Low Vision Aid System for Age-Related Macular Degeneration

(AMD Trial)

Overseen By Samuel N Markowitz, MD, FRCSC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Optimal Acuity Corporation

Disqualifiers: Corneal disease, Glaucoma, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Optimal Acuity Clear-K® Low Vision Aid System to determine if it can safely and effectively improve vision for people with age-related macular degeneration (AMD), which causes blurry or reduced vision. It targets patients diagnosed with either dry or inactive wet AMD in one or both eyes. Participants should have moderate to severe vision impairment and not wear contact lenses. Those who struggle with clear vision due to AMD and do not have other eye conditions like cataracts might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative solutions for vision improvement in AMD patients.

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

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 the Optimal Acuity Clear-K® Low Vision Aid System is safe for patients with age-related macular degeneration?

Research shows that the Optimal Acuity Clear-K® Low Vision Aid System is being tested for safety and effectiveness in people with age-related macular degeneration. Earlier studies suggest that similar treatments, such as corneal laser procedures, are generally safe. These treatments can enhance vision by making small changes to the cornea (the clear front part of the eye) and redirecting light to healthier parts of the retina (the light-sensitive layer at the back of the eye). Although data is limited, these treatments are usually well-tolerated, with few serious side effects reported. This suggests that the Clear-K system may also be safe, but ongoing studies are needed to confirm this. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for age-related macular degeneration (AMD), which typically involve medications like anti-VEGF injections to slow vision loss, the Optimal Acuity Clear-K® Low Vision Aid System offers a new approach by enhancing residual vision. This system is unique because it uses advanced optics and digital processing to improve visual clarity and contrast for people with AMD. Researchers are excited about this treatment because it could significantly improve the quality of life for patients by making everyday activities easier, offering a non-invasive alternative to traditional therapies.

What evidence suggests that the Optimal Acuity Clear-K® Low Vision Aid System is effective for age-related macular degeneration?

Research has shown that the Optimal Acuity Clear-K® Low Vision Aid System might help people with age-related macular degeneration see better. This system reshapes the cornea slightly to direct light onto functioning parts of the retina, potentially improving vision. Early results suggest that users of this system have experienced clearer vision. However, researchers are still collecting more detailed study results to confirm its effectiveness. ^{1 2 3 4 6}

Who Is on the Research Team?

Michael Berry, PhD

Principal Investigator

Optimal Acuity Corporation

Are You a Good Fit for This Trial?

This trial is for people over 50 with age-related macular degeneration (AMD) in one or both eyes, confirmed by a retina specialist. Participants must have moderate to severe vision impairment due to AMD but no significant cataracts or corneal diseases. They should not wear contact lenses and must be able to give informed consent.

Inclusion Criteria

I am 50 years old or older.

You do not wear contact lenses.

I am either male or female.

Exclusion Criteria

I have high eye pressure or a history of glaucoma.

Corneal topographic astigmatism greater than 2.00 D (mean value within 3.0 mm optical zone)

Potential Visual Acuity (PVA) in both eyes that is not improved by at least three lines compared to CDVA

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients are treated by the Optimal Acuity Clear-K Low Vision Aid System

Immediate

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Optimal Acuity Clear-K® Low Vision Aid System

Trial Overview The study tests the Optimal Acuity Clear-K® Low Vision Aid System's effectiveness and safety in improving vision for those with AMD. It aims to see if this treatment can help patients see better.

How Is the Trial Designed?

Group I: Treatment arm Experimental Treatment 1 Intervention

Patients will be treated by the Optimal Acuity Clear-K Low Vision Aid System.

Who Is Running the Clinical Trial?

Optimal Acuity Corporation

Lead Sponsor

Trials

4

Recruited

310+

Bochner Eye Institute

Collaborator

Bochner Eye Institute

Collaborator

Trials

2

Recruited

220+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04268836

Vision Improvement for Patients With Age-Related Macular ... The purpose of this study is to determine whether the Optimal Acuity Clear-K® Low Vision Aid System provides a safe and effective treatment to improve vision ...

2. ctv.veeva.com ctv.veeva.com/study/vision-improvement-for-patients-with-age-related-macular-degeneration

Vision Improvement for Patients With Age-Related Macular ... The purpose of this study is to determine whether the Optimal Acuity Clear-K® Low Vision Aid System provides a safe and effective treatment ...

3. withpower.com withpower.com/trial/phase-macular-degeneration-9-2021-719b3

Low Vision Aid System for Age-Related Macular ... The purpose of this study is to determine whether the Optimal Acuity Clear-K® Low Vision Aid System provides a safe and effective treatment to improve ...

4. bochner.com bochner.com/wp-content/uploads/2023/08/CPV-AMD_ArticleDec2020.pdf

Corneal laser procedure for vision improvement in patients Treatments were completed using a Clear-K® Low Vision Aid. System ... measure optimal visual acuity in age-related macular degeneration.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04875234

Vision Improvement for Legally Blind Dry AMD Patients A Clear-K Low Vision Aid Device is used to produce small corneal shape and refraction changes in order to redirect light onto functional areas of the retina.

6. datadryad.org datadryad.org/dataset/doi:10.5061/dryad.m905qfv2r

Corneal Laser Procedure for safety and efficacy in vision ... Conclusions: Subject to a small sample size, the CPV corneal laser procedure is safe and efficacious for vision improvement in patients with ...