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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Corneal Neovascularisation, Keratoconus

Intervention / Treatment
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* Device: Optical Coherence Tomography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy volunteers<br>10 healthy volunteers | Device: Optical Coherence Tomography<br>* Imaging of the cornea using ultrahigh resolution Spectral Domain OCT<br>|
| Other: Corneal Neovascularisation<br>5 patients with corneal neovascularisation | Device: Optical Coherence Tomography<br>* Imaging of the cornea using ultrahigh resolution Spectral Domain OCT<br>|
| Other: Keratoconus<br>5 patients with keratoconus | Device: Optical Coherence Tomography<br>* Imaging of the cornea using ultrahigh resolution Spectral Domain OCT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Imaging | Development of a measurement protocol for 3 dimensional imaging of the human cornea | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Imaging of corneal pathologies | Application of the protocol in patients with corneal pathologies | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Optical Coherence Tomography, Cornea, Imaging