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

Not Applicable

Completed

• Conditions: Trochlear Nerve Diseases
• Interventions: Device: Heidelberg Spectralis OCT device

• Registration Number: NCT02631369
• Lead Sponsor: University of Zurich

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-09
• Study First Submitted QC: 2015-12-11
• Study First Posted: 2015-12-16
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-11
• Last Update Posted: 2018-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cyclotorsion in healthy subjects	Heidelberg Spectralis OCT 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
inter- & intrarater reliability study	Heidelberg Spectralis OCT device	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
cyclotorsion in forth nerve palsy	Heidelberg Spectralis OCT 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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Zurich, Dept of Ophthalmology; 🇨🇭 Zurich, ZH, Switzerland