Abstract
Introduction: Corneal crosslinking (CXL) is the only treatment capable of halting the progression of keratoconus , a progressive corneal thinning disease that causes distorted vision. Despite its widespread clinical adoption and a rapidly expanding commercial market , the evidence supporting its efficacy and safety remains contradictory and is often of low quality.
Methods: This presentation reports the preliminary findings from a large-scale systematic review and meta-analysis designed to investigate the sources of this clinical heterogeneity. We analysed 311 studies published between 2015 and 2025, which included a total of 30,086 eyes. Data was extracted across 19 domains, including study design, patient demographics, intervention details, and all reported safety and efficacy endpoints .
Results: The analysis revealed profound heterogeneity across the entire body of evidence. We identified over 100 different combinations of CXL treatment modalities and 536 unique outcome measures , with 119 different measures for topography alone. Standardisation of study methodology was severely lacking: 29% of studies failed to report a disease verification strategy, and thresholds for defining progression varied widely. Furthermore, safety reporting was deficient, with 35% of studies providing no safety data. In studies that did report safety, the overall likelihood of an adverse event was approximately 30%.
Conclusion: A significant gap exists between the rapid commercialisation of CXL devices and the generation of high-quality clinical evidence. The extreme lack of standardisation in treatment protocols, outcome measures, and study design makes it nearly impossible to compare interventions or establish clear efficacy reliably. This review highlights the urgent need for a new translational framework, moving from a focus on devices to a consensus on data standards, to validate the true impact of CXL technology and ensure patient safety
Methods: This presentation reports the preliminary findings from a large-scale systematic review and meta-analysis designed to investigate the sources of this clinical heterogeneity. We analysed 311 studies published between 2015 and 2025, which included a total of 30,086 eyes. Data was extracted across 19 domains, including study design, patient demographics, intervention details, and all reported safety and efficacy endpoints .
Results: The analysis revealed profound heterogeneity across the entire body of evidence. We identified over 100 different combinations of CXL treatment modalities and 536 unique outcome measures , with 119 different measures for topography alone. Standardisation of study methodology was severely lacking: 29% of studies failed to report a disease verification strategy, and thresholds for defining progression varied widely. Furthermore, safety reporting was deficient, with 35% of studies providing no safety data. In studies that did report safety, the overall likelihood of an adverse event was approximately 30%.
Conclusion: A significant gap exists between the rapid commercialisation of CXL devices and the generation of high-quality clinical evidence. The extreme lack of standardisation in treatment protocols, outcome measures, and study design makes it nearly impossible to compare interventions or establish clear efficacy reliably. This review highlights the urgent need for a new translational framework, moving from a focus on devices to a consensus on data standards, to validate the true impact of CXL technology and ensure patient safety
| Original language | English |
|---|---|
| Publication status | Published - 21 Oct 2025 |
| Event | 7th International Conference on Medicine in Novel Technology and Devices: Medicine in Novel Technology and Devices - Hangzhou International Campus, Hangzhou, China Duration: 21 Oct 2025 → 24 Oct 2025 Conference number: 7 |
Conference
| Conference | 7th International Conference on Medicine in Novel Technology and Devices |
|---|---|
| Abbreviated title | NMTD |
| Country/Territory | China |
| City | Hangzhou |
| Period | 21/10/25 → 24/10/25 |
Keywords
- Corneal Crosslinking
- Keratoconus
- Systematic Review
- Meta-Analysis
- Heterogeneity
- Outcome Measures
- Data Standards
- Clinical Efficacy
- Patient Safety
- Translational Framework
