A Randomised, Controlled, Observer-Masked Trial of Corneal Cross-Linking for Progressive Keratoconus in Children: The KERALINK Protocol

AI Generated Summary*

KERALINK is a protocol for an observer-masked randomised trial across five UK centres testing whether epithelium-off corneal cross-linking slows keratoconus progression versus standard care (glasses or contact lenses) in children aged 10 to 16 years. Sixty participants, exceeding the 46 needed for 90% power to detect a 1.5 D difference, will be allocated 1:1 and reviewed every 3 months for 18 months; eligibility requires a rise of at least 1.5 D in Kmax or K2 between two examinations at least 3 months apart. The primary endpoint is baseline-adjusted K2 at 18 months, recorded by masked optometrists. Secondary endpoints include progression, acuity, refraction, apical thickness, quality of life and adverse events. Randomisation began October 2016; no results are reported.

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