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Будущее интервенционного лечения кератоконуса: перспективы интеграции обогащенного кислородом кросс-линкинга с сохранением эпителия в комплексные схемы оказания медицинской помощи

The Future of Interventional Keratoconus Management: Perspectives on Integrating Epithelium-on Oxygen-Enriched Cross-Linking into Comprehensive Care Pathways.

Keratoconus causes debilitating vision loss and decreased quality of life in the United States and around the world. The disease is characterized by ectasia with progressive thinning and steepening of the cornea into the namesake conical shape with resulting vision loss due initially to irregular astigmatism and/or scarring, and later to corneal hydrops, with more severe scarring in more advanced cases.1 The condition is typically bilateral and asymmetric and results in irreversible vision loss and decreased quality of life.2 Historically, the management of keratoconus has consisted of optical correction of astigmatism in early stages and corneal transplantation in later stages. While optical correction in early stages can significantly improve visual acuity, it does not address the ongoing morphological changes associated with progression of the disease. More recently, the development of corneal cross-linking has shifted the treatment paradigm: cross-linking is a minimally invasive procedure that can stabilize corneal shape, prevent further ectasia and vision loss, and in some cases, regain lost vision.3,4 From 2016 to 2025, the only FDA-approved procedure involved removing the central 7–9mm of corneal epithelium to enhance riboflavin absorption (epithelium-off corneal cross-linking; Photrexa®, Glaukos Corporation, Aliso Viejo, CA). However, on October 20, 2025, the FDA approved epithelium-on cross-linking (Epioxa®, Glaukos Corporation). Epithelium-on oxygen-enriched corneal cross-linking is an incision-free drug therapy, catalyzed by oxygen and light, which leaves the epithelium intact and is able to halt keratoconus progression with one treatment. The preservation of the corneal epithelium improves the safety profile versus epithelium-off cross-linking, potentially producing a better benefit-to-risk ratio that may enable earlier intervention. In addition, unlike epithelium-off cross-linking, the FDA indication for epithelium-on cross-linking does not require a patient to have disease progression prior to treatment,5 further facilitating earlier intervention. As a newer technique, there are relatively fewer studies supporting epithelium-on treatment, although data are rapidly emerging. For example, recently the pivotal trial evaluating epithelium-on crosslinking reported meeting its primary efficacy endpoint (significant improvement in maximal keratometry versus sham/placebo) with no serious ocular safety issues.6 This study evaluated outcomes at 12 months post-treatment, while longer-term data will be valuable to inform any discussions regarding longer-term outcomes of epithelium-on versus -off crosslinking. There is certainly a solid evidence base supporting the need for early detection and treatment of keratoconus to prevent avoidable vision loss and preserve quality of life. In the present paper, we propose a strategy for implementing early diagnosis and treatment within the existing comprehensive eye care environment. This is a narrative literature review providing a novel perspective on recent developments in keratoconus diagnosis and management, with a focus on cross-linking technologies and evolving care models. Supporting data are drawn from the existing keratoconus literature with emphasis on new developments in diagnosis, treatment, and the broad public health impact of keratoconus. No specific hypotheses are proposed or tested via statistical analysis of data, and the conclusions are derived from interpretation of existing studies and expert opinion.

Early Detection Technologies and Their Integration with Epithelium-on Oxygen-Enriched Cross-Linking

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