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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

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Medical University of Vienna

Status and phase

Completed
Phase 2

Conditions

Keratoconus
Corneal Neovascularisation

Treatments

Device: Optical Coherence Tomography

Study type

Interventional

Funder types

Other

Identifiers

NCT01843101
OPHT-040413

Details and patient eligibility

About

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.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

13 participants in 3 patient groups

Healthy volunteers
Other group
Description:
10 healthy volunteers
Treatment:
Device: Optical Coherence Tomography
Corneal Neovascularisation
Other group
Description:
5 patients with corneal neovascularisation
Treatment:
Device: Optical Coherence Tomography
Keratoconus
Other group
Description:
5 patients with keratoconus
Treatment:
Device: Optical Coherence Tomography

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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