Corneal cross-linking versus standard care in children with keratoconus, a randomised, multicentre, observer-masked trial of efficacy and safety
Comprehensive Clinical Trials Unit at UCL
Duration of Study in the UK
2 years, 1 months, 31 days
Keratoconus is a long-term eye disorder characterised by the thinning and bulging of the normally round cornea into a cone-like shape that causes progressive distortion of vision. In advanced cases, corneal replacement by a transplant is needed. Corneal collagen cross-linking (CXL) is a procedure that involves the removal of the surface layer of the cornea (epithelium-off CXL), the administration of riboflavin (vitamin B2) eye drops and exposure of the cornea to UV light. CXL is a new treatment that is believed to stop keratoconus from getting worse, by increasing stiffness of the cornea and arresting progression. Keratoconus usually affects both eyes (although often asymmetrically) and in most cases starts in teens. It is often more advanced if diagnosed in childhood, and subsequently progresses faster.
The aim is to study the efficacy and safety of epithelium-off CXL in children with keratoconus, and to compare it to standard care with provision of glasses and/or contact lenses as required for best vision. Sixty eligible children aged 10-16 years with mild to moderate keratoconus will be randomised to participate in the study. The trial will be conducted in three secondary care NHS clinics in England: Moorfields Eye Hospital NHS Foundation Trust, the Royal Liverpool & Broadgreen University Hospitals NHS Trusts and Sheffield Teaching Hospital NHS Foundation Trust. In the intervention arm, the corneal epithelium will be removed, riboflavin eye drops administered, and one or both eyes exposed to UV light. Participants will be followed up at 3-monthly visits for 18 months, and those with unconfirmed progression at the 18 month visit will have an additional 21 month visit to confirm progression. The primary outcome measures of the study are whether cross-linking is efficacious and safe in patients under 17 years.
London - Brent Research Ethics Committee
Date of REC Opinion
30 Jun 2016
Further Information Favourable Opinion