Visual ImpairmentNCT02258113
Measuring of Neuro-visual Functionality With Ocusweep
A study testing Ocusweep and Ocusweep OcuRT in people with Visual Impairment, run by Ocuspecto Oy at 1 site in Finland.
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… Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Impairment
- What is being tested?
- Ocusweep and Ocusweep OcuRT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteFinland
- Study dates
- Nov 2014to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Persons suffering diagnosed eye disease
- Persons suffering diagnosed brain disease
Who cannot join
- No diabetes
- Only one diagnosed disease
Trial locations and contacts
1 site in 1 country.
Markku Leinonen, Dr contact
Jaakko Suominen, MSc contact
Finland1 site, 1 recruiting
- Recruiting
Ocuspecto Oy
Turku, 20100
Markku Leinonen, PhD, markku.leinonen@ocuspecto.com
Jaakko Suominen, MSc, jaakko.suominen@ocuspecto.com
About this study
Official title: Measuring of Neuro-visual Functionality With New Human Visual System Device Ocusweep
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.
- Conditions
- Visual Impairment
- Being tested
- Ocusweep, Ocusweep OcuRT
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OcusweepDevice
A novel reaction-time based visual field device.
Ocusweep OcuRTDevice
Vision based choice reaction time test method
| Study group | Role | What they receive |
|---|---|---|
| LEA numbers, Pelli-Robson, Octopus | Other | Comparable generally used method for measuring visual acuity, contrast sensitivity and visual field. Receives: Device: Ocusweep; Device: Ocusweep OcuRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One visit per one patient (1h/visit)
Secondary outcomes (3)
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.
Measured: One visit per one patient (1h/visit)
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.
Measured: One visit per one patient (1h/visit)
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.
Measured: One visit per one test subject (1h/visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ocuspecto Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258113
- Sponsor's protocol ID
- T109/2014
- Status last verified
- Jun 2020
- First submitted
- 30 Sep 2014
- Last updated
- 17 Jun 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring of Neuro-visual Functionality With New Human Visual System Device Ocusweep
- ClinicalTrials.gov ID
- NCT02258113
- Acronym / sponsor ID
- T109/2014
- Conditions
- Visual Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Ocuspecto OyIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 7 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LEA numbers, Pelli-Robson, Octopus | Other | Device: Ocusweep, Device: Ocusweep OcuRTComparable generally used method for measuring visual acuity, contrast sensitivity and visual field. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy volunteers
- Persons suffering diagnosed eye disease
- Persons suffering diagnosed brain disease
Key exclusion criteria (2 listed)
- No diabetes
- Only one diagnosed disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OcusweepA novel reaction-time based visual field device. | Device | LEA numbers, Pelli-Robson, Octopus |
| Ocusweep OcuRTVision based choice reaction time test method | Device | LEA numbers, Pelli-Robson, Octopus |
Primary outcome
Visual acuity
Time frame: 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.
3 secondary outcomes
Contrast sensitivity
Time frame: One visit per one patient (1h/visit)
Reaction time visual field
Time frame: One visit per one patient (1h/visit)
Vision based choice reaction time
Time frame: One visit per one test subject (1h/visit)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markku Leinonen, Dr contact
Jaakko Suominen, MSc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ocusweep and Ocusweep OcuRT in people with Visual Impairment, run by Ocuspecto Oy at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Markku Leinonen, Dr (markku.leinonen@ocuspecto.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: One visit per one patient (1h/visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020.