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

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT01843101

Collaborator

(none)

Enrollment

Location

Arms

31.4

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Corneal Neovascularisation Keratoconus	Device: Optical Coherence Tomography	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

Mar 14, 2014

Actual Primary Completion Date :

Oct 24, 2016

Actual Study Completion Date :

Oct 24, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

Other: Healthy volunteers

10 healthy volunteers

Device: Optical Coherence Tomography

Imaging of the cornea using ultrahigh resolution Spectral Domain OCT

Other: Corneal Neovascularisation

5 patients with corneal neovascularisation

Device: Optical Coherence Tomography

Imaging of the cornea using ultrahigh resolution Spectral Domain OCT

Other: Keratoconus

5 patients with keratoconus

Device: Optical Coherence Tomography

Imaging of the cornea using ultrahigh resolution Spectral Domain OCT

Outcome Measures

Primary Outcome Measures

Corneal Imaging [1 day]
Development of a measurement protocol for 3 dimensional imaging of the human cornea

Secondary Outcome Measures

Imaging of corneal pathologies [1 day]
Application of the protocol in patients with corneal pathologies

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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