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

NCT ID: NCT02631369

Last Updated: 2018-06-13

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-12-31

Brief Summary

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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

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Conditions

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Trochlear Nerve Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Heidelberg Spectralis OCT device

Intervention Type DEVICE

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

Group Type EXPERIMENTAL

Heidelberg Spectralis OCT device

Intervention Type DEVICE

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

Group Type EXPERIMENTAL

Heidelberg Spectralis OCT device

Intervention Type DEVICE

Interventions

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Heidelberg Spectralis OCT device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ghislaine L Traber, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Dept of Ophthalmology

Locations

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University Hospital Zurich, Dept of Ophthalmology

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 28765146 (View on PubMed)

Other Identifiers

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KEK-ZH-Nr. 2014-0404

Identifier Type: -

Identifier Source: org_study_id

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