Central Visual Impairment Clinical Trial
Official title:
Visuomotor Rehabilitation Training for Manual Task Deficits From Macular Scotomas
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.
The research objective is to test the hypothesis that practicing eye-hand coordination using
tablet-computers can improve manual skills of those with Age-related Macular Degeneration
(AMD). AMD causes the loss of sharp central vision used for reading and many other everyday
activities. Those with AMD experience a "macular scotoma", a blanked-out area of whatever
they're attempting to look at, and they must use an area of peripheral vision, the "Preferred
Retinal Locus (PRL)" to look at objects of interest. The PRL does not provide sharp vision,
causing deficits in eye-hand coordination needed for manual tasks. There have been few
studies of visuo-motor rehabilitation training for deficits caused by macular scotomas.
However, a recent study demonstrated that visuo-motor eye movement training dramatically
improved reading ability of subjects with AMD. In addition, it has been shown that playing
action video games can improve certain visual skills. Thus, a small but growing body of
research suggests that it may be possible to ameliorate manual task deficits caused by AMD
through computer-based visuo-motor rehabilitation training.
To test this idea, two visuo-motor training modules will be developed for low-cost tablet
computers that subjects will use at home. Modules will be for, line and circle tracing, and
video games. Both modules will involve PRL-hand coordination by moving a stylus on the tablet
screen in response to stimuli. Line and circle tracing will develop eye-hand coordination
skills needed for printing. The video game module will provide practice in PRL-hand
coordination. Progress in PRL-hand coordination will be automatically recorded on the
tablet-computer.
Changes in manual task performance from the training modules will be assessed after each
training module using previously developed Scanning Laser Ophthalmoscope (SLO) tests of
maze-tracing, and printing. The SLO will also be used to determine the position and fixation
stability of the subject's PRL and the retinal position of the scotoma. SLO testing will be
repeated three months after all training. Digitized SLO video images showing the hand,
stylus, and object on the retina will be measured and analyzed. Several performance measures
will be derived from the SLO image analysis including maze-tracing accuracy, printing
legibility, retinal area of the stylus, percentage of time the stylus is in the scotoma, and
PRL retinal area. This data will be statistically analyzed to determine whether visuo-motor
training with the computer tablets improves manual task performance and whether one module is
more effective than other.
There will be six groups of five subjects. Subjects will be assigned as they are recruited to
a group until the group is full. Two groups will have training delayed by 6 months and will
be tested on the SLO 4 times to assess changes in the dependent measure without training.
Following training on each module, subject will be tested on maze tracing and printing in the
SLO. Two groups undergo four SLO tests without training and begin training six months later.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05439759 -
Factors in Learning And Plasticity: Healthy Vision
|
N/A | |
Recruiting |
NCT05454124 -
Factors in Learning And Plasticity: Macular Degeneration
|
N/A | |
Recruiting |
NCT05456581 -
Scotoma Perimetry Oculomotor Training
|
N/A | |
Enrolling by invitation |
NCT03640130 -
Peripheral Reading
|
N/A | |
Not yet recruiting |
NCT05637385 -
Training Oculo-motor Control to Improve Vision When Using a Preferred Retinal Locus
|
N/A |