Related Experiment Video
Updated: Jan 19, 2026
Three Different Protocols of Corneal Collagen Crosslinking in Keratoconus: Conventional, Accelerated and Iontophoresis
Published on: November 12, 2015
A randomised, controlled, observer-masked trial of corneal cross-linking for progressive keratoconus in children: the
Kashfia Chowdhury1, Caroline Dore1, Jennifer M Burr2
1Comprehensive Clinical Trials Unit, University College London, London, UK.
Insights
The KERALINK trial investigates if corneal cross-linking (CXL) halts keratoconus progression in young patients. This study compares CXL to standard care, assessing visual acuity and corneal changes over 18 months.
Area of Science:
- Ophthalmology
- Corneal Diseases
- Regenerative Medicine
Background:
- Keratoconus is a progressive eye condition affecting young individuals.
- Standard care for keratoconus aims to correct vision but does not halt progression.
- Corneal cross-linking (CXL) is a potential treatment to strengthen the cornea and stop disease advancement.
Purpose of the Study:
- To evaluate the efficacy of epithelium-off corneal cross-linking (CXL) in reducing keratoconus progression in patients under 17 years old.
- To compare CXL treatment with standard care in managing progressive keratoconus.
- To assess the impact of CXL on visual acuity, refraction, and corneal topography.
Main Methods:
- A randomized controlled, observer-masked, multicentre trial involving 60 participants (30 per group) aged 10-16 years with progressive keratoconus.
- Participants were randomized to receive either epithelium-off CXL or standard care (spectacles/contact lenses).
- Follow-up occurred 3-monthly for 18 months, with K2 on corneal topography as the primary outcome measure for progression.
Main Results:
- The primary outcome is the between-group difference in K2 at 18 months, adjusted for baseline K2.
- Secondary outcomes include keratoconus progression rates, time to progression, visual acuity, refraction, corneal thickness, and adverse events.
- Patient-reported outcomes will also be collected via questionnaires.
Conclusions:
- The KERALINK trial will provide crucial data on the effectiveness of CXL in halting keratoconus progression in pediatric and adolescent populations.
- Findings will inform clinical practice regarding the management of progressive keratoconus in young patients.
- This study aims to establish CXL as a viable treatment to preserve vision and prevent advanced disease stages.
Introduction:
The KERALINK trial tests the hypothesis that corneal cross-linking (CXL) treatment reduces the progression of keratoconus in comparison to standard care in patients under 17 years old. 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.
Methods And Analysis:
A total of 30 participants will be randomised per group. Eligible participants aged 10-16 years with progressive keratoconus in one or both eyes will be recruited. Following randomisation, participants will be followed up 3-monthly for 18 months. The effect on progression will be determined by K2 on corneal topography. The primary outcome measure is between-group difference in K2 at 18 months adjusted for K2 at baseline examination. Secondary outcomes are the effect of CXL on (1) keratoconus progression, (2) time to keratoconus progression, (3) visual acuity, (4) refraction, (5) apical corneal thickness and (6) adverse events. Patient-reported effects will be explored by questionnaires.
Ethics And Dissemination:
Research Ethics Committee Approval was obtained on 30 June 2016 (ref: 14/LO/1937). Current protocol: V.5.0 (08/11/2017). Study findings will be published in peer-reviewed journals.
Trial Registration Number:
European Union clinial trials register (EudraCT) 2016-001460-11.
Related Concept Videos
07:29Three Different Protocols of Corneal Collagen Crosslinking in Keratoconus: Conventional, Accelerated and Iontophoresis
03:26Targeted Muscle Reinnervation: Surgical Protocol for a Randomized Controlled Trial in Postamputation Pain
05:04An Electrophysiology Protocol to Measure Reward Anticipation and Processing in Children
11:29Measuring the Functional Abilities of Children Aged 3-6 Years Old with Observational Methods and Computer Tools
10:21Protocol for HER2 FISH Using a Non-cross-linking, Formalin-free Tissue Fixative to Combine Advantages of Cryo-preservation and Formalin Fixation
14:05Behavioral Assessment of Hearing in 2 to 4 Year-old Children: A Two-interval, Observer-based Procedure Using Conditioned Play-based Responses