50 Participants Needed

eSight Go for Low Vision Aids

(eSight Trial)

HG
Overseen ByHannah Grimes
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the eSight Go, a wearable device designed to assist people with vision impairments in improving daily activities. Participants will use the device at home and in everyday settings for four weeks to determine if it enhances their vision. The trial seeks individuals with stable vision issues, specifically those who struggle to see clearly even with prescription glasses. Participants should have a functional field of vision and benefit from magnification, and they should not have undergone recent eye surgeries or treatments.

As an unphased trial, this study provides participants the opportunity to contribute to innovative research and potentially improve their quality of life with enhanced vision.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, ongoing anti-VEGF treatments are allowed if you are in a specific management plan and your condition is stable.

What prior data suggests that the eSight Go device is safe for use in daily activities?

Research has shown that the eSight Go device is generally safe for users. eSight Go is a wearable device designed to assist people with vision problems. Studies have examined its effectiveness in improving vision, with safety as a key focus.

Past evaluations demonstrated that the device is safe for home use. Individuals as young as 13 years old can use it safely if they follow the instructions, though younger users might need supervision. The device has no known serious negative side effects and is intended for use in everyday settings like home, work, and stores.

In summary, eSight Go is well-tolerated by users and has no history of causing harm. Always follow the safety guidelines provided with the device.12345

Why are researchers excited about this trial?

The eSight Go is unique because it offers a wearable electronic solution for individuals with low vision, allowing them to utilize the device comfortably in familiar environments like home, work, or stores. Unlike traditional low vision aids such as magnifying glasses or screen readers, which can be cumbersome or limited in scope, eSight Go provides a hands-free, immersive experience that enhances visual information in real-time. Researchers are excited about this treatment because it empowers users to maintain independence and improve their quality of life by seamlessly integrating enhanced vision into daily activities.

What evidence suggests that the eSight Go device is effective for vision impairments?

Research has shown that eSight Go, a wearable device, greatly improves vision for people with central vision loss. One study demonstrated that users' ability to see things up close improved from 20/159 to 20/43, allowing for much clearer vision. Another study found that eSight Eyewear had impressive benefits on various aspects of vision. The FDA has registered this device, recognizing its effectiveness in helping people with low vision see better. Overall, evidence supports that eSight Go can significantly enhance daily life for those with vision impairments. Participants in this trial will use the eSight Go device at home for four weeks in environments where they feel comfortable, such as home, work, or stores.26789

Who Is on the Research Team?

KJ

Katelyn Jordan, D.O.

Principal Investigator

Brooks Rehabilitation

Are You a Good Fit for This Trial?

This trial is for individuals aged 18 to 90 with visual impairments (20/50 to 20/400 vision) stable for at least six months. Participants must show improvement with magnification, have a functional field of view, and pass a cognitive test. Exclusions include recent eye surgery or injections, severe visual impairment, cognitive issues, substance abuse history, or conflicts of interest.

Inclusion Criteria

Demonstrate visual benefit from magnification
I agree to wear the eSight Go device in different places.
Score ≥ 20 on the Short Orientation-Memory-Concentration Test of Cognitive Impairment (OMCT)
See 7 more

Exclusion Criteria

Self-report a history of alcoholism, drug abuse, or psychosis
My cognitive function is significantly impaired.
Exhibit clinical evidence of depression, poor motivation, emotional or intellectual problems, or any other conditions which would likely limit validity of consent or appropriate responses to participate in the study
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Introductory Training

Subjects receive introductory training on the controls of the study device at the initial study visit

1 day
1 visit (in-person)

At-Home Device Utilization

Participants use the eSight Go device at home for 4 weeks in various environments

4 weeks
Weekly follow-up phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • eSight Go
Trial Overview The study tests the eSight Go device by Gentex designed to enhance vision in daily activities for those with impaired sight. Participants will use this wearable tech at home and in various settings to assess its impact on their quality of life and ability to perform everyday tasks.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: At Home Device UtilizationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brooks Rehabilitation

Lead Sponsor

Trials
16
Recruited
1,900+

Citations

The Effect of a Head-mounted Low Vision Device on Visual ...The presented data indicate that the use of eSight Eyewear has striking beneficial effects on a variety of visual functions. Furthermore, 3 months of continued ...
eSight Electronic Eyewear for the Visually ImpairedNear distance visual acuity rose by five lines at device fitting, with mean acuity improving from 20/159 to 20/43. The investigators observed similar ...
ESIGHT QUALITY OF LIFE AND EFFICACY STUDYOver 100 million people in the developed world have low vision, defined by the World Health. Organization as best corrected visual acuity in the better eye of ...
Vision Professionals | eSight EyeweareSight is a proven digital device for patients with central vision loss. eSight is a clinically validated, FDA- and EUDAMED-registered ...
eSight showcases wearable assistive device for central ...eSight is a wearable assistive technology registered with the FDA that enables visually-impaired individuals to see with enhanced clarity while ...
Safety and CareInform the security officer that you have low vision and may require assistance with the screening process. If you travel with supporting documentation ...
Assessing the Impact of eSight Go At-Home Usage in ...Clinical trial for Low Vision Aids , Assessing the Impact of eSight Go At-Home Usage in Individuals With Visual Impairment.
8.esighteyewear.comesighteyewear.com/faq/
FAQ | eSight EyeweareSight Go is designed for users 13 years and up, ensuring they can safely understand and apply the safety instructions. Supervision for younger users is ...
9.esighteyewear.comesighteyewear.com/esight-go/
eSight Go | eSight EyeweareSight Go digital low-vision device helps people with significant central vision loss see more clearly and maintain their mobility and independence.
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