Collagen Crosslinking for Keratoconus - a Randomized Controlled Clinical Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 200
Summary
- Conditions
- Keratoconus
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 30 years
- Gender
- Both males and females
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 tran...
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.
Tracking Information
- NCT #
- NCT01604135
- Collaborators
- Göteborg University
- Investigators
- Study Chair: Madeleine Zetterberg, MD, PhD Sahlgrenska University Hospital, Sweden Study Director: Margareta Claesson, MD, PhD Sahlgrenska University Hospital, Sweden