Agreement and Accuracy of Different Devices Corneal Measurements

NCT ID: NCT04383366

Last Updated: 2021-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-21

Study Completion Date

2020-02-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Keratoconus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with keratoconus

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

Intervention Type DEVICE

Scheimpflug imaging

Casia II (Tomey Germany, Nürnberg)

Intervention Type DEVICE

Anterior segment optical coherence tomography

Spectralis Anterion (Heidelberg Engineering, Heidelberg, Germany)

Intervention Type DEVICE

Anterior segment optical coherence tomography

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Scheimpflug imaging

Intervention Type DEVICE

Casia II (Tomey Germany, Nürnberg)

Anterior segment optical coherence tomography

Intervention Type DEVICE

Spectralis Anterion (Heidelberg Engineering, Heidelberg, Germany)

Anterior segment optical coherence tomography

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gerald Schmidinger

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gerald Schmidinger

Prof.Dr.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gerald Schmidinger, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical University of Vienna, Department of Ophthalmology

Vienna, , Austria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TOPOC

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Enhancing Scleral Lens Fit With Advanced Imaging
NCT06751615 ENROLLING_BY_INVITATION