Low VisionPhase 2NCT00013377
Predictors of Driving Performance and Successful Mobility - Rehabilitation in Patients With Medical Eye Condition
A Phase 2 study testing Low vision in people with Low Vision, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
There are two diseases in particular that may have serious consequences for driving and mobility due to their potentially severe impact on visual function: glaucoma and diabetic neuropathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Vision
- What is being tested?
- Low vision
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1999to Mar 2002
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Eye impairment
Trial locations and contacts
1 site in 1 country.
About this study
There are two diseases in particular that may have serious consequences for driving and mobility due to their potentially severe impact on visual function: glaucoma and diabetic neuropathy. In this project we will develop predictive models of driving for these patients and will train them to use low-vision aids to improve driving mobility. We will determine how best to train patients with hemianopic field loss due to cerebral vascular accidents and identify predictors of long-term success in the use of low-vision aids.
Read the detailed description
There are two diseases in particular that may have serious consequences for driving and mobility due to their potentially severe impact on visual function: glaucoma and diabetic neuropathy. Both these diseases can potentially result in significant peripheral visual field loss, sometimes coupled with decreased visual acuity. We have previously demonstrated that each of these visual losses alone can have significant impact on driving and mobility performance. In this project we will develop predictive models of driving for these patients and apply our extensive expertise in training patients to use low-vision aids to improve driving mobility. A second question that will be addressed is how to best train scanning patients with hemianopic field loss due to cerebral vascular accidents. We propose to configure the prisms in a bioptic form similar to previously used for amorphic lenses in RP and for bioptic telescopes for patients in macular disease. The third problem that will be addressed is the identification of predictors of long-term success in the use of low-vision aids.
- Conditions
- Low Vision
- Being tested
- Low vision
- Keywords
- Low vision, Driving rehabilitation
- Medical subject headings
- Vision, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low visionProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2001 (estimated)
- Study startApr 1999
- Study completionMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low VisionStudies 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 2
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- John Fryer, Ph. D., Asst. Director, Program Analysis and Review Section (PARS), Rehabilitation Research & Development ServiceNancy Rocheleau, Program Analyst, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00013377
- Sponsor's protocol ID
- C1982R
- Status last verified
- Jan 2001
- First submitted
- 14 Mar 2001
- Last updated
- 21 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Driving Performance and Successful Mobility - Rehabilitation in Patients With Medical Eye Condition
- ClinicalTrials.gov ID
- NCT00013377
- Acronym / sponsor ID
- C1982R
- Conditions
- Low Vision
- Keywords
- Low vision, Driving rehabilitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Apr 1999
- Study completion
- Mar 2002 (actual)
- First posted
- 16 Mar 2001 (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.
There are two diseases in particular that may have serious consequences for driving and mobility due to their potentially severe impact on visual function: glaucoma and diabetic neuropathy. In this project we will develop predictive models of driving for these patients and will train them to use low-vision aids to improve driving mobility. We will determine how best to train patients with hemianopic field loss due to cerebral vascular accidents and identify predictors of long-term success in the use of low-vision aids.
Detailed description
There are two diseases in particular that may have serious consequences for driving and mobility due to their potentially severe impact on visual function: glaucoma and diabetic neuropathy. Both these diseases can potentially result in significant peripheral visual field loss, sometimes coupled with decreased visual acuity. We have previously demonstrated that each of these visual losses alone can have significant impact on driving and mobility performance. In this project we will develop predictive models of driving for these patients and apply our extensive expertise in training patients to use low-vision aids to improve driving mobility. A second question that will be addressed is how to best train scanning patients with hemianopic field loss due to cerebral vascular accidents. We propose to configure the prisms in a bioptic form similar to previously used for amorphic lenses in RP and for bioptic telescopes for patients in macular disease. The third problem that will be addressed is the identification of predictors of long-term success in the use of low-vision aids.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Low vision | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 21 Jan 2009.
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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.
John Fryer, Ph. D., Asst. Director
Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
Nancy Rocheleau, Program Analyst
Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low vision in people with Low Vision, run by US Department of Veterans Affairs 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?
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 21 Jan 2009. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 21 Jan 2009.