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Clinical Trial Summary

This study aims to compare the efficacy of an in-home telehealth-based intervention to standard care for children with cortical visual impairment and their caregivers and to assess the feasibility and acceptability of an in-home telehealth-based intervention approach for children with cortical visual impairment and their caregivers. This pilot study will utilize a randomized two group crossover design with assessment at 4 time periods. The assessments will occur at remote locations.


Clinical Trial Description

To improve access to evaluation and treatment, the investigators will be offering remote cortical visual impairment clinics to assess children for cortical visual impairment. The cortical visual impairment clinics will be organized in public spaces such as school buildings, libraries, and/or hospital clinics. Study staff will contact potential clinics, buildings, etc., about interest in hosting these remote clinics. The cortical visual impairment clinics will be staffed by at least one of the following individuals: an ophthalmologist and/or an optometrist, a technician, and an occupational therapist. All participants will attend 4 remote cortical visual impairment clinics during the study. Prior to the initial clinic visit, the participants will be randomized into either the waitlist control group or the intervention group using the list of patients scheduled for the clinic. During the initial clinic visit, each child who has been given parental consent will complete both an eye exam (either an ophthalmologist or an optometrist) and functional vision evaluation with an occupational therapist. Both the eye exam and the functional vision evaluation occurring during the clinic visit are the same as would be provided during routine clinical care. None of the examinations provided during this research study will be billed through insurance. Those who are diagnosed with cortical visual impairment will continue on with the study. The intervention group will complete the telehealth intervention sessions and the waitlist control group will continue with standard care. All participants will attend three additional cortical visual impairment Clinics: one 4 months after the initial evaluation (+/- 2 weeks), one 8 months after initial evaluation (+/- 2 weeks) and another 12 months after the initial evaluation (+/- 2 weeks). During the final three cortical visual impairment clinics, the participants will complete and updated Cortical Visual Impairment Range and Canadian Occupational Performance Measure with the occupational therapist. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03957980
Study type Interventional
Source Children's Hospital Medical Center, Cincinnati
Contact
Status Completed
Phase N/A
Start date May 2, 2017
Completion date November 13, 2018

See also
  Status Clinical Trial Phase
Completed NCT00342108 - Cortical Visual Impairment and Visual Attentiveness N/A