Brief Title
Collagen Crosslinking for Keratoconus - a Randomized Controlled Clinical Trial
Official Title
Collagen Crosslinking for Keratoconus - a Randomized Controlled Clinical Trial
Brief Summary
The purpose of this study is to determine whether corneal collagen crosslinking is effective
in the treatment of progressive keratoconus.
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 treatment modality that intends 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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Kmax
Secondary Outcome
Sim-K-astigmatism
Condition
Keratoconus
Intervention
Corneal Collagen Crosslinking
Study Arms / Comparison Groups
Corneal Collagen Crosslinking
Description: The keratokonic eye which progresses most is included and randomized. Significant progression is defined in the eligibility criteria section. If randomized to the treatment arm the cornea is treated with collagen crosslinking as described below.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
36
Start Date
May 2012
Completion Date
April 2022
Primary Completion Date
April 2022
Eligibility Criteria
Inclusion Criteria:
- Keratoconus diagnosis determined clinically and topographically (KISA%- index)
- Significant progression is defined as 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. Kmax is defined as the steepest radius of curvature (either the
maximum simulated K-reading or the maximum K-reading in the 3-mm zone or the 5-mm
zone) of the anterior corneal surface that progressed the most during 6 months
observation
- 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).
Gender
All
Ages
18 Years - 30 Years
Accepts Healthy Volunteers
No
Contacts
Madeleine Zetterberg, MD, PhD, ,
Location Countries
Sweden
Location Countries
Sweden
Administrative Informations
NCT ID
NCT01604135
Organization ID
DNR-949-11
Responsible Party
Principal Investigator
Study Sponsor
Sahlgrenska University Hospital, Sweden
Collaborators
Göteborg University
Study Sponsor
Madeleine Zetterberg, MD, PhD, Study Chair, Sahlgrenska University Hospital, Sweden
Verification Date
April 2021