Transepithelial Customized Cross-linking

Not Applicable

• Conditions: Keratoconus
• Interventions: Device: Cross-linking

• Registration Number: NCT04820608
• Lead Sponsor: Ophthalmica Eye Institute

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.

Study Timeline

• Study Start: 2018-02-01
• Status Verified: 2021-03
• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-03-25
• Last Update Submitted: 2021-03-25
• Study First Posted: 2021-03-29
• Last Update Posted: 2021-03-29
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Customized, transepithelial cross-linking	Cross-linking	All study patients will be treated according to the customized remodeled vision protocol

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Maximal anterior & posterior elevation	1-3-6 months, 1 year, 2 years	Values as indicated on the Belin Ambrosio Enhanced Ectasia module of the Scheimpflung tomography device
Demarcation line depth	1 month	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.
Thinnest corneal pachymetry	1-3-6 months, 1 year, 2 years	Values as indicated on Scheimpflung corneal tomography device
Fourier analysis-calculated maximum decentration	1-3-6 months, 1 year, 2 years	Values as indicated on the Fourier analysis module of the Scheimpflung tomography device
Regularization index	1-3-6 months, 1 year, 2 years	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.

Trial Locations

Locations (1)

Ophthalmica Eye Institute; 🇬🇷 Thessaloníki, Kalamaria, Greece