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Vision, LowPhase 4NCT00366392

Project Magnify - A Comparison of Two Strategies to Improve Reading Ability

A Phase 4 study testing Optical Aids in people with Vision, Low, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 5 to 17 years
Conditions the study is for
Vision, Low
What is being tested?
Optical Aids
Type of treatment
Medical device
How many people
20 participants
Where
1 siteUnited States
Study dates
May 2005to Jul 2007
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • visually impaired with a permanent reduction of visual acuity in both eyes equal to or less than 20/70
  • enrolled in one of the South Carolina school districts served by the South Carolina School for the Deaf and Blind (SCSDB) outreach Teachers of the Visually Impaired (VI)
  • previously taught using large print materials without optical aids, or magnifiers
  • 5 to 17 years of age

Who cannot join

  • none

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Feldberg Center for Vision Rehabilitation, Medical University of South Carolina

    Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: Project Magnify - A Comparison of Two Strategies (Large Print Versus Optical Aids) for Helping Visually Impaired Students Improve Reading Abilities

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.

Read the detailed 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.

Conditions
Vision, Low
Being tested
Optical Aids
Keywords
Low Vision, Optical Aids
Medical subject headings
Vision, Low

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Optical AidsDevice

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2006 (estimated)
  2. Study startMay 2005
  3. Study completionJul 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00366392
Sponsor's protocol ID
SEI-05-001
Status last verified
Jul 2006
First submitted
17 Aug 2006
Last updated
3 Oct 2007
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Optical Aids in people with Vision, Low, run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2007.

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