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NCT Number: NCT01843101

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

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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Key information

Conditions

Corneal Neovascularisation Corneal Diseases Corneal Neovascularization Eye Diseases Keratoconus Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Clinical Pharmacology

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

optical coherence tomography

Device

Imaging of the cornea using ultrahigh resolution Spectral Domain OCT

Primary outcomes

  1. Corneal Imaging

    Time frame: 1 day

    Development of a measurement protocol for 3 dimensional imaging of the human cornea

Secondary outcomes

  1. Imaging of corneal pathologies

    Time frame: 1 day

    Application of the protocol in patients with corneal pathologies

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 30, 2013
Registry last updated
Sep 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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