Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00366392 |
| Other study ID # |
SEI-05-001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
August 17, 2006 |
| Last updated |
October 2, 2007 |
| Start date |
May 2005 |
| Est. completion date |
July 2007 |
Study information
| Verified date |
July 2006 |
| Source |
Medical University of South Carolina |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Institutional Review Board |
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of Project Magnify is to determine which of the two current strategies (large
print versus optical aids) for helping visually impaired students improve their reading
abilities works better. Our hypothesis is that optical aids work better than providing the
student with large print materials. Since large print materials are of one size only, and
the level of visual impairments among students varies greatly, it seems apparent that large
print materials will work well for some students, but not for all. An optical aid designed
for each individual student's level of impairment seems to hold more promise in helping each
student reach their maximum level of performance. Although Project Magnify is designed to
increase reading abilities, it is expected that students will also develop greater
independence and confidence in home and community activities that require the use of vision.
Description:
The purpose of Project Magnify is to determine which of the two current strategies (large
print versus optical aids) for helping visually impaired students improve their reading
abilities works better. Our hypothesis is that optical aids work better than providing the
student with large print materials. Since large print materials are of one size only, and
the level of visual impairments among students varies greatly, it seems apparent that large
print materials will work well for some students, but not for all. An optical aid designed
for each individual student's level of impairment seems to hold more promise in helping each
student reach their maximum level of performance. Although Project Magnify is designed to
increase reading abilities, it is expected that students will also develop greater
independence and confidence in home and community activities that require the use of vision.
Students with low vision are frequently given large print books to read. Large print does
give many students the opportunity to access information in textbooks. However, there are
several limitations to this strategy. First, the student only has access to the print that
has been enlarged for him. And large print material is of only one size, while student's
level of vision impairment varies greatly. So the large print may be fine for one visually
impaired student, but significantly too small for another, and way too big for yet a third.
When large print is a child's only option for accessing print, he struggles to copy notes
off the board, find the right bus in the bus line and correctly measure the chemicals in the
science laboratory experiment. Additionally, the difficulties and costs related to enlarging
colored pictures, graphs and charts result in second rate productions of graphics; thereby,
hindering comprehension of critical information. Furthermore, the cost of large print books
is exorbitant. According to Jill Ischinger the Director of the South Carolina Instructional
Resource Center (personal communication), IRC, the cost of providing a set of books to
students each year is approximately $2,237. Finally, students who choose to further their
education beyond high school are severely limited with reading options. Unlike primary and
secondary school where the Department of Education purchased the textbooks and the books
were generally available in large print, college students frequently lack the resources to
pay for the costly, rare books.
Moreover, previous studies have found that the reading rates of large print readers are not
commensurate with their regular print readers. With the current pressure of high stakes
testing and greater achievement, readers with visual impairments are at an increased risk of
falling further behind in school.
Project Magnify is modeled after a successful study sponsored by Vanderbilt University in
Tennessee: Providing Access to the Visual Environment (PAVE). PAVE provides comprehensive
low vision services to school aged children throughout the state of Tennessee. The services
provided by PAVE include clinical low vision evaluations and instruction in the use of the
low vision aids. When PAVE was initiated, Corn, Wall and Bell researched the reading rates
of students with low vision reading with optical aids to the reading rates of non-visually
impaired students. The study showed that while students with visual impairments continue to
lag behind their peers in reading rates optical aids significantly reduce the disparity
(1999). Our study is designed to replicate a portion of this pioneer study and expand upon
it by comparing the two dominant methods of helping visually impaired students improve their
reading skills: large print versus optical aids.
Whereas PAVE compared the reading rates of optical aid users to their sighted peers, Project
Magnify seeks to determine the benefits of optical aids as compared to large print. In our
study design, the students using large print alone will be the control group. Students in
the experimental group will use an optical aid prescribed specifically for their use. The
main outcome measures are the reading tests that are conducted before and after the twelve
month reading treatments. The differences in the before and after reading rates are compared
to determine statistical significance. Since the reading rates are on a normal numerical
scale, parametric statistics can be used to compare the different reading rates. A Students
T-test will allow us to compare the differences in reading rates for the two groups of
visually impaired students. To conduct this study, twenty students currently served by the
South Carolina School for the Deaf and the Blind Division of Outreach Services (SCSDB) will
be referred for inclusion in the study. The reading levels of all of the students will be
assessed with a formal reading assessment. Students will then be randomly assigned to two
groups. The large print readers in the control group will receive instruction as currently
indicated on their Individual Education Plans (IEPs). Students in the second group will
travel to the Feldberg Center in Charleston for a clinical low vision evaluation.
Furthermore, these students will receive monthly instruction in the use of the low vision
aids throughout the duration of the study. At the study's close, reading levels of the
students in both groups will be assessed. The change in reading rates of the students will
be compared to determine whether a significance difference exists between optical aids and
large print.
