search
Back to results

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

Primary Purpose

Trochlear Nerve Diseases

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Heidelberg Spectralis OCT device
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Trochlear Nerve Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital Zurich, Dept of Ophthalmology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

inter- & intrarater reliability study

cyclotorsion in forth nerve palsy

cyclotorsion in healthy subjects

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

pre-study: reliability of repeated measurements of excyclotorsion in degrees on SLO-fundus fotographs
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
study: excyclotorsion in degrees on SLO-fundus fotographs
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

Secondary Outcome Measures

study: excyclotorsion in degrees on tangent screen, double maddox and fundus photographs
validation of the cyclotorsion measurement with the Heidelberg Spectralis device against tangent screen [degrees], double maddox [degrees] and fundus photographs [degrees]

Full Information

First Posted
December 9, 2015
Last Updated
June 11, 2018
Sponsor
University of Zurich
search

1. Study Identification

Unique Protocol Identification Number
NCT02631369
Brief Title
Measuring Cyclotorsion on Scanning Laser Ophthalmoscopy (SLO)-Fundus Photographs
Acronym
CySLO
Official Title
Measuring Cyclotorsion on Scanning Laser Ophthalmoscopy (SLO)-Fundus Photographs Using the Integrated Algorithm by Heidelberg Spectralis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trochlear Nerve Diseases

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
inter- & intrarater reliability study
Arm Type
Experimental
Arm Description
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
Arm Title
cyclotorsion in forth nerve palsy
Arm Type
Experimental
Arm Description
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
Arm Title
cyclotorsion in healthy subjects
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Heidelberg Spectralis OCT device
Primary Outcome Measure Information:
Title
pre-study: reliability of repeated measurements of excyclotorsion in degrees on SLO-fundus fotographs
Description
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
Time Frame
3 months
Title
study: excyclotorsion in degrees on SLO-fundus fotographs
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
study: excyclotorsion in degrees on tangent screen, double maddox and fundus photographs
Description
validation of the cyclotorsion measurement with the Heidelberg Spectralis device against tangent screen [degrees], double maddox [degrees] and fundus photographs [degrees]
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ghislaine L Traber, MD
Organizational Affiliation
University Hospital Zurich, Dept of Ophthalmology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Dept of Ophthalmology
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
28765146
Citation
Lengwiler F, Rappoport D, Jaggi GP, Landau K, Traber GL. Reliability of Cyclotorsion measurements using Scanning Laser Ophthalmoscopy imaging in healthy subjects: the CySLO study. Br J Ophthalmol. 2018 Apr;102(4):535-538. doi: 10.1136/bjophthalmol-2017-310396. Epub 2017 Aug 1.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs