Measuring of Neuro-visual Functionality With Ocusweep
1 other identifier
interventional
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2014
CompletedFirst Posted
Study publicly available on registry
October 7, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedJune 17, 2020
June 1, 2020
7.1 years
September 30, 2014
June 15, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Contrast sensitivity
One visit per one patient (1h/visit)
Reaction time visual field
One visit per one patient (1h/visit)
Vision based choice reaction time
One visit per one test subject (1h/visit)
Study Arms (1)
LEA numbers, Pelli-Robson, Octopus
OTHERComparable generally used method for measuring visual acuity, contrast sensitivity and visual field.
Interventions
Eligibility Criteria
You may qualify if:
- Healthy volunteers
- Persons suffering diagnosed eye disease
- Persons suffering diagnosed brain disease
You may not qualify if:
- No diabetes
- Only one diagnosed disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ocuspecto Oylead
Study Sites (1)
Ocuspecto Oy
Turku, 20100, Finland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2014
First Posted
October 7, 2014
Study Start
November 1, 2014
Primary Completion
December 1, 2021
Study Completion
December 31, 2022
Last Updated
June 17, 2020
Record last verified: 2020-06