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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-14

Study Completion Date

2016-10-24

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.

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Detailed Description

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Conditions

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Corneal Neovascularisation Keratoconus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy volunteers

10 healthy volunteers

Group Type OTHER

Optical Coherence Tomography

Intervention Type DEVICE

Imaging of the cornea using ultrahigh resolution Spectral Domain OCT

Corneal Neovascularisation

5 patients with corneal neovascularisation

Group Type OTHER

Optical Coherence Tomography

Intervention Type DEVICE

Imaging of the cornea using ultrahigh resolution Spectral Domain OCT

Keratoconus

5 patients with keratoconus

Group Type OTHER

Optical Coherence Tomography

Intervention Type DEVICE

Imaging of the cornea using ultrahigh resolution Spectral Domain OCT

Interventions

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Optical Coherence Tomography

Imaging of the cornea using ultrahigh resolution Spectral Domain OCT

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes