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Transepithelial Customized Cross-linking

Primary Purpose

Keratoconus

Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Cross-linking
Sponsored by
Ophthalmica Eye Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring keratoconus, cross-linking, transepithelial, oxygen-boosted, customized, CXL

Eligibility Criteria

12 Years - 55 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Ophthalmica Eye Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Customized, transepithelial cross-linking

Arm Description

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

Outcomes

Primary Outcome Measures

Spectacle-corrected distance visual acuity
Measurements will be performed on Early Treatment of Diabetic Retinopathy Study charts in logMAR units
Kmax
Maximal corneal keratometric value measured on Scheimpflung corneal tomography

Secondary Outcome Measures

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.
Thinnest corneal pachymetry
Values as indicated on Scheimpflung corneal tomography device
Maximal anterior & posterior elevation
Values as indicated on the Belin Ambrosio Enhanced Ectasia module of the Scheimpflung tomography device
Fourier analysis-calculated maximum decentration
Values as indicated on the Fourier analysis module of the Scheimpflung tomography device
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.

Full Information

First Posted
March 25, 2021
Last Updated
March 25, 2021
Sponsor
Ophthalmica Eye Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04820608
Brief Title
Transepithelial Customized Cross-linking
Official Title
Epithelium-on Customized Cross-linking for Keratoconus
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ophthalmica Eye Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
Keywords
keratoconus, cross-linking, transepithelial, oxygen-boosted, customized, CXL

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Customized, transepithelial cross-linking
Arm Type
Experimental
Arm Description
All study patients will be treated according to the customized remodeled vision protocol
Intervention Type
Device
Intervention Name(s)
Cross-linking
Other Intervention Name(s)
Customized remodeled vision
Intervention Description
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.
Primary Outcome Measure Information:
Title
Spectacle-corrected distance visual acuity
Description
Measurements will be performed on Early Treatment of Diabetic Retinopathy Study charts in logMAR units
Time Frame
1-3-6 months, 1 year, 2 years
Title
Kmax
Description
Maximal corneal keratometric value measured on Scheimpflung corneal tomography
Time Frame
1-3-6 months, 1 year, 2 years
Secondary Outcome Measure Information:
Title
Demarcation line depth
Description
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.
Time Frame
1 month
Title
Thinnest corneal pachymetry
Description
Values as indicated on Scheimpflung corneal tomography device
Time Frame
1-3-6 months, 1 year, 2 years
Title
Maximal anterior & posterior elevation
Description
Values as indicated on the Belin Ambrosio Enhanced Ectasia module of the Scheimpflung tomography device
Time Frame
1-3-6 months, 1 year, 2 years
Title
Fourier analysis-calculated maximum decentration
Description
Values as indicated on the Fourier analysis module of the Scheimpflung tomography device
Time Frame
1-3-6 months, 1 year, 2 years
Title
Regularization index
Description
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.
Time Frame
1-3-6 months, 1 year, 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miltos Balidis, PhD
Organizational Affiliation
Ophthalmica Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ophthalmica Eye Institute
City
Thessaloníki
State/Province
Kalamaria
ZIP/Postal Code
54655
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26944278
Citation
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.
Results Reference
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Transepithelial Customized Cross-linking

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