Assessment of Cyclofusion Capabilities of Normal Subjects and Patients With 3D Dynamic Random-dot Stereograms

With this study the investigator wants measure the individual cyclofusion competence from healthy subjects and patients suffering from Strabismus with a only binocularly visible threedimensional Landolt-C stimulus. For this the participant has to look at a 3-D monitor with shutter glasses. The participant is sitting in 2 meter distance in front of the monitor. On the monitor appears the Landolt-C stimulus as a dynamic Random-Dot Stimulus. As long as the participant can fuse the stimulus he will be able to see the Landolt C-ring threedimensional. The participant is then ask to tell in which direction the notch of the Landolt-C ring points out. Once a critical degree of cyclotorsion is reached the participant will no longer be able to see the Landolt C ring and the individual cyclofusion competence is reached.

Study Overview

• Status: Unknown
• Conditions: Cyclofusion Competence
• Intervention / Treatment: Diagnostic test: measurement of the cyclofusion

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Visual acuity >0,4; Stereopsis

Exclusion Criteria:

• Visual acuity <0,4; no Stereopsis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cyclofusion	Diagnostic test: measurement of the cyclofusion; Measurement of the maximal cyclofusion competence with a dynamic 3-D Random-Dot Landolt-C stimulus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In- and excyclofusion competence in healthy individuals. Change in In- and excyclofusion competence in patients who need a strabismus surgery before and 6 month after surgery.	The maximum in- and maximum excyclofusion competence will be measured with the described test set-up. The results will be documented in degree.	Once in healthy individuals. Before and 6 month after a (independent from the study) performed strabismus surgery.

Collaborators and Investigators

• Sponsor: Cantonal Hospital of St. Gallen

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2018
• Primary Completion (ANTICIPATED): April 20, 2019
• Study Completion (ANTICIPATED): April 20, 2019

Study Registration Dates

• First Submitted: October 6, 2017
• First Submitted That Met QC Criteria: October 23, 2017
• First Posted (ACTUAL): October 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 26, 2017
• Last Update Submitted That Met QC Criteria: October 23, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2016-02118

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No