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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00341744
Other study ID # 7633
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 2001
Est. completion date December 2028

Study information

Verified date June 2023
Source Vanderbilt University Medical Center
Contact Lori Ann F Kehler, O.D.
Phone 615-936-2020
Email lori.ann.kehler@Vanderbilt.Edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Providing Access to the Visual Environment is a pediatric low vision grant which has the ability to provide comprehensive, interdisciplinary low vision rehabilitation services to every child in Tennessee with a vision impairment. Children, ages 3-21, with best-corrected vision of 20/50 or worse in the better seeing eye are prescribed optical devices to improve their visual functioning and trained to use the devices.


Description:

Subjects are enrolled each school year based on referrals from school systems in Tennessee, ophthalmologists, and optometrists. A total of 90 new students are enrolled each year. Students are provided a comprehensive low vision rehabilitation evaluation by a low vision optometrist and prescribed optical devices to improve distance appreciation, near reading, and other tasks based on individual needs. Students are then trained to use the devices efficiently by master's level teachers of the visually impaired. The teachers travel to the students environment (school/home/work) for the training. Variables such as ocular disease, age, visual acuity, visual improvement with optical devices, type of optical device, and reading speed are defined for each student. Providing Access to the Visual Environment also provides...


Recruitment information / eligibility

Status Recruiting
Enrollment 795
Est. completion date December 2028
Est. primary completion date December 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 21 Years
Eligibility Inclusion Criteria: Children age 3 to 21 years of age Enrollment in a school in Tennessee (private or public) - Children that are eligible for services due to visual impairment Low vision Exclusion Criteria: - Children who do not have the potential to become readers or use their vision for reading

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Saige Wilkins Nashville Tennessee

Sponsors (2)

Lead Sponsor Collaborator
Vanderbilt University Tennessee Department of Education

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Success to utilize optical devices Training with external optical devices to improve visual outcome 3-4 months
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