Corneal cross-linking versus standard care in children with keratoconus - a randomised, multicentre, observer-masked trial of efficacy and safety (KERALINK): a statistical analysis plan.

Trials
Kashfia ChowdhuryDaniel F P Larkin

Abstract

The KERALINK trial tests the hypothesis that corneal cross-linking (CXL) treatment reduces the progression of keratoconus in comparison to standard care in patients aged 10-16 years. This article describes the statistical analysis plan for this trial as an update to the published protocol. It is written before the end of the patient follow-up, while the outcome of the trial is still unknown. KERALINK is a randomised controlled, observer-masked, multicentre trial in progressive keratoconus comparing epithelium-off CXL with standard care, including spectacles or contact lenses as necessary for best-corrected acuity. Keratoconus is a disorder of the shape of the cornea in which the normally round dome-shaped clear front window of the eye (cornea) thins progressively leading to a cone-like bulge. This impairs the ability of the eye to focus properly, causing reduced vision which requires spectacle or contact lens wear or, in a minority of patients, eventually corneal replacement by a transplant for best vision. The primary outcome measure is the between-group difference in K2 at 18 months adjusted for K2 at baseline examination. K2 is the value of the steepest corneal meridian as measured on Pentacam topography. Secondary outcomes ...Continue Reading

References

Dec 25, 2002·Journal of Cataract and Refractive Surgery·Stephen B Kaye, William F Harris
Aug 21, 2009·Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation·Katherine Stevens
Mar 25, 2010·BMJ : British Medical Journal·Kenneth F SchulzUNKNOWN CONSORT Group
May 29, 2010·The British Journal of Ophthalmology·Jyoti KhadkaJ Margaret Woodhouse
Aug 13, 2011·Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation·Julie RatcliffeMichael Sawyer
Jul 4, 2012·Clinical Trials : Journal of the Society for Clinical Trials·Ian R WhiteNicholas J Horton
Jul 14, 2012·PharmacoEconomics·Katherine Stevens

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Software Mentioned

CONSORT
KERALINK
Sealed Envelope
EQUATOR
Stata

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