Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Providing Access to the Visual Environment

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Vanderbilt University
Tennessee Department of Education
Information provided by (Responsible Party):
Lori Ann Kehler, Vanderbilt University Identifier:
First received: June 20, 2006
Last updated: November 10, 2014
Last verified: November 2014

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.

Vision Impairment

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Providing Access to the Visual Environment

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Success to utilize optical devices [ Time Frame: 3-4 months ] [ Designated as safety issue: No ]
    Training with external optical devices to improve visual outcome

Estimated Enrollment: 795
Study Start Date: July 2001
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Detailed 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...


Ages Eligible for Study:   3 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Children age 3 to 21 years of age, enrolled in a TN school, with visual impairment


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00341744

Contact: Lori Ann F Kehler, O.D. 615-936-2020 lori.ann.kehler@Vanderbilt.Edu
Contact: Sandy A Owings, COA, CCRP 615-936-3465

United States, Tennessee
Vanderbilt Eye Institute Recruiting
Nashville, Tennessee, United States, 37232-8808
Contact: Sandy A Owings, COA, CCRP    615-936-3465   
Contact: Lori Ann Kehler, O.D.    615-936-2020    lori.ann.kehler@Vanderbilt.Edu   
Principal Investigator: Lori Ann Kehler, O.D         
Sponsors and Collaborators
Vanderbilt University
Tennessee Department of Education
Principal Investigator: Lori Ann Kehler, O.D. Vanderbilt Eye Institute
  More Information

No publications provided

Responsible Party: Lori Ann Kehler, Associate Professor of Ophthalmology, Vanderbilt University Identifier: NCT00341744     History of Changes
Other Study ID Numbers: 7633
Study First Received: June 20, 2006
Last Updated: November 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
Aids processed this record on February 27, 2015