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Measuring of Neuro-visual Functionality With Ocusweep

Primary Purpose

Visual Impairment

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Ocusweep
Ocusweep OcuRT
Sponsored by
Ocuspecto Oy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Visual Impairment

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy volunteers
  • Persons suffering diagnosed eye disease
  • Persons suffering diagnosed brain disease

Exclusion Criteria:

  • No diabetes
  • Only one diagnosed disease

Sites / Locations

  • Ocuspecto OyRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

LEA numbers, Pelli-Robson, Octopus

Arm Description

Comparable generally used method for measuring visual acuity, contrast sensitivity and visual field.

Outcomes

Primary Outcome Measures

Visual acuity
Visual acuity is measured as logMAR unit at the one visit for each patient using a novel reaction-time based visual field device and comparable method.

Secondary Outcome Measures

Contrast sensitivity
Contrast sensitivity is measured as logCS unit at the one visit for each patient using a novel reaction-time based visual field device and comparable method.
Reaction time visual field
Reaction time is measured using a novel reaction-time based visual field device and compared with generally used visual field program.
Vision based choice reaction time
Reaction time is measured with Ocusweep OcuRT test three times to asses repeatability of the test. OcuRT reaction time results will be compared to Trail Making Test (TMT), Useful Field of View (UFOV) and Vienna Test System (VTS) reaction time tests. To evaluate the ability to detect unreliable results, OcuRT will also be done under cognitive load and with instructions to cheat the test.

Full Information

First Posted
September 30, 2014
Last Updated
June 15, 2020
Sponsor
Ocuspecto Oy
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1. Study Identification

Unique Protocol Identification Number
NCT02258113
Brief Title
Measuring of Neuro-visual Functionality With Ocusweep
Official Title
Measuring of Neuro-visual Functionality With New Human Visual System Device Ocusweep
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ocuspecto Oy

4. Oversight

5. Study Description

Brief Summary
The aim of this study is to measure visual acuity, contrast sensitivity and visual field by SAP-method using a novel device Ocusweep compared to currently widely used methods. Addition to that, the aim is to validate a novel perimetry method (Visual Search Test, VST) which is based on reaction times in visual decision- making task, where the subject is allowed to move eyes and where the fixation is verified by the subject himself in contrast to standard automatic perimetry (SAP) where prolonged stationary fixation and external fixation monitoring apparatus is required. Reaction-time based visual field device Ocusweep is compared to generally used SAP methods. Those tests will be done for healthy volunteers and for persons with diagnosed eye or brain disease. Ocusweep OcuRT vision based choice reaction time test is validated for test repeatability and compared to Trail Making Test (TMT), Useful Field of View (UFOV) and Vienna Test System (VTS) reaction time tests. To evaluate the ability to detect unreliable results, OcuRT test is also done under cognitive load and with instructions to cheat the test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Impairment

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LEA numbers, Pelli-Robson, Octopus
Arm Type
Other
Arm Description
Comparable generally used method for measuring visual acuity, contrast sensitivity and visual field.
Intervention Type
Device
Intervention Name(s)
Ocusweep
Intervention Description
A novel reaction-time based visual field device.
Intervention Type
Device
Intervention Name(s)
Ocusweep OcuRT
Intervention Description
Vision based choice reaction time test method
Primary Outcome Measure Information:
Title
Visual acuity
Description
Visual acuity is measured as logMAR unit at the one visit for each patient using a novel reaction-time based visual field device and comparable method.
Time Frame
One visit per one patient (1h/visit)
Secondary Outcome Measure Information:
Title
Contrast sensitivity
Description
Contrast sensitivity is measured as logCS unit at the one visit for each patient using a novel reaction-time based visual field device and comparable method.
Time Frame
One visit per one patient (1h/visit)
Title
Reaction time visual field
Description
Reaction time is measured using a novel reaction-time based visual field device and compared with generally used visual field program.
Time Frame
One visit per one patient (1h/visit)
Title
Vision based choice reaction time
Description
Reaction time is measured with Ocusweep OcuRT test three times to asses repeatability of the test. OcuRT reaction time results will be compared to Trail Making Test (TMT), Useful Field of View (UFOV) and Vienna Test System (VTS) reaction time tests. To evaluate the ability to detect unreliable results, OcuRT will also be done under cognitive load and with instructions to cheat the test.
Time Frame
One visit per one test subject (1h/visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteers Persons suffering diagnosed eye disease Persons suffering diagnosed brain disease Exclusion Criteria: No diabetes Only one diagnosed disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Markku Leinonen, Dr
Email
markku.leinonen@ocuspecto.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jaakko Suominen, MSc
Email
jaakko.suominen@ocuspecto.com
Facility Information:
Facility Name
Ocuspecto Oy
City
Turku
ZIP/Postal Code
20100
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markku Leinonen, PhD
Email
markku.leinonen@ocuspecto.com
First Name & Middle Initial & Last Name & Degree
Jaakko Suominen, MSc
Email
jaakko.suominen@ocuspecto.com

12. IPD Sharing Statement

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Measuring of Neuro-visual Functionality With Ocusweep

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