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

Trochlear Nerve Diseases Clinical Trial

— CySLO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02631369
• Other study ID #: KEK-ZH-Nr. 2014-0404
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: December 2017

Study information

• Verified date: June 2018
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nervous System Diseases
• Trochlear Nerve Diseases

Intervention

Device:
• Heidelberg Spectralis OCT device

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Dept of Ophthalmology	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months
Primary	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	12 months
Secondary	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]	12 months