Transepithelial Customized Cross-linking

NCT ID: NCT04820608

Last Updated: 2021-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2022-01-01

Brief Summary

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.

Detailed 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.

Conditions

Keratoconus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Customized, transepithelial cross-linking

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

Group Type: EXPERIMENTAL

Cross-linking

Intervention Type: DEVICE

Oxygen-boosted, epithelium-on, customized cross-linking. Highest UV-A application is focused on the apex of the cone. The cone area receives a moderate amount of UV-A, while healthy cornea is spared.

Interventions

Cross-linking

Oxygen-boosted, epithelium-on, customized cross-linking. Highest UV-A application is focused on the apex of the cone. The cone area receives a moderate amount of UV-A, while healthy cornea is spared.

Intervention Type: DEVICE

Other Intervention Names

Customized remodeled vision

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ophthalmica Eye Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miltos Balidis, PhD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmica Eye Institute

Locations

Ophthalmica Eye Institute

Thessaloniki, Kalamaria, Greece

Countries

Greece

References

Seiler TG, Fischinger I, Koller T, Zapp D, Frueh BE, Seiler T. Customized Corneal Cross-linking: One-Year Results. Am J Ophthalmol. 2016 Jun;166:14-21. doi: 10.1016/j.ajo.2016.02.029. Epub 2016 Mar 2.

Reference Type: BACKGROUND

PMID: 26944278 (View on PubMed)

Other Identifiers

OphthalmicaEI

Identifier Type: -

Identifier Source: org_study_id