Transepithelial Customized Cross-linking

Study Overview
=================
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.

Official Title
-----------------
Epithelium-on Customized Cross-linking for Keratoconus

Conditions
-----------------
Keratoconus

Intervention / Treatment
-----------------
* Device: Cross-linking


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Customized, transepithelial cross-linking<br>All study patients will be treated according to the customized remodeled vision protocol | Device: Cross-linking<br>* 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.<br>* 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
keratoconus, cross-linking, transepithelial, oxygen-boosted, customized, CXL