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

Award Number: R01EY038524
ORGANIZATION: NATIONAL EYE INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/01/2026
PERIOD OF PERFORMANCE END DATE: 03/31/2029

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


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $402,439 )
2026	2026	THE UNIVERSITY OF NORTH TEXAS HEALTH SCIENCE CENTER AT FORT WORTH	3500 CAMP BOWIE BLVD	FORT WORTH	TX	76107	TARRANT	USA	Vision Research	000	1	4/2/2026	NEW	$402,439
														Subtotal = $402,439

Grand Total All Awards = $402,439

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

Award Number: R01EY038524

ORGANIZATION: NATIONAL EYE INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 04/01/2026

PERIOD OF PERFORMANCE END DATE: 03/31/2029

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