Transepithelial Customized Cross-linking

Epithelium-on Customized Cross-linking for Keratoconus

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Keratoconus
• Intervention / Treatment: Device: Cross-linking

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Kalamaria
    • Thessaloníki, Kalamaria, Greece, 54655
      • Ophthalmica Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Customized, transepithelial cross-linking; All study patients will be treated according to the customized remodeled vision protocol	Device: 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.; Other Names: Customized remodeled vision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spectacle-corrected distance visual acuity	Measurements will be performed on Early Treatment of Diabetic Retinopathy Study charts in logMAR units	1-3-6 months, 1 year, 2 years
Kmax	Maximal corneal keratometric value measured on Scheimpflung corneal tomography	1-3-6 months, 1 year, 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demarcation line depth	Measurements will be performed at 1st postoperative month, when the demarcation line is most visible, on anterior segment optical coherence tomography. The measurement will be performed manually on the scan approximating the thinnest corneal location with the device-native caliper set at 1:1μm.	1 month
Thinnest corneal pachymetry	Values as indicated on Scheimpflung corneal tomography device	1-3-6 months, 1 year, 2 years
Maximal anterior & posterior elevation	Values as indicated on the Belin Ambrosio Enhanced Ectasia module of the Scheimpflung tomography device	1-3-6 months, 1 year, 2 years
Fourier analysis-calculated maximum decentration	Values as indicated on the Fourier analysis module of the Scheimpflung tomography device	1-3-6 months, 1 year, 2 years
Regularization index	Regularization index was proposed by Seiler et al. The measurement will be performed using the maximum flattening and steepening on the Comparison display of the Scheimpflung tomography device.	1-3-6 months, 1 year, 2 years

Collaborators and Investigators

• Sponsor: Ophthalmica Eye Institute
• Investigators: Principal Investigator: Miltos Balidis, PhD, Ophthalmica Eye Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2021
• Last Update Submitted That Met QC Criteria: March 25, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: keratoconus; cross-linking; transepithelial; oxygen-boosted; customized; CXL
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratoconus
• Other Study ID Numbers: OphthalmicaEI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No