Collagen Crosslinking for Keratoconus - a Randomized Controlled Clinical Trial (CXL-RCT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by Sahlgrenska University Hospital, Sweden
Sponsor:
Collaborator:
Göteborg University
Information provided by (Responsible Party):
Wolf K Wonneberger, MD, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT01604135
First received: May 21, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
  Purpose

The purpose of this study is to determine whether corneal collagen crosslinking is effective in the treatment of progressive keratoconus.


Condition Intervention Phase
Keratoconus
Pellucid Marginal Degeneration
Device: Corneal Collagen Crosslinking
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Collagen Crosslinking for Keratoconus - a Randomized Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • Kmax [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Kmax is defined as the steepest radius of curvature of the anterior corneal surface as measured by Scheimpflug-topography (Pentacam, Oculus Inc.). An increase of less than 1 diopter (D) from baseline at 12 months is defined as non-progression.


Secondary Outcome Measures:
  • Sim-K-astigmatism [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Sim-K-astigmatism (Sim-K-ast) is defined as the absolute amount of anterior corneal astigmatism related to the Sim-Ks as measured by Scheimpflug-topography (Pentacam, Oculus Inc.). An increase of less than 1 D from baseline at 12 months is defined as non progression.

  • MRSE [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Manifest Refractive Spherical Equivalent. The spherical equivalent is calculated by algebraic addition of the spherical power and half the cylindrical power of an eye. An eye with a specific spherical equivalent power has the closest overall effect to a given toric lens. A decrease of less than 0.5 D from baseline at 12 months is defined as non-progression.

  • UCDVA [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    UCDVA is defined as the uncorrected distance visual acuity measured with an Early Treatment of Diabetic Retinopathy Study (ETDRS)-chart and expressed in numbers of letters. A decrease of less than 5 letters (one line) from baseline at 12 months is defined as stable BCDVA.

  • BSCDVA [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    BSCDVA is defined as the the best spectacle corrected distance visual acuity measured with an ETDRS-chart and expressed in numbers of letters. A decrease of less than 5 letters (one line) from baseline at 12 months is defined as stable BCDVA.


Estimated Enrollment: 200
Study Start Date: May 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Corneal Collagen Crosslinking
The keratokonic eye which progresses most is included and randomized. Significant progression is defined in the eligibility criteria section. When assessing progression, weighting of the relevant parameters will be as follows: Kmax>Sim-K-ast>S.E. If, for example, the right eye decreased more in S.E. than the left but the left increased more in Kmax, the left eye will be included. If randomized to the treatment arm the cornea is treated with collagen crosslinking as described below.
Device: Corneal Collagen Crosslinking
Keratoconic corneas that show significant progression as specified in the inclusion criteria section will receive one single treatment with CXL if randomized to the treatment arm. A treatment protocol based on 30 minutes dropping with riboflavin/dextran solution and 10 minutes UV-illumination treatment will be used.
Other Names:
  • Cross-Linking Procedure UV-X 2000
  • UV-X 2000 Illumination system
  • Innocross-R 0.1% dextran 20% solution
  • Innocross-R hypotonic riboflavin 0.1%
No Intervention: Control group
The keratokonic eye which progresses most is included and randomized to either the treatment group (CXL) or the control group.

Detailed Description:

Keratoconus is a noninflammatory, asymmetrical, progressive corneal ectasia caused by biomechanical instability of the corneal stroma. Treatment modalities are primarily glasses or contact lenses. It has been estimated that one out of five patients will progress to such an extent that a corneal transplant is necessary to regain useful vision.

Corneal collagen crosslinking (CXL) is a relatively new treatment modality intended to halt progression of keratoconus. This study investigates the efficacy av CXL in stabilizing the cornea in keratoconus by means of a randomized controlled clinical trial.

Participants are eligible for inclusion if progressive keratoconus is confirmed and the inclusion criteria are met. Follow-up after inclusion is at 1 week (treatment group), 1, 3, 6 and 12 months. Pre- and post-inclusion examinations include measurement of uncorrected distance visual acuity (UCDVA), best spectacle corrected distance visual acuity (BSCDVA), Scheimpflug-topography and slitlamp examination.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Keratoconus or pellucid marginal degeneration diagnosis determined clinically and topographically (KISA%-index)
  • Change (increase) of Kmax by at least 1D from baseline at 6 months and/or
  • Change (increase) of Sim-K-ast by at least 1D from baseline at 6 months and/or
  • Change (decrease) of MRSE by at least 0.5D from baseline at 6 months
  • Ability to stop contact lens (rigid and soft) wear at least two weeks prior to next exam
  • Signed written informed consent

Exclusion Criteria:

  • Age < 18 years
  • Pregnancy
  • Breast feeding
  • History of corneal surgery
  • History of ocular herpes simplex infection
  • Minimal corneal thickness < 300 micrometers
  • Recurrent corneal erosions
  • Other corneal (e g endothelial) or conjunktival diseases
  • Neurodermatitis
  • Severe forms av atopic disease
  • Collagenoses, autoimmune or other systemic disease
  • Systemic treatment with high doses of steroids
  • Severe scarring och striae of the cornea

Relative exclusion criteria:

  • Kmax > 58D
  • Minimal corneal thickness < 400 micrometers (a modified CXL-treatment will be used swelling the cornea before UV-illumination treatment).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01604135

Contacts
Contact: Wolf K Wonneberger, MD 00463431000 wonneberger@yahoo.com
Contact: Madeleine Zetterberg, MD, PhD 00463431000 madeleine.zetterberg@anatcell.gu.se

Locations
Sweden
Department of Ophthalmology, Sahlgrenska University Hospital Recruiting
Mölndal, Västra Götalandsregionen, Sweden, 43180
Principal Investigator: Wolf K Wonneberger, MD         
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Göteborg University
Investigators
Study Chair: Madeleine Zetterberg, MD, PhD Sahlgrenska University Hospital, Sweden
Study Director: Margareta Claesson, MD, PhD Sahlgrenska University Hospital, Sweden
  More Information

Publications:
Responsible Party: Wolf K Wonneberger, MD, Ophthalmologist, Cornea and External Diseases Team, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT01604135     History of Changes
Other Study ID Numbers: DNR-949-11
Study First Received: May 21, 2012
Last Updated: May 21, 2012
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Sahlgrenska University Hospital, Sweden:
Collagen crosslinking
Keratoconus
Pellucid marginal degeneration

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on October 19, 2014