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Low Vision Aid Device

Low Vision Aid Device for Farsightedness (Opti-K Pres Trial)

N/A
Waitlist Available
Research Sponsored by VIS, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is at least 40 years old
Patient is pseudophakic or is phakic with no clinically significant cataract in eye(s) to be treated
Must not have
Corneal disease or corneal disorder in either eye
Increased IOP (above 20 mm Hg), glaucoma or history of glaucoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months post-treatment
Awards & highlights
No Placebo-Only Group

Summary

"This trial will use the VIS Opti-K Low Vision Aid device to help improve vision for patients with refractive disorders like hyperopia and presbyopia."

Who is the study for?
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.
What is being tested?
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).
What are the potential side effects?
Potential side effects are not specified but may include discomfort while using the device or temporary visual disturbances after use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am at least 40 years old.
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I have had cataract surgery or don't have significant cataracts in the eye(s) to be treated.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a corneal disease or disorder in one or both eyes.
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I have high eye pressure or a history of glaucoma.
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I have an active eye surface condition.
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I have had corneal surgery in the eye that needs treatment.
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I experience involuntary eye movements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Uncorrected Distance Visual Acuity (UDVA)
Uncorrected Near Visual Acuity (UNVA)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Vision improvementExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

VIS, Inc.Lead Sponsor
2 Previous Clinical Trials
275 Total Patients Enrolled
Michael Berry, PhDStudy DirectorVIS, Inc.
3 Previous Clinical Trials
257 Total Patients Enrolled
~133 spots leftby Sep 2026
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