NCT01691027

Brief Summary

The research is aimed at developing and testing a new method of visual-motor rehabilitation of Veterans with macular degeneration by using inexpensive "tablet" computers at home.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 24, 2012

Completed
9 months until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

February 23, 2018

Completed
Last Updated

February 23, 2018

Status Verified

August 1, 2017

Enrollment Period

2 years

First QC Date

September 19, 2012

Results QC Date

January 24, 2017

Last Update Submit

August 2, 2017

Conditions

Keywords

scotoma, centralvisual motor coordination

Outcome Measures

Primary Outcomes (1)

  • Improvement in Eye-hand Coordination

    Maze tracing represents the fine eye-hand coordination needed for a wide variety of manual tasks and an improvement in maze tracing indicates an improvement in eye-hand coordination

    base line, pre-test, post tracing and videogames training

Secondary Outcomes (1)

  • Stylus to Eclipse Area

    Base line, Pre and Post training (approximately 3 months)

Study Arms (1)

Visuo-motor training for low vision

EXPERIMENTAL

All participants undergo training on scotoma awareness, Line and Circle Tracing and Video games

Behavioral: Visuo-motor training

Interventions

Participants will undergo training on three developed software modules on Samsung Galaxy Note Pro tablets to see their effect on low vision rehabilitation

Also known as: Scotoma Awareness, Line and Circle Tracing, Video games (Pong and PacMan)
Visuo-motor training for low vision

Eligibility Criteria

Age55 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bilateral macular scotomas
  • Preferred Retinal Locus (PRL) in at least one eye
  • Visual acuity 20/400 or better in at least one eye
  • No peripheral visual field loss
  • No medications that could affect motor control
  • Normal arm/hand range of motion
  • Pass cognitive ability exam

You may not qualify if:

  • No macular scotomas
  • Visual acuity of 20/30 or better
  • Medications that affect motor control
  • Limited arm/hand range of motion
  • Fail cognitive ability exam

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kansas City VA Medical Center, Kansas City, MO

Kansas City, Missouri, 64128, United States

Location

MeSH Terms

Conditions

ScotomaBlindness, Cortical

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Health Scientist
Organization
Kansas City VA Medical center

Study Officials

  • George T Timberlake, PhD

    Kansas City VA Medical Center, Kansas City, MO

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All eligible subjects trained on three computer-based training modules. SLO assessment of changes in fine manual task performance and in retinal functional geography was done before and after each training module.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2012

First Posted

September 24, 2012

Study Start

July 1, 2013

Primary Completion

July 1, 2015

Study Completion

December 1, 2015

Last Updated

February 23, 2018

Results First Posted

February 23, 2018

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations