Collagen Crosslinking for Keratoconus - a Randomized Controlled Clinical Trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Keratoconus
- Sponsor
- Sahlgrenska University Hospital, Sweden
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Kmax
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Investigators
Wolf K Wonneberger, MD
Ophthalmologist, Cornea and External Diseases Team
Sahlgrenska University Hospital, Sweden
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
Outcomes
Primary Outcomes
Kmax
Time Frame: 12 months
Kmax is defined as the steepest radius of curvature of the anterior corneal surface. It is 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 Outcomes
- Sim-K-astigmatism(12 months)
- UCDVA(12 months)
- BSCDVA(12 months)
- MRSE(12 months)