Transepithelial Customized Cross-linking

Keratoconus Clinical Trial

Official title:

Epithelium-on Customized Cross-linking for Keratoconus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04820608
• Other study ID #: OphthalmicaEI
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: January 1, 2022

Study information

• Verified date: March 2021
• Source: Ophthalmica Eye Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Keratoconus

Intervention

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.

Locations

Country	Name	City	State
Greece	Ophthalmica Eye Institute	Thessaloníki	Kalamaria

Sponsors (1)

Lead Sponsor	Collaborator
Ophthalmica Eye Institute

Country where clinical trial is conducted

Greece, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Kmax	Maximal corneal keratometric value measured on Scheimpflung corneal tomography	1-3-6 months, 1 year, 2 years
Secondary	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
Secondary	Thinnest corneal pachymetry	Values as indicated on Scheimpflung corneal tomography device	1-3-6 months, 1 year, 2 years
Secondary	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
Secondary	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
Secondary	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