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

Launched by VIS, INC. · Sep 11, 2024

Keywords

ClinConnect Summary

The VIS Opti-K Low Vision Aid Device study is researching a new device designed to help people with vision problems, specifically those who have difficulty seeing far away (hyperopia) or have trouble focusing on close objects as they age (presbyopia). The goal is to see if this device can improve vision for patients who meet certain criteria, such as being at least 40 years old and having specific levels of vision quality.

To be eligible for the study, participants should not wear contact lenses and must have clear corneas, along with certain visual acuity requirements. For example, they should be able to see at least 20/100 without correction and have better vision when using corrective lenses. Participants can expect to undergo various examinations to assess their vision and must be willing to follow study instructions. It’s important to know that individuals with certain eye conditions, like glaucoma or previous eye surgeries, cannot participate. This study is not yet recruiting, so there’s still time to learn more before enrollment begins.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Subjects who meet all of the following criteria are candidates for this study:
• • 1. Male or Female
• • 2. Any race
• • 3. Patient is at least 40 years old.
• • 4. Patient is pseudophakic or is phakic with no clinically significant cataract in eye(s) to be treated.
• • 5. 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.
• • 6. Patient has uncorrected distance visual acuity (UDVA) of 20/100 or better (i.e., LogMAR ≤ 0.70) in both eyes.
• • 7. Patient has best corrected distance visual acuity (CDVA) of 20/20 or better (i.e., LogMAR ≤ 0.00) in both eyes.
• • 8. 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.
• • 9. Patient has best corrected near visual acuity (CNVA) of at least 20/20 (LogMAR ≤ 0.00) in eye(s) to be treated.
• • 10. Patient requires reading adds of +1.0 to +3.0 D in eye(s) to be treated.
• • 11. Patient is not a contact lens (CL) wearer.
• • 12. Patient has normal corneal topography.
• • 13. Patient is willing and able to comply with all examinations.
• • 14. Patient must be competent to sign an informed consent form before study entry.
• • Exclusion Criteria
• Subjects who meet any of the following criteria are to be excluded from this study:
• • 1. Corneal disease or corneal disorder in either eye.
• • 2. Any active ocular surface disease of any severity.
• • 3. Increased IOP (above 20 mm Hg), glaucoma or history of glaucoma.
• • 4. Previous corneal surgery in the eye to be treated.
• • 5. Conjunctivochalasis
• • 6. Nystagnus
• • 7. Diabetes
• • 8. Pregnancy
• • 9. Presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable as a candidate for study participation or that may confound the outcome of the study.
• • nclusion Criteria: -
• Exclusion Criteria:
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