NCT04383366

Brief Summary

To compare repeatability, reproducibility and agreement of both, AS- OCT and Scheimpflug imaging, for the measurement of corneal curvature and corneal thickness in patients with keratoconus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

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

Study Start

First participant enrolled

October 21, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

May 7, 2020

Last Update Submit

March 2, 2021

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (1)

  • maximum K-value

    1 day

Secondary Outcomes (4)

  • Simulated minimum and maximum K-value

    1 day

  • Mean K-values

    1 day

  • Central Corneal thickness

    1 day

  • Thinnest corneal point

    1 day

Study Arms (1)

Patients with keratoconus

Device: Pentacam® (Oculus, Inc., Wetzlar, Germany)Device: Casia II (Tomey Germany, Nürnberg)Device: Spectralis Anterion (Heidelberg Engineering, Heidelberg, Germany)

Interventions

Pentacam® (Oculus, Inc., Wetzlar, Germany)DEVICE

Scheimpflug imaging

Patients with keratoconus
Casia II (Tomey Germany, Nürnberg)DEVICE

Anterior segment optical coherence tomography

Patients with keratoconus
Spectralis Anterion (Heidelberg Engineering, Heidelberg, Germany)DEVICE

Anterior segment optical coherence tomography

Patients with keratoconus

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

50 patients with keratoconus will be recruited in the outpatient department of the Department of Ophthalmology.

You may qualify if:

  • Men and women aged between 18 and 99 years
  • Presence of keratoconus
  • Signed informed consent

You may not qualify if:

  • Contact lens history within 5 days
  • Pathologic changes of the lid or conjunctiva on slit-lamp examination
  • History of corneal ocular surgery/Previous corneal cross-linking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna, Department of Ophthalmology

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Officials

  • Gerald Schmidinger, Prof.Dr.

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof.Dr.

Study Record Dates

First Submitted

May 7, 2020

First Posted

May 12, 2020

Study Start

October 21, 2019

Primary Completion

February 6, 2020

Study Completion

February 6, 2020

Last Updated

March 3, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)