Cornea · 2026
A Multicenter, Randomized, Double-Masked, Sham-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Epithelium-on Corneal Crosslinking in Keratoconus Subjects 8 to 45 Years of Age: Baseline Endothelial Studies.
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Belin Michael Wellington, DeMarchi Janet, Benetz Beth Ann, Wu Qian, Sattar Abdus, Parsons Edward C, Szczotka-Flynn Loretta B, Lass Jonathan H
Аннотация
PURPOSE: Determine the correlation between central endothelial cell density (ECD) and keratoconus tomographic disease severity.
METHODS: A subcohort of 254 subjects (477 eyes) at 11 clinical sites enrolled in a phase III study of epithelium-on crosslinking in keratoconus (ages 15-45) underwent specular microscopy of the central endothelium OU at baseline before treatment. ECD was graded by 2 image analysts from a central image analysis reading center with adjudication if ECD differed by ≥5%. The correlation by linear regression between ECD with Pentacam Belin/Ambrósio display final "D," Anterior Radius of Curvature (ARC), Minimal Corneal Thickness (MinCT), and Posterior Elevation a Thinnest Point (PETP) PTI was examined.
RESULTS: Approximately 66.9% were male and 33.1% were female. Baseline ECD was 2802 ± 285 cells/mm2 (1868-3650 cells/mm2). In bivariate correlation analysis, ECD negatively correlated with age (r = -0.19, P < 0.01); final "D" (r = -0.25, P < 0.01); and PETP (r = -0.23, P < 0.01). ECD was positively correlated with ARC (r = 0.20, P < 0.01) and MinCT (r = 0.19, P < 0.01). ECD significantly decreased with age (β = -8.89, P < 0.01), with increasing final "D" (β = -8.68, P < 0.01), increasing PETP (β = -1.86, P < 0.01), decreasing ARC (β = 60.95, P < 0.01), and decreasing MinCT (β = 1.33, P < 0.01). Although ECD decreased with increasing disease severity and age, it remained relatively high, with only 1 eye showing an ECD <2000 cell/mm2.
CONCLUSIONS: Increasing keratoconus tomographic severity results in a significant decrease in ECD. However, even in the most advanced stages, the ECD remains within physiological range.
METHODS: A subcohort of 254 subjects (477 eyes) at 11 clinical sites enrolled in a phase III study of epithelium-on crosslinking in keratoconus (ages 15-45) underwent specular microscopy of the central endothelium OU at baseline before treatment. ECD was graded by 2 image analysts from a central image analysis reading center with adjudication if ECD differed by ≥5%. The correlation by linear regression between ECD with Pentacam Belin/Ambrósio display final "D," Anterior Radius of Curvature (ARC), Minimal Corneal Thickness (MinCT), and Posterior Elevation a Thinnest Point (PETP) PTI was examined.
RESULTS: Approximately 66.9% were male and 33.1% were female. Baseline ECD was 2802 ± 285 cells/mm2 (1868-3650 cells/mm2). In bivariate correlation analysis, ECD negatively correlated with age (r = -0.19, P < 0.01); final "D" (r = -0.25, P < 0.01); and PETP (r = -0.23, P < 0.01). ECD was positively correlated with ARC (r = 0.20, P < 0.01) and MinCT (r = 0.19, P < 0.01). ECD significantly decreased with age (β = -8.89, P < 0.01), with increasing final "D" (β = -8.68, P < 0.01), increasing PETP (β = -1.86, P < 0.01), decreasing ARC (β = 60.95, P < 0.01), and decreasing MinCT (β = 1.33, P < 0.01). Although ECD decreased with increasing disease severity and age, it remained relatively high, with only 1 eye showing an ECD <2000 cell/mm2.
CONCLUSIONS: Increasing keratoconus tomographic severity results in a significant decrease in ECD. However, even in the most advanced stages, the ECD remains within physiological range.