Low Vision Aid Device for Farsightedness

(Opti-K Pres Trial)

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the VIS Opti-K Low Vision Aid, designed to improve vision for people with farsightedness. It targets individuals who have difficulty seeing up close, such as when reading, and experience mild trouble seeing far away. Ideal participants do not wear contacts, have good overall eye health, and require glasses for reading. The trial aims to determine if this device can improve their sight without the need for glasses. As an unphased trial, it offers participants the chance to potentially enhance their vision with an innovative device.

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 prior data suggests that this device is safe for vision improvement?

Earlier studies have used the VIS Opti-K Low Vision Aid device to assist individuals with vision issues like presbyopia (difficulty seeing things up close with age) and hyperopia (farsightedness). These studies have evaluated the device's safety and effectiveness in improving vision.

The VIS Opti-K device is noninvasive, meaning it doesn't involve surgery, which typically results in fewer risks and side effects compared to surgical treatments. Initial results from other studies suggest that most people tolerate the device well. Some mild side effects have been reported, but they are uncommon.

This trial is in the "Not Applicable" phase, indicating that the device is still under study for wider use, though it has already passed some safety checks. Always discuss any concerns with a doctor before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The VIS Opti-K Low Vision Aid Device is unique because it offers a non-invasive solution for farsightedness, unlike traditional options like glasses or contact lenses. This device is designed to enhance vision through advanced optics, potentially providing a more seamless experience for users compared to conventional corrective lenses. Researchers are excited about this treatment because it could offer an immediate improvement in vision without the need for surgical intervention or ongoing maintenance associated with other vision correction methods.

What evidence suggests that the VIS Opti-K Low Vision Aid Device is effective for vision improvement in farsightedness?

Research shows that the VIS Opti-K Low Vision Aid device, used by participants in this trial, may improve vision for those who are farsighted or have difficulty seeing up close due to aging. Studies have found that the device can enhance clarity by temporarily adjusting eye focus. This occurs through optimal keratoplasty, a method that reshapes the cornea to improve vision. Early results indicate that many users notice clearer vision for nearby objects. Although further research is necessary, these initial findings offer promise for those seeking non-surgical vision improvement. ^{1 4 6 7 8}

Who Is on the Research Team?

Michael Berry, PhD

Principal Investigator

VIS, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

Group I: Vision improvement Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

VIS, Inc.

Lead Sponsor

Trials

4

Recruited

610+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06597292

NCT06597292 | The VIS Opti-K Low Vision Aid Device ... The VIS Opti-K Low Vision Aid device will be used to provide vision improvement to patients with refractive disorders (hyperopia and presbyopia). Official Title.

2. withpower.com withpower.com/trial/phase-presbyopia-8-2024-608bb

Low Vision Aid Device for Farsightedness (Opti-K Pres Trial) The VIS Opti-K Low Vision Aid device will be used to provide vision improvement to patients with refractive disorders (hyperopia and presbyopia). Show more.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06487897

Phase III Presbyopia Correction Using the VIS Opti-K™ ... The goal of this clinical trial is to evaluate the safety and efficacy of using the VIS Opti-K System to enable monovision by providing temporary ...

4. ctv.veeva.com ctv.veeva.com/study/phase-iii-presbyopia-correction-using-the-vis-opti-k-system

Phase III Presbyopia Correction Using the VIS Opti-K™ System The goal of this clinical trial is to evaluate the safety and efficacy of using the VIS Opti-K System to enable monovision by providing temporary improvement ...

5. medrxiv.org medrxiv.org/content/medrxiv/early/2025/08/21/2025.08.16.25333839.full.pdf

Overcoming Emmetropic Presbyopia by Optimal Keratoplasty PURPOSE: To evaluate the safety and efficacy of the VIS Optimal Keratoplasty (Opti-K) device. 29 and procedure for treating eyes with ...

6. viscorrect.com viscorrect.com/

VIS - Home of Opti-K™ Opti-K™ is a groundbreaking, noninvasive laser-based procedure designed to address vision issues caused by presbyopia, hyperopia, myopia, and age-related ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06702020

VIS Opti-K Vision Improvement for Presbyopes The VIS Opti-K device and procedure were used to provide vision improvement to patients with presbyopia. Detailed Description. The VIS Opti-K device was used ...

8. withpower.com withpower.com/trial/phase-3-presbyopia-6-2024-4deeb

Laser Keratoplasty for Presbyopia (Opti-K™ Trial) The goal of this clinical trial is to evaluate the safety and efficacy of using the VIS Opti-K System to enable monovision by providing temporary ...