Usefulness and performance with the IrisVision head-mounted video low vision aid in young individuals with congenital or early onset visual impairment

Primary Objective

The purpose of the study is to determine how useful the IrisVision low vision aid is to teenagers and young adults with congenital or early onset vision loss and how well subjects perform specific activities with the IrisVision.

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Description

The IrisVision is a headset that is used by individuals with impaired vision to help them see better. This study plans to learn more about how well the IrisVision works for the younger population. If you meet the following criteria, you may be screened to participate in this study: ? Age: 15-30 years. ? You have a congenital or early onset condition that resulted in loss of visual acuity. ? Your binocular visual acuity is 20/60 to 20/600.

Main Procedures Involved: The following will be done during each visit: ? First visit- (Dispense): o You will be given two short questionnaires, one that assesses how your vision impacts your daily life and another that assesses whether you are prone to motion sickness. We ask no one be in the room while you complete these questionnaires including parents, family members or friends. o Your distance visual acuity will be tested (reading letters on a chart) with your glasses and with the IrisVision. o Your contrast sensitivity will be tested (reading letters on a chart where the letters continually become more faded) with your glasses and with the IrisVision. Contrast sensitivity is the ability to distinguish an object from its background. o You will be taught how to use the IrisVision and it will be dispensed to you. ? Second Visit- Follow up #1 (1 month after Dispense): o Your distance visual acuity will be tested with your glasses and with the IrisVision. o Your reading speed will be tested twice- once with the Iris Vision and once with lenses determined by the examiner. o You will be given a similar questionnaire as in the first visit asking whether you experience motion sickness while wearing the IrisVision, we ask that no one be in the room with you while you complete this questionnaire including parents, family or friends. ? Third Visit- Follow up #2 (4 months after Dispense): o Your distance visual acuity will be tested with your glasses and with the IrisVision. Your distance visual acuity will be tested using 4Xbinoculars. o Your field of view will be tested using the IrisVision and with 4X binoculars. Field of view is the open observable area that you can see through your eyes when looking through a visual aid. ? Fourth Visit- Follow up #3 (9 months after Dispense): o Your distance visual acuity will be tested with your glasses and with the IrisVision. o Your reading speed will be tested twice- once with the IrisVision and once with lenses determined by the examiner. o You will be given 3 short questionnaires; one that assesses whether the IrisVision helped to improve your daily life, one that assesses whether you experience motion sickness while wearing the IrisVision, and the third one will ask some questions regarding the use of the IrisVision. We ask that no one be in the room with you while you complete these questionnaires including parents, family or friends. o Data will be gathered from IrisVision. o At the conclusion of the study, you will be offered to keep the IrisVision at no cost if you found it useful.

Duration of Participation: You will have 4 study visits that will last approximately 1-2 hours each. The entire study will last 9 months. At the first visit (dispense) we will give you the IrisVision, then you will return for a follow-up visit 1 month later, then 4 months after dispense and again at 9 months after dispense. You must also have had one initial low vision evaluation before enrolling in this study so that you can learn about all low vision device options available to you including the IrisVision. This evaluation is not part of the study.

Details
Age

15 to 30 years

Type of Study

Observational

Principal Investigator
Photograph of Melissa Engle,  OD

Melissa Engle, OD

Study ID

Protocol Number: 19-2383

Categories

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