Keratoconus, a condition causing an asymmetry of corneal shape and thickness, poses significant challenges to vision due to progressive thinning, steepening, and irregular astigmatism. With a prevalence of 1% to 4%, it represents a substantial unmet need for noninvasive treatment. Standard approaches, such as contact lenses or corneal ring segments, may fall short as the disease progresses, often leading to the need for corneal transplantation. Since the advent of corneal collagen crosslinking (CXL), there has been a significant breakthrough in slowing ectasia progression.
In a recent study, we investigated the efficacy of EpiSmart epi-on crosslinking, a novel technique designed to enhance patient outcomes. Dr. Randy J. Epstein's study aimed to assess changes in visual acuity after epi-on corneal crosslinking for keratoconus patients. The results are promising and underscore the potential of this innovative approach.
Study Design and Methods
The Phase 2 trial study enrolled subjects with corneal ectatic diseases in a prospective, randomized, controlled, open-label, multicenter design. The subjects were randomized into three treatment groups and treated with the EpiSmart epi-on crosslinking system. The primary endpoint was the logarithm of the minimum angle of resolution corrected distance visual acuity (CDVA), with secondary endpoints including uncorrected distance visual acuity (UCVA), maximum corneal curvature (Kmax), and minimum corneal thickness.
Results and Implications
Out of the 2,228 subjects treated with epi-on crosslinking, 1,922 had a diagnosis of keratoconus. The subjects with keratoconus demonstrated significant improvements in CDVA, UCVA, and Kmax at both 6 and 12 months post-operatively. Notably, minimum corneal thickness remained unchanged. Adverse events were reported in 8.7% of subjects, with a mild corneal epithelial defect being the most common event.
Efficacy and Safety Profile
EpiSmart epi-on crosslinking showcased mean improvements in CDVA, UCVA, and Kmax at both 6 and 12 months, with an excellent safety profile. Only 1.4% of subjects reported a mild corneal epithelial defect as the sole adverse event, and no serious adverse events related to the treatment were observed. This indicates a promising safety and efficacy profile for EpiSmart in treating keratoconus.
Significance for Patients
The study's findings suggest that EpiSmart epi-on crosslinking could be a game-changer in the treatment landscape for keratoconus. The noninvasive nature of the procedure, coupled with its positive impact on visual acuity and corneal curvature, positions EpiSmart as a potential alternative to traditional epi-off crosslinking methods.
Staying At the Forefront of Corneal Care
EpiSmart epi-on crosslinking, as Dr. Randy J. Epstein and the research team investigated, has demonstrated significant improvements in visual acuity and corneal parameters for patients with keratoconus. With a favorable safety profile, this innovative technique holds promise as a transformative approach to address the challenges posed by keratoconus. As further research unfolds, EpiSmart could emerge as a leading option for enhancing the quality of life for individuals grappling with this vision-threatening condition.
Phase 3 of the study is in progress
Study enrollment is currently active, and visits are conducted at both Hoffman Estates & Highland Park Locations. There will be no charge to study participants for their participation in this study. The investigational procedure, study- related procedures, and study visits will be provided at no charge. Possible candidates for epithelium-on cross-linking for keratoconus in individuals 8 to 45 years of age. This study will remain open until enough participants have enrolled. The available spots fill up quickly so please contact us if you have any questions.