Distinguishing Healthy and Keratoconic Eyes Using Ultrahigh-Resolution OCT

NCT ID: NCT03184610

Last Updated: 2017-06-12

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

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Brief Summary

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

The OCT used in this trial offers the advantage of both a non-contact method and a very high axial resolution. Determined parameters with the highest potential of diagnostic discrimination between eyes with Keratoconus and healthy eyes are investigated. Aim of this trial is to investigate differences of specific parameters of epithelium thickness maps at healthy eyes and eyes 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_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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

OCT-scanning

Patients with Keratoconus are scanned with an OCT-Prototype

OCT-scanning

Intervention Type DEVICE

All participants will be scanned with a OCT-device

OCT-scanning for volunteers

Volunteers with healthy eyes are scanned with an OCT-Prototype

OCT-scanning

Intervention Type DEVICE

All participants will be scanned with a OCT-device

Interventions

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

OCT-scanning

All participants will be scanned with a OCT-device

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* Age\>18
* Existence of Keratoconus
* written informed consent obtained

Exclusion Criteria

* Earlier surgery such as PK, CXL, relaxing incisions
* Systemic diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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

Gerald Schmidinger

Ass.Prof. PD Dr. Gerald Schmidinger

Responsibility Role PRINCIPAL_INVESTIGATOR

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.

1160/2014

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

Retinal Investigation Using Optos OCT Device
NCT06846151 NOT_YET_RECRUITING NA
Dual Wavelength OCT
NCT03843840 COMPLETED
Adaptive Optics Retinal Imaging
NCT02317328 RECRUITING
Peripheral Retina Robotically Aligned OCT Study
NCT06451068 NOT_YET_RECRUITING NA