Evaluation of personalized contact lens for corneal collagen cross-linking therapy in keratoconus

The National Eye Institute awarded The University of North Texas Health Science Center at Fort Worth $402,439 on April 1, 2026, to evaluate a personalized, UV-absorbing contact lens for corneal collagen cross-linking therapy in keratoconus patients.

Keratoconus is a progressive corneal disorder that can lead to corneal transplantation or vision loss if untreated. Collagen cross-linking (CXL) is an FDA-approved treatment that stiffens corneal tissue, but it is not viable for patients with corneal thickness below 400 micrometers due to potential endothelial damage from UV exposure. Contact-lens-assisted CXL has emerged as an alternative for such patients, though current approaches using commercially available contact lenses soaked with riboflavin provide only fixed UV attenuation (approximately 90 micrometers) irrespective of individual corneal thickness variation, limiting treatment efficacy and introducing procedural variability.

The funded research addresses this unmet need by developing a novel contact lens that is itself UV-absorbing, thickness-controlled, and riboflavin-loaded to provide personalized UV attenuation matched to patient-specific corneal thickness. The research team, consisting of a corneal biologist and a bioengineer, has established a 3D-printing protocol for a biopolymer-based, contact-lens-shaped hydrogel with precise control over geometrical parameters and will evaluate this clinical application based on preliminary data.

The award is funded under the Vision Research program (CFDA 93.867), which supports research to understand the eye and visual system, prevent and treat vision diseases, and expand opportunities for people who are blind or require vision rehabilitation. The period of performance runs from April 1, 2026, through March 31, 2029, with work performed in Fort Worth, Texas.

Abstract

Keratoconus (KC) is a progressive corneal disorder characterized by several clinical presentations, including steepening and thinning of the cornea, that can ultimately lead to corneal transplantation or vision loss if untreated. Collagen cross-linking (CXL) is an FDA-approved treatment, where DE-epithelialized cornea is absorbed with riboflavin and exposed to ultraviolet (UV) light to cross-link and stiffen collagenous stroma. Unfortunately, CXL is not a viable option for KC patients with corneal thickness below 400 ΜM due to potential damage in the underlying endothelium from UV exposure. Contact-lens (CL) assisted CXL (CACXL) has been proposed as a novel procedure for such patients, where a commercially available contact lens soaked with riboflavin is placed over the stroma pre-wetted with riboflavin eye drops to temporarily provide UV attenuation via the retention of UV-absorbing riboflavin layer (adding approximately 90 ΜM). While CACXL procedure is safer, the fixed thickness (-90 ΜM) of the riboflavin films hinders the CXL performance by limiting UV attenuation to a constant magnitude irrespective of the wide spectrum of KC patients' cornea thickness. Moreover, unmeasurable loss of riboflavin from eye drops and non-standardized procedure for preparing CL-soaked riboflavin add to the variability in CXL treatment across patients. To address this critical unmet need to advance CXL treatment and expand its eligibility to a broader patient population, we propose a novel contact lens that is itself UV-absorbing, thickness-controlled, and riboflavin-loaded. Our multidisciplinary team consisting of a corneal biologist and a bioengineer have previously established an optimal 3D-printing protocol for a biopolymerbased, contact lens-shaped hydrogel with precise control over its geometrical parameters. Based on the preliminary data, we will evaluate the clinical translatability of our customizable ultra violet T, ttenuating construct (CUVAC)S fabricated in a range of thicknesses to meet the requirements of the patient based on the individual's corneal thickness. In aim 1, we will rigorously test the reproducibility of CUVAC fabrication and storage process by characterizing their function-critical properties. In aim 2, we will determine the CXL outcome of each CUVAC with defined thickness utilizing enucleated rabbit eye. Lastly in aim 3, we will assess in vitro and in vivo safety of CUVAC. We believe this innovative ocular device will bring direct clinical impact by admitting currently ineligible KC patients to CXL therapy,