Transepithelial Customized Cross-linking
Epithelium-on Customized Cross-linking for Keratoconus
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2018
CompletedFirst Submitted
Initial submission to the registry
March 25, 2021
CompletedFirst Posted
Study publicly available on registry
March 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedMarch 29, 2021
March 1, 2021
3.9 years
March 25, 2021
March 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
Demarcation line depth
1 month
Thinnest corneal pachymetry
1-3-6 months, 1 year, 2 years
Maximal anterior & posterior elevation
1-3-6 months, 1 year, 2 years
Fourier analysis-calculated maximum decentration
1-3-6 months, 1 year, 2 years
Regularization index
1-3-6 months, 1 year, 2 years
Study Arms (1)
Customized, transepithelial cross-linking
EXPERIMENTALAll study patients will be treated according to the customized remodeled vision protocol
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ophthalmica Eye Institute
Thessaloniki, Kalamaria, 54655, Greece
Related 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.
PMID: 26944278BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Miltos Balidis, PhD
Ophthalmica Eye Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2021
First Posted
March 29, 2021
Study Start
February 1, 2018
Primary Completion
January 1, 2022
Study Completion
January 1, 2022
Last Updated
March 29, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share