Measuring Cyclotorsion on Scanning Laser Ophthalmoscopy (SLO)-Fundus Photographs (CySLO)

June 11, 2018 updated by: University of Zurich

Measuring Cyclotorsion on Scanning Laser Ophthalmoscopy (SLO)-Fundus Photographs Using the Integrated Algorithm by Heidelberg Spectralis

Pre-Study: Evaluation of the inter- and intrarater reliability of the integrated algorithm by Heidelberg Spectralis for measuring cyclotorsion on SLO-fundus fotographs, and assessment of the influence of measuring with or without eye tracker.

Study: Comparison of cyclotorsion measurements in patients with forth nerve palsy and in healthy controls on SLO-fundus fotographs using the integrated algorithm by Heidelberg Spectralis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, 8091
        • University Hospital Zurich, Dept of Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥ 18 years old
  • best corrected visual acuity ≥ 0.8

Exclusion Criteria:

  • strabismus except for forth nerve palsy
  • previous strabismus surgery
  • monocle
  • best corrected visual acuity ≤ 0.6
  • hyperopia or myopia > 6dpt

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: inter- & intrarater reliability study
pre-study: inter- and intrarater reliability study in 30 healthy subjects, interventions: SLO-fundus photographs using the integrated algorithm by Heidelberg Spectralis OCT (optical coherence tomography) device
Device: Heidelberg Spectralis OCT device
Experimental: cyclotorsion in forth nerve palsy
measurement of cyclotorsion on SLO-fundusphoto in 20 patients forth nerve palsy interventions: SLO-fundus photographs using the integrated algorithm by Heidelberg Spectralis OCT (optical coherence tomography) device
Device: Heidelberg Spectralis OCT device
Experimental: cyclotorsion in healthy subjects
measurement of cyclotorsion on SLO-fundusphoto in 30 healthy subjects to be compared to patients with forth nerve palsy interventions: SLO-fundus photographs using the integrated algorithm by Heidelberg Spectralis OCT (optical coherence tomography) device
Device: Heidelberg Spectralis OCT device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pre-study: reliability of repeated measurements of excyclotorsion in degrees on SLO-fundus fotographs
Time Frame: 3 months
pre-study: inter- and intrarater reliability of the device with or without eye tracker; excyclotorsion in degrees (based on the line crossing the fovea and the center of the optic nerve head) as provided by the integrated algorithm by Heidelberg Spectralis
3 months
study: excyclotorsion in degrees on SLO-fundus fotographs
Time Frame: 12 months
study: comparison of cyclotorsion measurements in healthy controls compared to patients with forth nerve palsy; excyclotorsion in degrees (based on the line crossing the fovea and the center of the optic nerve head) as provided by the integrated algorithm by Heidelberg Spectralis
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
study: excyclotorsion in degrees on tangent screen, double maddox and fundus photographs
Time Frame: 12 months
validation of the cyclotorsion measurement with the Heidelberg Spectralis device against tangent screen [degrees], double maddox [degrees] and fundus photographs [degrees]
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Ghislaine L Traber, MD, University Hospital Zurich, Dept of Ophthalmology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

December 9, 2015

First Submitted That Met QC Criteria

December 11, 2015

First Posted (Estimate)

December 16, 2015

Study Record Updates

Last Update Posted (Actual)

June 13, 2018

Last Update Submitted That Met QC Criteria

June 11, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK-ZH-Nr. 2014-0404

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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