None listed
Conditions
Brief summary
This is a study to determine the safety and effectiveness of corneal collagen crosslinking in young persons aged 10-15 years and 11 months who have been diagnosed with progressive keratoconus. Keratoconus is a condition that causes distortion of the cornea (the clear, front window of the eye) that results in reduced vision. In the early stages, vision can be corrected with glasses or contact lenses, but in the more advanced stages a cornean transplant may be required. Collagen cross-linking is a treatment involving the use of riboflavin (vitamin B2) and ultraviolet light that has been shown to slow the progression of keratoconus in adults with a low risk of complications. We would like to study the safety and effectiveness of crosslinking in children.
Interventions
This is a non-comparator trial to test the safety and efficacy of corneal collagen crosslinking in cases of progressive keratoconus in the paediatric age group. Corneal collagen-crosslinking involves the use of riboflavin (vitamin B2) and UVA (ultraviolet A) light. Riboflavin 0.1% will be applied to the cornea every 1-3 minutes for 30 minutes, then for a further 30 minutes during UVA treatment. Corneal pachymetry will be performed every 10 minutes, and if the pachymetry is below 400um, isotonic
This is a non-comparator trial to test the safety and efficacy of corneal collagen crosslinking in cases of progressive keratoconus in the paediatric age group. Corneal collagen-crosslinking involves the use of riboflavin (vitamin B2) and UVA (ultraviolet A) light. Riboflavin 0.1% will be applied to the cornea every 1-3 minutes for 30 minutes, then for a further 30 minutes during UVA treatment. Corneal pachymetry will be performed every 10 minutes, and if the pachymetry is below 400um, isotonic riboflavin (10mg/2mL) will replace 0.1% riboflavin. The UV-X device (IROC, Switzerland) will be used to deliver UVA at 3mW/cm2 for 30 minutes. This is a single treatment, and participants will be followed up at intervals over a period of 10 years to assess for safety and efficacy.
Sponsors
Royal Victorian Eye and Ear Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
10 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
1. Sex: Males or females 2. Age: 10 years to 15 years and 11 months 3. Progression documented by an increase of > 1.00D in the steepest keratometry value (or simK) measured by manual keratometry, automated keratometry or computerised videokeratography or where there is unambiguous documented evidence of progression (in the absence of keratometry) with the agreement of two or more corneal consultants
Exclusion criteria
1. Keratometry values greater than 60D and contact lens intolerant 2. Corneal pachymetry <400um (thinnest point measured by Orbscan videokeratography or Pentacam and confirmed by ultrasonic pachymetry) 3. History of previous corneal surgery 4. Presence of visually significant corneal scarring 5. Existance of other corneal pathology 6. A history of herpetic keratitis, chemical injury, delayed epithelial healing or recurrent erosion syndrome 7. Pregnancy or breast-feeding at the time of initial treatment 8. Allergy to riboflavin or dextran 9. Unable to comply with follow-up
Outcome results
None listed