ArticleOphthalmology and therapy2026
Randomized, Controlled Study to Evaluate the Safety and Efficacy of Oxygen-Enriched Epithelium-On Corneal Cross-Linking for the Treatment of Keratoconus.
Article in Ophthalmology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05759559 ([Trial of device that is not approved or cleared by the U.S. FDA]), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
[Trial of device that is not approved or cleared by the U.S. FDA]
Who cites it
1 citing paper in PubMed.
- The Future of Interventional Keratoconus Management: Perspectives on Integrating Epithelium-on Oxygen-Enriched Cross-Linking into Comprehensive Care Pathways.Therapeutics and clinical risk management · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThis phase 3, multicenter, sham procedure/placebo-controlled, double-masked, randomized clinical trial evaluated the safety and efficacy of oxygen-enriched epithelium-on corneal collagen cross-linking (CXL) for the treatment of keratoconus.
methodsThe trial enrolled patients aged 13 to 51 years diagnosed with keratoconus. Eyes were randomized in a 2:1 ratio to CXL treatment or sham/placebo. The CXL treatment group (200 eyes) received cross-linking using riboflavin 5'-phosphate ophthalmic solutions 0.239% and 0.177% with ultraviolet A (UV-A) irradiation and supplemental oxygen while the sham/placebo group (112 eyes) received placebo solutions and a sham irradiation procedure. The primary efficacy endpoint was the between-group difference in least squares (LS) mean change from baseline in maximum corneal curvature (K
resultsAt month 12, the LS mean K
conclusionEpithelium-on CXL using riboflavin ophthalmic solutions (riboflavin 5'-phosphate ophthalmic solutions 0.239% and 0.177%) with UV-A irradiation and supplemental oxygen is safe and effective for the treatment of keratoconus in pediatric patients and adults.
trial registrationClinicalTrials.gov identifier NCT05759559.
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Registered trials
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