Epithelial Thickness Map

NCT04578184 | Unknown

• 1 other identifier: Epithelial thickness map
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

In keratoconic eyes, the corneal epithelium shows a localized thinning over the cone that is surrounded by an annulus of epithelial thickening. It has been postulated that epithelial thickness mapping can be a sensitive tool for the keratoconus diagnosis. In keratoconus screening the 5 mm diameter of the corneal centrum may be sufficient while studies have shown that the cone apex is located in this area. Aim of this study is to assess agreement and repeatability of epithelial thickness measurements using two optical coherence tomography devices in healthy and keratoconus corneas. Secondary objective is to evaluate the differences between healthy and keratoconus eyes using epithelial thickness map data. This is a prospective monocentric study that includes patients divided into two groups: patients with keratoconus and a control group formed out of patients without corneal pathologies. For each patient only one eye will be included and corneal measurements will be performed, focused on the corneal epithelium thickness.

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (1)

• Agreement between two ss-OCT devices in corneal epithelial thickness measurements (LoA in micrometer)

  6 months

Secondary Outcomes (1)

• Repeatability between two ss-OCT devices in corneal epithelial thickness measurements (determination of within-subject standard deviation and Coefficient of variation)

  6 months

Study Arms (2)

Epithelial thickness map evaluation in keratoconus patients

OTHER

Patients included in the study will be measured with the corneal acquisition mode, also allowing for epithelium thickness data, on each device without pupil dilatation Each patient will be measured three times with both devices. The corneal epithelial thickness will be measured as the distance between the air-tear and the epithelium-Bowman interfaces.

Diagnostic Test: Corneal epithelial thickness measurements

Epithelial thickness map evaluation in healthy cornea patients

OTHER

Patients included in the study will be measured with the corneal acquisition mode, also allowing for epithelium thickness data, on each device without pupil dilatation Each patient will be measured three times with both devices. The corneal epithelial thickness will be measured as the distance between the air-tear and the epithelium-Bowman interfaces.

Diagnostic Test: Corneal epithelial thickness measurements

Interventions

Corneal epithelial thickness measurements DIAGNOSTIC_TEST

Corneal epithelial thickness measurements using two optical coherence tomography devices in healthy and keratoconus corneas.

Epithelial thickness map evaluation in healthy cornea patients; Epithelial thickness map evaluation in keratoconus patients

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with diagnosed keratoconus (diagnosed using tomography and topography map changes and slit-lamp changes) and patients with healthy cornea
• Age 21 and older
• Signed informed consent

You may not qualify if:

• Previous ocular surgery
• Associated corneal pathologies (e.g. trauma, edema, scarring)

Sponsors & Collaborators

• Vienna Institute for Research in Ocular Surgery: lead

Study Sites (1)

Hanusch Hospital, Ophthalmology Department

Vienna, 1140, Austria

RECRUITING

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Oliver Findl, Prof., MD

  Head of Department of Ophthalmology, Professor, Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oliver Findl, Prof., MD

CONTACT

+43 1 91021-84611; hkh.augen.abt@wgkk.at

Nino Hirnschall, MD, PhD

CONTACT

+43 1 91021 57564; office@viros.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Ophthalmology, Professor, Principal Investigator, MBA

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 8, 2020
• Study Start: October 15, 2020
• Primary Completion: February 1, 2021
• Study Completion: March 1, 2021
• Last Updated: October 12, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)