Low VisionNCT02310880
Efficacy of Enhancing Low Vision Mobility Thru Visual Training in Virtual World
An observational study of Low Vision, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Low vision patients have difficulty acquiring sufficient visual information in a timely manner for the purpose of performing challenging daily tasks, such as traveling independently and safely through busy streets. Read more about this study
- Who is it for?
- Ages 19 to 81 years
- Conditions the study is for
- Low Vision
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Mar 2015
- Phase
- Observational
- 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 19 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Low vision participants will be recruited from the patient populations of the Clinics of UAB School of Optometry and UAB Center for Low Vision Rehabilitation
Who may be able to join
- Ambulatory and have independent traveling as one of their rehabilitation goals.
- Participants with central field loss should have best corrected binocular visual acuity between 20/200 and 20/1000, but with relatively intact peripheral visual field (>80o).
- Participants with peripheral visual field loss should have >20/63 visual acuity and no more than 20 deg diameter but not less than 8 deg diameter visual field in the better eye.
Who cannot join
- Participants who have a mixture of central and peripheral field loss.
- Previous or current recipient of O\&M training.
- Participants who have plans to receive O\&M training during the study period.
- Age younger than 19 or older than 81.
- Significant cognitive impairment as determined with the Short Portable Mental Status Questionnaire (≥2 errors); inability to understand and speak English.
- Severe hearing impairment that interferes with interactions with O\&M specialists.
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- Inability or unwillingness to make visits required by the study.
- Not living in the Birmingham-Jefferson county area.
- Persons who have a history of epilepsy or who are prone to motion sickness or simulator aftereffect, determined by an epileptic seizure history inquiry and a Motion Sickness History Questionnaire.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Clinical Eye Research Facility
Birmingham, Alabama, 35294
About this study
Low vision patients have difficulty acquiring sufficient visual information in a timely manner for the purpose of performing challenging daily tasks, such as traveling independently and safely through busy streets. The advance of virtual reality techniques has provided a potential platform for training low vision patients to use their remaining vision more efficiently, but the key issue is always whether the patient's visual experiences in a virtual world can be transferred to the real world. The proposed study is designed to provide definite answer to this question.
Read the detailed description
NEI's National Plan for Eye and Vision Research has identified Low Vision and Blindness Rehabilitation as one of the most pressing needs and opportunities in vision research. Since most low vision (LV) patients nowadays have useable vision, an important aspect of LV rehabilitation is to maximize the use of the patient's remaining vision. Visual skills are especially important in tasks such as traveling independently through busy streets, in which distant, rapidly changing events have direct impact on the patient's task efficiency and safety. The patient has to learn new information acquisition skills to compensate for their impaired vision. Current LV training for such skills is done on real streets in a one-on-one, trainer/trainee sessions. This way of training, however, usually does not expose clients to all the circumstances that they need to deal with, usually does not provide graded levels of task difficulty and repeatable conditions that facilitate learning, and cannot meet the needs of the majority of LV patients because of the shortage and the high cost of LV trainers. The advances of virtual reality (VR) technology have made it possible and affordable to realistically simulate complex and dynamic visual and auditory environments to facilitate LV rehabilitation. However, the most important first step in applying VR technologies to LV rehabilitation is to determine whether the visual experiences of a LV person can be transferred to the real world. Only when a positive transfer of visual skills is confirmed, can subsequent development of comprehensive VR training systems for all aspects of LV rehabilitation become worthwhile. The purpose of this study is to accomplish this first step. A set of visual skills for a most visually challenging task, crossing a signal-controlled street, is selected from standard orientation and mobility curriculum to study virtual experience transfer. Existing technology are used to build a desktop computer-based VR simulator that can generate virtual street intersection scenarios that contain visual and auditory information required for practicing the skills to be studied. Computer generated street intersections with pedestrians, traffic and control signals are projected to a large screen for the participant to view, like a movie. Twenty LV persons are recruited from a university LV rehabilitation facility. They are randomly assigned to practicing the selected visual skills at real or virtual street intersections. Their skill levels are evaluated at real intersections before and immediately after their scheduled training. The primary outcome of interest is the mean change of visual skills between pre- and post-training evaluations in the two groups. The training is not a rehabilitation intervention because only the changes in visual/audio information gathering skills are trained and observed. The participants are trained and evaluated on the sidewalks of the real and virtual street. They are never allowed to step down the curb to avoid exposure to any danger. The long-term goal is to develop interactive VR training systems that have multiple sensory and motor input and output modules and that incorporate the collective experiences of the LV rehabilitation profession. Adding such systems to LV curriculum can greatly improve the affordability, accessibility, efficiency and the scope of LV rehabilitation.
- Conditions
- Low Vision
- Medical subject headings
- Vision, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Low vision (virtual street training) | Low vision subjects trained in virtual streets and observed in real streets | |
| Low vision (real street training) | Low vision subjects trained in real streets and observed in real streets |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of dangerous street crossing decisions and the street crossing decision safety scores
The percentage of dangerous street crossing decisions is determined at real street corners during pre- and post-training evaluation sessions. The subject is asked to say "GO" when she feels it is the safest time to cross the street. A crossing decision is scored as dangerous if it is initiated in the red traffic light cycle or if there is < 25% of the "WALK" cycle left. The percentage is the total number of dangerous decisions divided by the total number of crossing decisions made during one evaluation session. The safety of a crossing decision is further quantified by recording the decision timing using a stopwatch and by converting the recorded time to a safety score. The safety score is a continuous scale between 0 and 1.0. The larger the safety score, the safer is the crossing decision. A statistically significant reduction in the percentage dangerous crossing decisions and an increase in the safety scores after training is an indication of successful skill learning and transfer.
Measured: 3-5 1-hour visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startSep 2010
- Primary completionMar 2015
- Study completionMar 2015
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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lei Liu, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310880
- Sponsor's protocol ID
- X100716003
- Status last verified
- Dec 2014
- First submitted
- 3 Dec 2014
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Enhancing Low Vision Mobility Thru Visual Training in Virtual World
- ClinicalTrials.gov ID
- NCT02310880
- Acronym / sponsor ID
- X100716003
- Conditions
- Low Vision
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 8 Dec 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.
Low vision patients have difficulty acquiring sufficient visual information in a timely manner for the purpose of performing challenging daily tasks, such as traveling independently and safely through busy streets. The advance of virtual reality techniques has provided a potential platform for training low vision patients to use their remaining vision more efficiently, but the key issue is always whether the patient's visual experiences in a virtual world can be transferred to the real world. The proposed study is designed to provide definite answer to this question.
Detailed description
NEI's National Plan for Eye and Vision Research has identified Low Vision and Blindness Rehabilitation as one of the most pressing needs and opportunities in vision research. Since most low vision (LV) patients nowadays have useable vision, an important aspect of LV rehabilitation is to maximize the use of the patient's remaining vision. Visual skills are especially important in tasks such as traveling independently through busy streets, in which distant, rapidly changing events have direct impact on the patient's task efficiency and safety. The patient has to learn new information acquisition skills to compensate for their impaired vision. Current LV training for such skills is done on real streets in a one-on-one, trainer/trainee sessions. This way of training, however, usually does not expose clients to all the circumstances that they need to deal with, usually does not provide graded levels of task difficulty and repeatable conditions that facilitate learning, and cannot meet the needs of the majority of LV patients because of the shortage and the high cost of LV trainers. The advances of virtual reality (VR) technology have made it possible and affordable to realistically simulate complex and dynamic visual and auditory environments to facilitate LV rehabilitation. However, the most important first step in applying VR technologies to LV rehabilitation is to determine whether the visual experiences of a LV person can be transferred to the real world. Only when a positive transfer of visual skills is confirmed, can subsequent development of comprehensive VR training systems for all aspects of LV rehabilitation become worthwhile. The purpose of this study is to accomplish this first step. A set of visual skills for a most visually challenging task, crossing a signal-controlled street, is selected from standard orientation and mobility curriculum to study virtual experience transfer. Existing technology are used to build a desktop computer-based VR simulator that can generate virtual street intersection scenarios that contain visual and auditory information required for practicing the skills to be studied. Computer generated street intersections with pedestrians, traffic and control signals are projected to a large screen for the participant to view, like a movie. Twenty LV persons are recruited from a university LV rehabilitation facility. They are randomly assigned to practicing the selected visual skills at real or virtual street intersections. Their skill levels are evaluated at real intersections before and immediately after their scheduled training. The primary outcome of interest is the mean change of visual skills between pre- and post-training evaluations in the two groups. The training is not a rehabilitation intervention because only the changes in visual/audio information gathering skills are trained and observed. The participants are trained and evaluated on the sidewalks of the real and virtual street. They are never allowed to step down the curb to avoid exposure to any danger. The long-term goal is to develop interactive VR training systems that have multiple sensory and motor input and output modules and that incorporate the collective experiences of the LV rehabilitation profession. Adding such systems to LV curriculum can greatly improve the affordability, accessibility, efficiency and the scope of LV rehabilitation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low vision (virtual street training) | – | –Low vision subjects trained in virtual streets and observed in real streets |
| Low vision (real street training) | – | –Low vision subjects trained in real streets and observed in real streets |
Who may qualify
- Ages
- 19 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Low vision participants will be recruited from the patient populations of the Clinics of UAB School of Optometry and UAB Center for Low Vision Rehabilitation
Key inclusion criteria (3 listed)
- Ambulatory and have independent traveling as one of their rehabilitation goals.
- Participants with central field loss should have best corrected binocular visual acuity between 20/200 and 20/1000, but with relatively intact peripheral visual field (>80o).
- Participants with peripheral visual field loss should have >20/63 visual acuity and no more than 20 deg diameter but not less than 8 deg diameter visual field in the better eye.
Key exclusion criteria (9 listed)
- Participants who have a mixture of central and peripheral field loss.
- Previous or current recipient of O\&M training.
- Participants who have plans to receive O\&M training during the study period.
- Age younger than 19 or older than 81.
- Significant cognitive impairment as determined with the Short Portable Mental Status Questionnaire (≥2 errors); inability to understand and speak English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The percentage of dangerous street crossing decisions and the street crossing decision safety scores
Time frame: 3-5 1-hour visits
The percentage of dangerous street crossing decisions is determined at real street corners during pre- and post-training evaluation sessions. The subject is asked to say "GO" when she feels it is the safest time to cross the street. A crossing decision is scored as dangerous if it is initiated in the red traffic light cycle or if there is < 25% of the "WALK" cycle left. The percentage is the total number of dangerous decisions divided by the total number of crossing decisions made during one evaluation session. The safety of a crossing decision is further quantified by recording the decision timing using a stopwatch and by converting the recorded time to a safety score. The safety score is a continuous scale between 0 and 1.0. The larger the safety score, the safer is the crossing decision. A statistically significant reduction in the percentage dangerous crossing decisions and an increase in the safety scores after training is an indication of successful skill learning and transfer.
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 27 May 2015.
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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.
Lei Liu, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Vision, 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 3 inclusion and 9 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 27 May 2015. 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.
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?
The percentage of dangerous street crossing decisions and the street crossing decision safety scores (time frame: 3-5 1-hour visits). 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 27 May 2015.