Measuring of Neuro-visual Functionality With Ocusweep

Visual Impairment Clinical Trial

Official title:

Measuring of Neuro-visual Functionality With New Human Visual System Device Ocusweep

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02258113
• Other study ID #: T109/2014
• Status: Recruiting
• Phase: N/A
• Start date: November 2014
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2020
• Source: Ocuspecto Oy
• Contact: Markku Leinonen, Dr
• Email: markku.leinonen[@]ocuspecto.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers

• Persons suffering diagnosed eye disease

• Persons suffering diagnosed brain disease

Exclusion Criteria:

• No diabetes

• Only one diagnosed disease

Related Conditions & MeSH terms

• Vision Disorders
• Vision, Low
• Visual Impairment

Intervention

Device:
• Ocusweep
A novel reaction-time based visual field device.
• Ocusweep OcuRT
Vision based choice reaction time test method

Locations

Country	Name	City	State
Finland	Ocuspecto Oy	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Ocuspecto Oy

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One visit per one patient (1h/visit)
Secondary	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.	One visit per one patient (1h/visit)
Secondary	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.	One visit per one patient (1h/visit)
Secondary	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.	One visit per one test subject (1h/visit)