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.
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
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.
- First posted21 Aug 2006 (estimated)
- Study startMay 2005
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vision, LowStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- South Carolina School for the Deaf and the Blind
- Investigators
- Stephen Morse, MD, Principal investigator, Medical University of South Carolina
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Magnify - A Comparison of Two Strategies (Large Print Versus Optical Aids) for Helping Visually Impaired Students Improve Reading Abilities
- ClinicalTrials.gov ID
- NCT00366392
- Acronym / sponsor ID
- SEI-05-001
- Conditions
- Vision, Low
- Keywords
- Low Vision, Optical Aids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- South Carolina School for the Deaf and the Blind
- Study start
- May 2005
- Study completion
- Jul 2007 (actual)
- First posted
- 21 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical Aids | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Morse, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
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.