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Investigation of Different Scanning Protocols for 3 Dimensional High-resolution Imaging of the Human Cornea With Optical Coherence Tomography (OCT) - A Pilot Study

Primary Purpose

Corneal Neovascularisation, Keratoconus

Status

Completed

Phase

Phase 2

Locations

Austria

Study Type

Interventional

Intervention

Optical Coherence Tomography

About this trial

This is an interventional basic science trial for Corneal Neovascularisation focused on measuring Optical Coherence Tomography, Cornea, Imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy volunteers:

Men and women aged over 18 years
Normal findings in the slit lamp examination, no corneal pathologies

Patients with keratoconus:

Men and women aged over 18 years
Presence of keratoconus
No ophthalmic surgery in the 3 months preceding the study

Patients with corneal neovascularization:

Men and women aged over 18 years
Presence of corneal neovascularization
No ophthalmic surgery in the 3 months preceding the study

Exclusion Criteria:

Participation in a clinical trial in the previous 3 weeks
Presence of any abnormalities preventing reliable measurements as judged by the investigator
Pregnancy, planned pregnancy or lactating

Sites / Locations

Department of Clinical Pharmacology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

Healthy volunteers

Corneal Neovascularisation

Keratoconus

Arm Description

10 healthy volunteers

5 patients with corneal neovascularisation

5 patients with keratoconus

Outcomes

Primary Outcome Measures

Corneal Imaging

Development of a measurement protocol for 3 dimensional imaging of the human cornea

Secondary Outcome Measures

Imaging of corneal pathologies

Application of the protocol in patients with corneal pathologies

Full Information

NCT ID

NCT01843101

First Posted

April 26, 2013

Last Updated

August 31, 2021

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT01843101

Brief Title

Investigation of Different Scanning Protocols for 3 Dimensional High-resolution Imaging of the Human Cornea With Optical Coherence Tomography (OCT) - A Pilot Study

Official Title

Investigation of Different Scanning Protocols for 3 Dimensional High-resolution Imaging of the Human Cornea With Optical Coherence Tomography (OCT) - A Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

March 14, 2014 (Actual)

Primary Completion Date

October 24, 2016 (Actual)

Study Completion Date

October 24, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Vienna

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The aim of the present study is to develop a protocol for optimal corneal 3-dimensional imaging based on measurements in healthy volunteers. For this purpose, a customized ultra-high resolution Spectral Domain OCT will be used. To validate whether the protocol can also be applied in patients with corneal pathologies, for whom it is intended to be used, measurements in these patients will be performed. We propose to obtain images from patients with keratoconus, since this is one of the most frequent causes for corneal transplantations in Europe and from patients with corneal neovascularization which is a major cause of vision loss in several ophthalmic diseases. Based on the obtained measurement protocol, further studies investigating the pathophysiology or treatment success of several corneal pathologies can be planned.

6. Conditions and Keywords

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

Corneal Neovascularisation, Keratoconus

Keywords

Optical Coherence Tomography, Cornea, Imaging

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Healthy volunteers

Arm Type

Other

Arm Description

10 healthy volunteers

Arm Title

Corneal Neovascularisation

Arm Type

Other

Arm Description

5 patients with corneal neovascularisation

Arm Title

Keratoconus

Arm Type

Other

Arm Description

5 patients with keratoconus

Intervention Type

Device

Intervention Name(s)

Optical Coherence Tomography

Intervention Description

Imaging of the cornea using ultrahigh resolution Spectral Domain OCT

Primary Outcome Measure Information:

Title

Corneal Imaging

Description

Development of a measurement protocol for 3 dimensional imaging of the human cornea

Time Frame

1 day

Secondary Outcome Measure Information:

Title

Imaging of corneal pathologies

Description

Application of the protocol in patients with corneal pathologies

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy volunteers: Men and women aged over 18 years Normal findings in the slit lamp examination, no corneal pathologies Patients with keratoconus: Men and women aged over 18 years Presence of keratoconus No ophthalmic surgery in the 3 months preceding the study Patients with corneal neovascularization: Men and women aged over 18 years Presence of corneal neovascularization No ophthalmic surgery in the 3 months preceding the study Exclusion Criteria: Participation in a clinical trial in the previous 3 weeks Presence of any abnormalities preventing reliable measurements as judged by the investigator Pregnancy, planned pregnancy or lactating

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Katarzyna Napora, MD, PhD

Organizational Affiliation

Department of Clinical Pharmacology, Medical University of Vienna

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Clinical Pharmacology

City

Vienna

ZIP/Postal Code

1090

Country

Austria

12. IPD Sharing Statement

Learn more about this trial

Investigation of Different Scanning Protocols for 3 Dimensional High-resolution Imaging of the Human Cornea With Optical Coherence Tomography (OCT) - A Pilot Study

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