Can Immune Modulators Help In Stabilizing Keratoconus: An Algorithmic Approach

Keratoconus (KC) is a progressive, inflammatory ectatic disease characterized by corneal thinning and biomechanical weakening, often associated with elevated inflammatory biomarkers. This study evaluates the role of biomarkers in KC progression and assesses the potential of immune modulators as a therapeutic strategy for disease stabilization.

A single-center prospective study conducted in a clinical research setting.

A cohort of 350 eyes was divided into two groups: Group 1 (placebo, N = 175) and Group 2 (N = 175), which received targeted biomarker therapy, including trehalose and/or cyclosporine. Tear samples from untreated mild-to-moderate KC eyes were collected using Schirmer’s strips and analyzed for biomarkers using a point-of-care diagnostic kit. Baseline and 8-month follow-up assessments included corneal topography, epithelial and stromal mapping, and collagen imaging.

Progression, defined as an increase in maximum keratometry (Kmax) by ≥1.0 D, steepening of the cornea by ≥1.5 D, a ≥0.75 D myopic shift, an increase in cylinder by ≥1.0 D, or corneal thinning exceeding 10 μm, was observed in 121 eyes in Group 1. These eyes also showed collagen weakening, Bowman’s layer thinning, and persistently elevated inflammatory biomarkers (MMP-9, TNF-α, IL-6). In contrast, Group 2 demonstrated stabilization in 150 eyes, with a mean change in Kmax of 0.99 D ± 0.5 D. This group exhibited improved collagen orientation, stable Bowman’s layer thickness, and a 50-60% reduction in inflammatory biomarkers.

Biomarker-driven therapy plays a crucial role in stabilizing early-to-moderate keratoconus by reducing inflammation and preserving corneal integrity. This novel approach offers promising therapeutic potential for slowing disease progression and improving long-term management.