NCT03184610

Brief Summary

The OCT used in this trial offers the advantage of both a non-contact method and a very high axial resolution. Determined parameters with the highest potential of diagnostic discrimination between eyes with Keratoconus and healthy eyes are investigated. Aim of this trial is to investigate differences of specific parameters of epithelium thickness maps at healthy eyes and eyes with Keratoconus.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2017

Completed
Last Updated

June 12, 2017

Status Verified

June 1, 2017

Enrollment Period

2.5 years

First QC Date

June 9, 2017

Last Update Submit

June 9, 2017

Conditions

Keratoconus

Keywords

KeratoconusOptical Coherence TomographyCorneal Epithelium Thickness Maps

Outcome Measures

Primary Outcomes (1)

  • Corneal Epithelium Thickness

    Parameters collected from epithelium thickness data and maps

    One visit

Study Arms (2)

OCT-scanning

Patients with Keratoconus are scanned with an OCT-Prototype

Device: OCT-scanning

OCT-scanning for volunteers

Volunteers with healthy eyes are scanned with an OCT-Prototype

Device: OCT-scanning

Interventions

OCT-scanningDEVICE

All participants will be scanned with a OCT-device

OCT-scanningOCT-scanning for volunteers

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Eyes with Keratoconus Healthy eyes

You may qualify if:

  • Age\>18
  • Existence of Keratoconus
  • written informed consent obtained

You may not qualify if:

  • Earlier surgery such as PK, CXL, relaxing incisions
  • Systemic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna, Department of Ophthalmology

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass.Prof. PD Dr. Gerald Schmidinger

Study Record Dates

First Submitted

June 9, 2017

First Posted

June 12, 2017

Study Start

December 1, 2014

Primary Completion

June 1, 2017

Last Updated

June 12, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)