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Epithelial Thickness Map

Primary Purpose

Keratoconus

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Corneal epithelial thickness measurements
Sponsored by
Vienna Institute for Research in Ocular Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Keratoconus

Eligibility Criteria

21 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Previous ocular surgery
  • Associated corneal pathologies (e.g. trauma, edema, scarring)
  • In women of childbearing age, a pregnancy test will be performed before inclusion into the study.

Sites / Locations

  • Hanusch Hospital, Ophthalmology DepartmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Epithelial thickness map evaluation in keratoconus patients

Epithelial thickness map evaluation in healthy cornea patients

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 30, 2020
Last Updated
October 7, 2020
Sponsor
Vienna Institute for Research in Ocular Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT04578184
Brief Title
Epithelial Thickness Map
Official Title
Comparison of Two Optical Coherence Tomography Devices in Corneal Epithelial Thickness Maps
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2020 (Anticipated)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vienna Institute for Research in Ocular Surgery

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
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.
Detailed Description
In total 50 eyes of 50 patients will be included, divided into two groups: study group comprised of 20 eyes with diagnosed keratoconus and a control group formed out of 30 healthy eyes. 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. After each measurement patients will be asked to blink in order to allow adequate tear-film recovery. Each patient will be measured three times with both devices. Only one visit will be necessary. The order in which the measurements will be performed (Anterion or MS-39) will be randomised using randomised.org. The corneal epithelial thickness will be measured as the distance between the air-tear and the epithelium-Bowman interfaces. Main outcome variable: - Mean differences in central corneal epithelial thickness between the devices investigated (+ limits of agreement (1.96xSD) between the investigated devices) Secondary outcome variables: Repeatability coefficient (within subject standard deviation - SD) and coefficient of variation of the two devices Comparison in epithelial thickness between normal and keratoconus eyes Sensitivity and specificity of swept-source OCT device in keratoconus diagnosis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Epithelial thickness map evaluation in keratoconus patients
Arm Type
Other
Arm Description
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.
Arm Title
Epithelial thickness map evaluation in healthy cornea patients
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Corneal epithelial thickness measurements
Intervention Description
Corneal epithelial thickness measurements using two optical coherence tomography devices in healthy and keratoconus corneas.
Primary Outcome Measure Information:
Title
Agreement between two ss-OCT devices in corneal epithelial thickness measurements (LoA in micrometer)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Repeatability between two ss-OCT devices in corneal epithelial thickness measurements (determination of within-subject standard deviation and Coefficient of variation)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Previous ocular surgery Associated corneal pathologies (e.g. trauma, edema, scarring) In women of childbearing age, a pregnancy test will be performed before inclusion into the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oliver Findl, Prof., MD
Phone
+43 1 91021-84611
Email
hkh.augen.abt@wgkk.at
First Name & Middle Initial & Last Name or Official Title & Degree
Nino Hirnschall, MD, PhD
Phone
+43 1 91021 57564
Email
office@viros.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, Prof., MD
Organizational Affiliation
Head of Department of Ophthalmology, Professor, Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hanusch Hospital, Ophthalmology Department
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, Prof. MD
Phone
+43 1 91021 57564
Email
office@viros.at

12. IPD Sharing Statement

Plan to Share IPD
No

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Epithelial Thickness Map

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