Trial Outcomes & Findings for Visuomotor Rehabilitation Training for Manual Task Deficits From Macular Scotomas (NCT NCT01691027)

Last Updated: 2018-02-23

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

4 participants

Primary outcome timeframe

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

Results posted on

2018-02-23

Participant Flow

Subjects with bilateral AMD, no foveal vision, and acuities poorer than 20/60 in each eye were screened in the eye clinic and those who met inclusion criteria were enrolled in the study. On each laboratory visit, subjects' eyes were checked for angle closure and, if angles wee open, dilated the eye to be tested

Enrolled subjects when found to have residual foveal vision in baseline SLO retinal functional map and/or are unable to follow the instructions for SLO testing were excluded from the study before training assignment.

Participant milestones

Participant milestones
Measure	Visuo-motor Training for Low Vision All participants undergo training on scotoma awareness, Line and Circle Tracing and Video games
Scotoma Awareness STARTED	4
Scotoma Awareness COMPLETED	4
Scotoma Awareness NOT COMPLETED	0
Line and Circle Tracing Training STARTED	4
Line and Circle Tracing Training COMPLETED	4
Line and Circle Tracing Training NOT COMPLETED	0
Video Games Training STARTED	4
Video Games Training COMPLETED	4
Video Games Training NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Only 4 subjects with ages in range of 65 to 92 participated and were able to complete all training.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Crossover Design. All Subjects Undergo All Treatments. n=4 Participants Each participating subject will have three training modules on a tablet computer: scotoma awareness, line and curve tracing, and video games. The order of modules will be different for different groups of subjects. Training on a module will cease when the subject reaches a performance criterion. Retinal assessments will occur after each training module completion.
Age, Continuous	84.5 Years n=5 Participants • Only 4 subjects with ages in range of 65 to 92 participated and were able to complete all training.
Sex: Female, Male Female	1 Participants n=5 Participants • Four subjects 1 female and 3 males participated and completed all testing
Sex: Female, Male Male	3 Participants n=5 Participants • Four subjects 1 female and 3 males participated and completed all testing
SLO retinal functional map	80 percent traced n=5 Participants

PRIMARY outcome

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

Population: Out of Ten selected subjects, 3 were rejected after completing Baseline SLO retinal function map because of residual foveal vision. Two subjects failed to follow the instructions for SLO testing. One subject completed initial phase but failed to complete testing because of medical problems. Four subjects were able to complete all testing.

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

Outcome measures

Outcome measures
Measure	Visuo-motor Training n=4 Participants Participants undergo training on three modules, (1)scotoma awareness, (2) line and curve tracing, and (3) video games. SLO assessments of changes in fine manual task performance was measured by an improvement in mean maze tracing and printing score. Improvement in visuo-motor control was measured by stylus ellipse area and stylus-PRL distance before and after training.
Improvement in Eye-hand Coordination Participant 1 baseline	42.8 Percentage
Improvement in Eye-hand Coordination Participant 1 pretest	45.4 Percentage
Improvement in Eye-hand Coordination Participant 1 post tracing	30.4 Percentage
Improvement in Eye-hand Coordination Participant 1 post gaming	71.0 Percentage
Improvement in Eye-hand Coordination Participant 2 baseline	76.8 Percentage
Improvement in Eye-hand Coordination Participant 2 pretest	54.8 Percentage
Improvement in Eye-hand Coordination participant 2 post tracing	51.0 Percentage
Improvement in Eye-hand Coordination Participant 2 post games	94.3 Percentage
Improvement in Eye-hand Coordination Participant 3 baseline	68.7 Percentage
Improvement in Eye-hand Coordination Participant 3 pre test	79.9 Percentage
Improvement in Eye-hand Coordination Participant 3 post tracing	95.5 Percentage
Improvement in Eye-hand Coordination Participating 3 post games	95.1 Percentage
Improvement in Eye-hand Coordination Participant 4 baseline	44 Percentage
Improvement in Eye-hand Coordination Participant 4 pre test	30.5 Percentage
Improvement in Eye-hand Coordination Participant 4 post tracing	65.8 Percentage
Improvement in Eye-hand Coordination Participant 4 post games	62.3 Percentage

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Visuo-motor Training n=4 Participants Participants undergo training on three modules, (1)scotoma awareness, (2) line and curve tracing, and (3) video games. SLO assessments of changes in fine manual task performance was measured by an improvement in mean maze tracing and printing score. Improvement in visuo-motor control was measured by stylus ellipse area and stylus-PRL distance before and after training.
Stylus to Eclipse Area Participant 1 baseline	45.2 Degree
Stylus to Eclipse Area Participant 1 pre test	77.6 Degree
Stylus to Eclipse Area Participant 1 post tracing	39.4 Degree
Stylus to Eclipse Area Participant 1 post games	40.8 Degree
Stylus to Eclipse Area Participant 2 base line	26.8 Degree
Stylus to Eclipse Area Participant 2 pre test	22.6 Degree
Stylus to Eclipse Area Participant 2 post tracing	20.9 Degree
Stylus to Eclipse Area Participant 2 post games	11.1 Degree
Stylus to Eclipse Area Participant 3 base line	25 Degree
Stylus to Eclipse Area Participant 3 pre test	21.8 Degree
Stylus to Eclipse Area Participant 3 post tracing	47.4 Degree
Stylus to Eclipse Area Participating 3 post games	47.1 Degree
Stylus to Eclipse Area Participnat 4 base line	28.4 Degree
Stylus to Eclipse Area Participant 4 pre test	14.6 Degree
Stylus to Eclipse Area Participant 4 post tracing	17.8 Degree
Stylus to Eclipse Area Participant 4 post games	11.8 Degree

Adverse Events

Subjects With Bilateral AMD, no Foveal Vision and 20/60 Vision

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Health Scientist

Kansas City VA Medical center

Phone: 816-861-4700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place