NCT02310880

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

May 27, 2015

Status Verified

December 1, 2014

Enrollment Period

4.5 years

First QC Date

December 3, 2014

Last Update Submit

May 25, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    3-5 1-hour visits

Study Arms (2)

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

Eligibility Criteria

Age19 Years - 81 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Clinical Eye Research Facility

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Vision, Low

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lei Liu, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2014

First Posted

December 8, 2014

Study Start

September 1, 2010

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

May 27, 2015

Record last verified: 2014-12

Locations