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

Phase 2

Completed

• Conditions: Corneal Neovascularisation; Keratoconus
• Interventions: Device: Optical Coherence Tomography

• Registration Number: NCT01843101
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-04-26
• Study First Submitted QC: 2013-04-29
• Study First Posted: 2013-04-30
• Study Start: 2014-03-14
• Primary Completion: 2016-10-24
• Study Completion: 2016-10-24
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corneal Neovascularisation	Optical Coherence Tomography	5 patients with corneal neovascularisation
Healthy volunteers	Optical Coherence Tomography	10 healthy volunteers
Keratoconus	Optical Coherence Tomography	5 patients with keratoconus

Primary Outcome Measures

Name	Time	Method
Corneal Imaging	1 day	Development of a measurement protocol for 3 dimensional imaging of the human cornea

Secondary Outcome Measures

Name	Time	Method
Imaging of corneal pathologies	1 day	Application of the protocol in patients with corneal pathologies

Trial Locations

Locations (1)

Department of Clinical Pharmacology; 🇦🇹 Vienna, Austria