Macular DegenerationNCT02747368
Evaluation of Visual Function and Driving Health Using Ocusweep in Patients Suffering From Wet Age-related Macular Degeneration
A study testing Ocusweep system in people with Macular Degeneration, run by Turku University Hospital.
Trial summary
The aim is to study the use of Ocusweep system especially in driving health evaluation and compare the results produced by Ocusweep system to those of conventional devices. The main focus is in patients suffering from wet age-related macular degeneration. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- Ocusweep system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Apr 2021
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Macular degeneration or other diagnosed or suspected macular disease
Who cannot join
- Pregnancy
- Mental disorder
- Dementia and Alzheimers disease
- Prisoners
About this study
The aim is to study the use of Ocusweep system especially in driving health evaluation and compare the results produced by Ocusweep system to those of conventional devices. The main focus is in patients suffering from wet age-related macular degeneration. The study aims to find out how frequently these patients do not meet the European Union health criteria of safe driving and how Ocusweep finds these patients from a population of patients being treated in a busy medical retina clinic. The tests of Ocusweep system are compared against conventional visual field tests, contrast sensitivity tests, visual acuity tests and tests showing anatomical changes related to wet age-related macular degeneration (optical coherence tomography, fundus photography and fluorescein or indocyanine green angiography).
- Conditions
- Macular Degeneration
- Being tested
- Ocusweep system
- Keywords
- Wet age-related macular degeneration, Age-related macular degeneration, Ocusweep, Driving health, Visual field, Contrast sensitivity
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocusweep systemDevice
Comparison of Ocusweep system to conventional visual acuity, contrast sensitivity and visual field testing.
| Study group | Role | What they receive |
|---|---|---|
| Wet age related macular degeneration | Other | Ocusweep system is compared to results of conventional devices. Receives: Device: Ocusweep system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by absolute scotoma in central visual field
Measured: 2 years
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by narrowing of peripheral visual field
Measured: 2 years
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by visual acuity score
Measured: 2 years
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by contrast sensitivity score
Measured: 2 years
Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results acquired by central visual field testing
Measured: 4 years
Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results acquired by peripheral visual field testing
Measured: 4 years
Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results in visual acuity scores
Measured: 4 years
Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results in contrast sensitivity score
Measured: 4 years
Evidence which (Ocusweep or ophthalmologist) is better in finding patients not meeting health criteria for driving, by comparison of results acquired by central visual field testing
Measured: 2 years
Evidence which (Ocusweep or ophthalmologist) is better in finding patients not meeting health criteria for driving, by comparison of results acquired by peripheral visual field testing
Measured: 2 years
Evidence which (Ocusweep or ophthalmologist) is better in finding patients not meeting health criteria for driving, by comparison of results in visual acuity scores
Measured: 2 years
Evidence which (Ocusweep or ophthalmologist) is better in finding patients not meeting health criteria for driving, by comparison of results in contrast sensitivity score
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Vesa Aaltonen, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747368
- Sponsor's protocol ID
- T220/2015
- Status last verified
- Apr 2017
- First submitted
- 8 Apr 2016
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Visual Function and Driving Health Using Ocusweep in Patients Suffering From Wet Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT02747368
- Acronym / sponsor ID
- T220/2015
- Conditions
- Macular Degeneration
- Keywords
- Wet age-related macular degeneration, Age-related macular degeneration, Ocusweep, Driving health, Visual field, Contrast sensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Apr 2016
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 21 Apr 2016 (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 is to study the use of Ocusweep system especially in driving health evaluation and compare the results produced by Ocusweep system to those of conventional devices. The main focus is in patients suffering from wet age-related macular degeneration. The study aims to find out how frequently these patients do not meet the European Union health criteria of safe driving and how Ocusweep finds these patients from a population of patients being treated in a busy medical retina clinic. The tests of Ocusweep system are compared against conventional visual field tests, contrast sensitivity tests, visual acuity tests and tests showing anatomical changes related to wet age-related macular degeneration (optical coherence tomography, fundus photography and fluorescein or indocyanine green angiography).
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wet age related macular degeneration | Other | Device: Ocusweep systemOcusweep system is compared to results of conventional devices. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Macular degeneration or other diagnosed or suspected macular disease
Key exclusion criteria (4 listed)
- Pregnancy
- Mental disorder
- Dementia and Alzheimers disease
- Prisoners
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 |
|---|---|---|
| Ocusweep systemComparison of Ocusweep system to conventional visual acuity, contrast sensitivity and visual field testing. | Device | Wet age related macular degeneration |
Primary outcome
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by absolute scotoma in central visual field
Time frame: 2 years
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by narrowing of peripheral visual field
Time frame: 2 years
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by visual acuity score
Time frame: 2 years
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by contrast sensitivity score
Time frame: 2 years
Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results acquired by central visual field testing
Time frame: 4 years
Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results acquired by peripheral visual field testing
Time frame: 4 years
Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results in visual acuity scores
Time frame: 4 years
Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results in contrast sensitivity score
Time frame: 4 years
Evidence which (Ocusweep or ophthalmologist) is better in finding patients not meeting health criteria for driving, by comparison of results acquired by central visual field testing
Time frame: 2 years
Evidence which (Ocusweep or ophthalmologist) is better in finding patients not meeting health criteria for driving, by comparison of results acquired by peripheral visual field testing
Time frame: 2 years
Evidence which (Ocusweep or ophthalmologist) is better in finding patients not meeting health criteria for driving, by comparison of results in visual acuity scores
Time frame: 2 years
Evidence which (Ocusweep or ophthalmologist) is better in finding patients not meeting health criteria for driving, by comparison of results in contrast sensitivity score
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ocusweep system in people with Macular Degeneration, run by Turku University Hospital.
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 1 inclusion and 4 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 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by absolute scotoma in central visual field (time frame: 2 years). The study lists 12 primary outcomes in all. 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 26 Apr 2017; AzTrials last refreshed its copy on 30 Oct 2026.