneal densitometry
    Description
    Corneal light reflectivity (back scatter) assessed with the Pentacam HR Scheimpflug camera
    Time Frame
    1, 6, 24 and 60 months after the treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    28 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients planned for corneal crosslinking. Progressive keratoconus documented with Scheimpflug photography using the Pentacam Scheimflug camera and/or repeated subjective refraction and keratometry. A keratoconus diagnosis based on the Amsler-Krumeich grading and the "Total Deviation" KC quantification value from the "Belin-Ambrosio enhanced ectasia" measurements of the Pentacam Scheimpflug camera, and an altered red reflex and/or an irregular cornea seen as distortion of the keratometric mires. Minimum corneal thickness of 400 µm at the thinnest point after epithelial removal. 18-28 years of age No ocular abnormalities except keratoconus No previous ocular surgery No cognitive insufficiency interfering with the informed consent. Exclusion Criteria: Age under 18 or over 28 Any corneal abnormalities except keratoconus Previous ocular surgery Cognitive insufficiency.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anders Behndig, Professor
    Organizational Affiliation
    Umeå University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24628999
    Citation
    Beckman Rehnman J, Behndig A, Hallberg P, Linden C. Initial results from mechanical compression of the cornea during crosslinking for keratoconus. Acta Ophthalmol. 2014 Nov;92(7):644-9. doi: 10.1111/aos.12380. Epub 2014 Mar 15.
    Results Reference
    background
    PubMed Identifier
    25171564
    Citation
    Beckman Rehnman J, Behndig A, Hallberg P, Linden C. Increased corneal hysteresis after corneal collagen crosslinking: a study based on applanation resonance technology. JAMA Ophthalmol. 2014 Dec;132(12):1426-32. doi: 10.1001/jamaophthalmol.2014.3029.
    Results Reference
    background
    PubMed Identifier
    21873026
    Citation
    Beckman Rehnman J, Janbaz CC, Behndig A, Linden C. Spatial distribution of corneal light scattering after corneal collagen crosslinking. J Cataract Refract Surg. 2011 Nov;37(11):1939-44. doi: 10.1016/j.jcrs.2011.05.028. Epub 2011 Aug 27.
    Results Reference
    result
    PubMed Identifier
    26312777
    Citation
    Rehnman JB, Linden C, Hallberg P, Behndig A. Treatment Effect and Corneal Light Scattering With 2 Corneal Cross-linking Protocols: A Randomized Clinical Trial. JAMA Ophthalmol. 2015 Nov;133(11):1254-60. doi: 10.1001/jamaophthalmol.2015.2852.
    Results Reference
    derived

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    Treatment of Keratoconus With Advanced Corneal Crosslinking

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