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

Keratoconus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01843101
• Other study ID #: OPHT-040413
• Status: Completed
• Phase: Phase 2
• Start date: March 14, 2014
• Est. completion date: October 24, 2016

Study information

• Verified date: August 2021
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: October 24, 2016
• Est. primary completion date: October 24, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Corneal Neovascularisation
• Corneal Neovascularization
• Keratoconus
• Neovascularization, Pathologic

Intervention

Device:
• Optical Coherence Tomography
Imaging of the cornea using ultrahigh resolution Spectral Domain OCT

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal Imaging	Development of a measurement protocol for 3 dimensional imaging of the human cornea	1 day
Secondary	Imaging of corneal pathologies	Application of the protocol in patients with corneal pathologies	1 day