Transepithelial Customized Cross-linking

Ophthalmica Eye Institute

Status: Unknown

Conditions: Keratoconus

Treatments: Device: Cross-linking

Study type: Interventional

Funder types: Other

Identifiers

NCT04820608

OphthalmicaEI

Details and patient eligibility

About

Customized remodeled vision (CuRV) is a new corneal cross-linking protocol for keratoconus, combining a transepithelial approach with customized energy application. Our aim is to follow-up our patients and establish the short-and long-term results of CuRV.

Full description

Customized remodeled vision is a protocol for oxygen-boosted, tranespithelial cross-linking, customized to apply higher energy at the apex of the cone, relatively lower to the cone area and none to healthy cornea. Thus CuRV promises to halt keratoconus progression, simultaneously offering potential for relatively good visual rehabilitation.Our primary outcomes involve spectacle-corrected distance visual acuity and changes in corneal topography/tomography and OCT parameters. These parameters include Kmax, thinnest corneal pachymetry, maximal anterior and posterior elevation, the Fourier analysis-derived irregularity index, and demarcation line depth.

Enrollment: 50 estimated patients

Sex: All

Ages: 12 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Topographic evidence of keratoconus:
• maximum corneal curvature (Kmax) ≥47.00 D,
• localized steepening on topographic maps,
• localized elevation in the anterior and posterior corneal surfaces.

Exclusion criteria

• Hypersensitivity to riboflavin
• Thinnest corneal pachymetry < 380 μm
• History of corneal surgery, including previous cross-linking
• Corneal scarring
• Aphakia
• Pseudophakia
• Any visually significant ocular condition

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Customized, transepithelial cross-linking

Experimental group

Description:

All study patients will be treated according to the customized remodeled vision protocol

Treatment:

Device: Cross-linking