Are There Different Objective Fixation Disparity Values f... | NCT02735278

Studies
Are There Different Objective Fixation Disparity Values for Two Different Test Paradigms

NCT02735278

Sponsor

University of Applied Sciences and Arts Northwestern Switzerland

Status

Completed

Last Update Posted

Jan 12, 2017Estimated

Enrollment

24Actual

Phase

Not provided

Conditions

Vision Disparity

Interventions

different test paradigms

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016

Primary Completion Date

Jan 2017Actual

Completion Date

Jan 2017Actual

First Submitted Date

Mar 23, 2016

First Submission Date that Met QC Criteria

Apr 6, 2016

First Posted Date

Apr 12, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2017

Last Update Posted Date

Jan 12, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Remo Poffa, M.Sc Vision Science (Optometry), University of Applied Sciences and Arts Northwestern SwitzerlandPrincipal Investigator

Lead Sponsor

University of Applied Sciences and Arts Northwestern SwitzerlandOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In optometry, binocular coordination is measured subjectively. The result is subjective fixation disparity. In research different experiments have proven, that subjective and objective fixation disparity are different. A binocular eyetracker has to be calibrated. There are two well known calibration methods: associated and dissociated calibration. Objective fixation disparity is measured in arcMin. Therefore, the precision of the eyetracker plays a crucial role. Now, the investigators try to compare dissociated calibration with polarized filters and associated calibration under different test paradigms.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Name	Type	Description	Arm Group Labels	Other Names
different test paradigms	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fixation disparity in arcMin during a reading and reading related dot paradigm	With an eyetracker fixation disparity will be measured on an objective way. The scale will be arcMin and test paradigm a reading tast and a dot task, similar to reading.	Through study completion, up to 10 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

VA without glasses/contact lenses 0.63
Accurate accommodation on 57cm

Exclusion Criteria:

Tiredness at day of investigation
Presbyopia
Alcohol or drug abuse
No eye related pathology
No strabism
No known epilepsy-attack in family

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

Adults without binocular problems

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided