Not Yet RecruitingNot Applicable

The VIS Opti-K Low Vision Aid Device Provides Vision Improvement.

United States, Canada200 participantsStarted 2024-09-16

Plain-language summary

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

Age range40 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or Female
✓. Any race
✓. Patient is at least 40 years old.
✓. Patient is pseudophakic or is phakic with no clinically significant cataract in eye(s) to be treated.
✓. Patient has manifest refraction, spherical equivalent (MRSE) between -0.50 D to 2.50 D, with no more than 1.0 D of refractive cylinder, in eye(s) to be treated.
✓. 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.
✓. Patient has uncorrected near visual acuity (UNVA) between 20/50 (LogMAR 0.40) and better than 20/100 (LogMAR \< 0.70) in eye(s) to be treated.

Uncorrected Distance Visual Acuity (UDVA)

Timeframe: Up to 24 months post-treatment

Uncorrected Near Visual Acuity (UNVA)

Timeframe: Up to 24 months post-treatment

NCT IDNCT06597292

SponsorVIS, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09-30

Michael Berry, PhD