Transepithelial Customized Cross-linking

Sponsor
Ophthalmica Eye Institute (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04820608
Collaborator
(none)
50
1
1
47
1.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Cross-linking
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Epithelium-on Customized Cross-linking for Keratoconus
Actual Study Start Date :
Feb 1, 2018
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Jan 1, 2022

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    2. Kmax [1-3-6 months, 1 year, 2 years]

      Maximal corneal keratometric value measured on Scheimpflung corneal tomography

    Secondary Outcome Measures

    1. 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.

    2. Thinnest corneal pachymetry [1-3-6 months, 1 year, 2 years]

      Values as indicated on Scheimpflung corneal tomography device

    3. 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

    4. 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

    5. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ophthalmica Eye Institute Thessaloníki Kalamaria Greece 54655

    Sponsors and Collaborators

    • Ophthalmica Eye Institute

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ophthalmica Eye Institute
    ClinicalTrials.gov Identifier:
    NCT04820608
    Other Study ID Numbers:
    • OphthalmicaEI
    First Posted:
    Mar 29, 2021
    Last Update Posted:
    Mar 29, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ophthalmica Eye Institute
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 29, 2021