NCT01843101

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2013

Completed
11 months until next milestone

Study Start

First participant enrolled

March 14, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2016

Completed
Last Updated

September 8, 2021

Status Verified

August 1, 2021

Enrollment Period

2.6 years

First QC Date

April 26, 2013

Last Update Submit

August 31, 2021

Conditions

Corneal NeovascularisationKeratoconus

Keywords

Optical Coherence TomographyCorneaImaging

Outcome Measures

Primary Outcomes (1)

  • Corneal Imaging

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

    1 day

Secondary Outcomes (1)

  • Imaging of corneal pathologies

    1 day

Study Arms (3)

Healthy volunteers

OTHER

10 healthy volunteers

Device: Optical Coherence Tomography

Corneal Neovascularisation

OTHER

5 patients with corneal neovascularisation

Device: Optical Coherence Tomography

Keratoconus

OTHER

5 patients with keratoconus

Device: Optical Coherence Tomography

Interventions

Optical Coherence TomographyDEVICE

Imaging of the cornea using ultrahigh resolution Spectral Domain OCT

Corneal NeovascularisationHealthy volunteersKeratoconus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Pharmacology

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Corneal NeovascularizationKeratoconusCorneal Diseases

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Eye DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Katarzyna Napora, MD, PhD

    Department of Clinical Pharmacology, Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. PD Dr.

Study Record Dates

First Submitted

April 26, 2013

First Posted

April 30, 2013

Study Start

March 14, 2014

Primary Completion

October 24, 2016

Study Completion

October 24, 2016

Last Updated

September 8, 2021

Record last verified: 2021-08

Locations

AU(1)