Visual ImpairmentPVTSNCT03141164
Peripheral Vision Training Study
A study testing computerized training in people with Visual Impairment and Cognitive Change, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study will train participants (young people and older adults) to do a visual task, and will assess whether this results in changes in behavioral assessments. In some participants, we will be also testing whether MRI measures (cortical thickness, functional connectivity) change with training. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Impairment, Cognitive Change
- What is being tested?
- computerized training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2017to 30 Sep 2020
- 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 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Right handed individuals
- Aged 19-89
- In good health as self-reported or visual impairments due to partial vision loss
- Normal or corrected-to-normal vision with contact lenses or visual impairments due to partial vision loss
Who cannot join
- Younger than 18 or older than 89
- Being hearing-impaired
- Not in good health except due to partial vision loss
- Having a previous serious head injury or neurological disorder, or loss of consciousness for more than 2 minutes
- Having hallucinations or delusions
- Having a current or past history of a substance abuse disorder
- Currently taking psychoactive medications
Trial locations and contacts
1 site in 1 country.
About this study
This study will train participants (young people and older adults) to do a visual task, and will assess whether this results in changes in behavioral assessments. In some participants, we will be also testing whether MRI measures (cortical thickness, functional connectivity) change with training.
- Conditions
- Visual Impairment, Cognitive Change
- Being tested
- computerized training
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computerized trainingOther
Computerized training
| Study group | Role | What they receive |
|---|---|---|
| Training | Experimental | Computerized vision training Receives: Other: computerized training |
| Control | Sham comparator | Sham Receives: Other: computerized training |
What is being measured
The primary outcome is the main question the study is designed to answer.
scores on acuity tests
scores on acuity tests
Measured: baseline
scores on acuity tests
scores on acuity tests
Measured: immediately following training
scores on spatial attention tests
scores on spatial attention tests
Measured: baseline
scores on spatial attention tests
scores on spatial attention tests
Measured: immediately following training
Secondary outcomes (2)
Changes in cortical thickness
Increases in cortical thickness in areas corresponding to trained visual field
Measured: baseline and immediately following training
Changes in functional connectivity
Changes in functional connectivity of areas corresponding to trained visual field
Measured: baseline and immediately following training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start30 May 2017
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
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.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina M Visscher, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141164
- Sponsor's protocol ID
- X101022014
- Acronym
- PVTS
- Status last verified
- Jun 2021
- First submitted
- 28 Apr 2017
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Vision Training Study
- ClinicalTrials.gov ID
- NCT03141164
- Acronym / sponsor ID
- PVTS / X101022014
- Conditions
- Visual Impairment, Cognitive Change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 30 May 2017 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 4 May 2017 (actual)
- 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.
This study will train participants (young people and older adults) to do a visual task, and will assess whether this results in changes in behavioral assessments. In some participants, we will be also testing whether MRI measures (cortical thickness, functional connectivity) change with training.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training | Experimental | Other: computerized trainingComputerized vision training |
| Control | Sham comparator | Other: computerized trainingSham |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Right handed individuals
- Aged 19-89
- In good health as self-reported or visual impairments due to partial vision loss
- Normal or corrected-to-normal vision with contact lenses or visual impairments due to partial vision loss
Key exclusion criteria (7 listed)
- Younger than 18 or older than 89
- Being hearing-impaired
- Not in good health except due to partial vision loss
- Having a previous serious head injury or neurological disorder, or loss of consciousness for more than 2 minutes
- Having hallucinations or delusions
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 |
|---|---|---|
| computerized trainingComputerized training | Other | Control, Training |
Primary outcome
scores on acuity tests
Time frame: baseline
scores on acuity tests
scores on acuity tests
Time frame: immediately following training
scores on acuity tests
scores on spatial attention tests
Time frame: baseline
scores on spatial attention tests
scores on spatial attention tests
Time frame: immediately following training
scores on spatial attention tests
2 secondary outcomes
Changes in cortical thickness
Time frame: baseline and immediately following training
Changes in functional connectivity
Time frame: baseline and immediately following training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computerized training in people with Visual Impairment and Cognitive Change, run by University of Alabama at Birmingham at 1 site in United States.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 8 Jun 2021. 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 United States. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
scores on acuity tests (time frame: baseline). The study lists 4 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 8 Jun 2021.