None listed
Conditions
Brief summary
The technique of collagen cross-linking for keratoconus (a condition leading to thinning and protrusion of the cornea, the front clear window of the eye, leading to a reduction in vision) was introduced in Europe. It involves the use of riboflavin (vitamin B2) and ultraviolet light A, and has been shown in animal studies to strengthen the cornea. This trial was initiated to assess the effectiveness and safety of this treatment in comparison to a second group of participants who have the disease but are not given the cross-linking treatment. It runs over 5 years.
Interventions
corneal collagen cross-linking. Cross-linking is a single treatment involving the use of riboflavin and UVA light to increase the strength of the cornea. The cornea is treated with riboflavin drops for 30 minutes followed by exposure to UVA irradiation for a 30 minutes, during which the riboflavin drops are continued.
Sponsors
Royal Victorian Eye and Ear Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
At least one of the following criteria met over the preceding 12 months: an increase of at least 1 diopter in the steepest simulated keratometry reading derived from computerized videokeratography or in the steepest meridian measured by manual keratometry; an increase in astigmatism as determined by manifest subjective refraction of at least 1 diopter; or a 0.1mm or more decrease in back optic-zone radius of the best fitting contact lens
Exclusion criteria
Minimum corneal thickness less than 400 microns; axial corneal scarring, previous refractive or other corneal surgery; a history of chemical burns; severe infections or other corneal or ocular surface disorders; patients who were pregnant or breastfeeding at the time of enrolment
Outcome results
None listed