Measuring of Neuro-visual Functionality With Ocusweep

Not Applicable

• Conditions: Visual Impairment
• Interventions: Device: Ocusweep; Device: Ocusweep OcuRT

• Registration Number: NCT02258113
• Lead Sponsor: Ocuspecto Oy

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-30
• Study First Submitted QC: 2014-10-02
• Study First Posted: 2014-10-07
• Study Start: 2014-11
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-15
• Last Update Posted: 2020-06-17
• Primary Completion: 2021-12
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

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

Exclusion Criteria

• No diabetes
• Only one diagnosed disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LEA numbers, Pelli-Robson, Octopus	Ocusweep	Comparable generally used method for measuring visual acuity, contrast sensitivity and visual field.
LEA numbers, Pelli-Robson, Octopus	Ocusweep OcuRT	Comparable generally used method for measuring visual acuity, contrast sensitivity and visual field.

Primary Outcome Measures

Name	Time	Method
Visual acuity	One visit per one patient (1h/visit)	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

Name	Time	Method
Contrast sensitivity	One visit per one patient (1h/visit)	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	One visit per one patient (1h/visit)	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	One visit per one test subject (1h/visit)	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.

Trial Locations

Locations (1)

Ocuspecto Oy; 🇫🇮 Turku, Finland