Low Vision Aid Device for Farsightedness

(Opti-K Pres Trial)

Recruiting at 1 trial location

Overseen By Harry Glen, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VIS, Inc.

Disqualifiers: Corneal disease, Glaucoma, Diabetes, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4-8 weeks

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinator or your doctor.

What data supports the effectiveness of the VIS Opti-K Low Vision Aid Device treatment for farsightedness?

Research shows that optical visual aids can significantly improve vision in patients with low vision conditions, such as age-related macular degeneration, with most patients experiencing better distance and near vision. This suggests that similar devices, like the VIS Opti-K Low Vision Aid Device, could be effective for improving vision in people with farsightedness. ^{1 2 3 4 5}

Is the Low Vision Aid Device for Farsightedness generally safe for humans?

There is no specific safety data available for the Low Vision Aid Device for Farsightedness, but a study on pharmaceutical agents used in optometry showed a low incidence of adverse reactions, suggesting that similar devices might also be generally safe. ^{6 7 8 9 10}

How does the VIS Opti-K Low Vision Aid Device differ from other treatments for farsightedness?

The VIS Opti-K Low Vision Aid Device is unique because it is a wearable device that combines optical and digital technology to provide both near and far field magnification, unlike traditional aids that typically focus on one or the other. It offers a high level of magnification and a long battery life, making it versatile and convenient for users with low vision. ^{1 11 12 13 14}

What is the purpose of this trial?

The VIS Opti-K Low Vision Aid device will be used to provide vision improvement to patients with refractive disorders (hyperopia and presbyopia).

Research Team

Michael Berry, PhD

Principal Investigator

VIS, Inc.

Eligibility Criteria

This trial is for adults over 40 with presbyopia or farsightedness, who have a certain level of uncorrected and corrected visual acuity, need reading glasses of +1.0 to +3.0 D, and have normal corneal topography without significant cataracts. It's not for those with diabetes, glaucoma, high eye pressure, pregnancy, nystagmus (rapid eye movement), any corneal disease or past eye surgeries.

Inclusion Criteria

Patient has uncorrected distance visual acuity (UDVA) of 20/100 or better (i.e., LogMAR ≤ 0.70) in both eyes

Patient has best corrected distance visual acuity (CDVA) of 20/20 or better (i.e., LogMAR ≤ 0.00) in both eyes

I am either male or female.

Exclusion Criteria

I have diabetes.

I have high eye pressure or a history of glaucoma.

Pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the VIS Opti-K Low Vision Aid device for vision improvement

4-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Treatment Details

Interventions

• VIS Opti-K Low Vision Aid Device

Trial Overview The VIS Opti-K Low Vision Aid device is being tested to see if it can improve vision in people with refractive disorders like hyperopia (farsightedness) and presbyopia (age-related difficulty focusing on close objects).

Participant Groups

Group I: Vision improvement Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

VIS, Inc.

Lead Sponsor

Trials

4

Recruited

610+

Findings from Research

In a national study conducted over two years, only 36 cases of visual impairment due to adverse drug reactions (ADRs) were reported, with 23 cases resulting in permanent visual impairment, indicating that such occurrences are rare but significant.

Most visual impairments were linked to known medications with side effects, highlighting the need for careful monitoring of ocular ADRs, especially in populations like the elderly who may be taking multiple medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active surveillance of visual impairment due to adverse drug reactions: findings from a national study in the United Kingdom. Cumberland, PM., Russell-Eggitt, I., Rahi, JS.[2022]

References

1. Czech Republic pubmed.ncbi.nlm.nih.gov

[Prescription of special optical aids for visual defects. II]. [2008]

2. China pubmed.ncbi.nlm.nih.gov

Visual rehabilitation in low vision patients with age-related macular degeneration. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Visual rehabilitation in low vision patients with aging macular degeneration. [2004]

4. China pubmed.ncbi.nlm.nih.gov

[Use of visual aids for vision of disabled children]. [2006]

5. China pubmed.ncbi.nlm.nih.gov

[Visual rehabilitation in low vision patients with aging macular degeneration]. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Use of diagnostic pharmaceutical agents and incidence of adverse effects. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Five-year results of atropine 0.01% efficacy in the myopia control in a European population. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

IMI 2021 Reports and Digest - Reflections on the Implications for Clinical Practice. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Active surveillance of visual impairment due to adverse drug reactions: findings from a national study in the United Kingdom. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Food and Drug Administration, American Academy of Ophthalmology, American Academy of Optometry, American Association for Pediatric Ophthalmology and Strabismus, American Optometric Association, American Society of Cataract and Refractive Surgery, and Contact Lens Association of Ophthalmologists Co-Sponsored Workshop: Controlling the Progression of Myopia: Contact Lenses and Future Medical Devices. [2018]

11. Germany pubmed.ncbi.nlm.nih.gov

[A reading aid for the visually handicapped]. [2009]

12. Germany pubmed.ncbi.nlm.nih.gov

[Use of a new optoelectronic vision aid for highly visually handicapped patients]. [2009]

13. Germany pubmed.ncbi.nlm.nih.gov

[Low Vision Enhancement System (LVES). Initial clinical experiences with a new kind of optoelectronic rehabilitation system]. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Wearable optical-digital assistive device for low vision students. [2020]