Status:
NOT_YET_RECRUITING
The VIS Opti-K Low Vision Aid Device Provides Vision Improvement.
Lead Sponsor:
VIS, Inc.
Conditions:
Hyperopia
Presbyopia
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
The VIS Opti-K Low Vision Aid device will be used to provide vision improvement to patients with refractive disorders (hyperopia and presbyopia).
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Subjects who meet all of the following criteria are candidates for this study:
- 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.
- Patient has best corrected near visual acuity (CNVA) of at least 20/20 (LogMAR ≤ 0.00) in eye(s) to be treated.
- Patient requires reading adds of +1.0 to +3.0 D in eye(s) to be treated.
- Patient is not a contact lens (CL) wearer.
- Patient has normal corneal topography.
- Patient is willing and able to comply with all examinations.
- 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:
- Corneal disease or corneal disorder in either eye.
- Any active ocular surface disease of any severity.
- Increased IOP (above 20 mm Hg), glaucoma or history of glaucoma.
- Previous corneal surgery in the eye to be treated.
- Conjunctivochalasis
- Nystagnus
- Diabetes
- Pregnancy
- 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:
- \-
Exclusion
Key Trial Info
Start Date :
September 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06597292
Start Date
September 16 2024
End Date
December 30 2026
Last Update
September 25 2024
Active Locations (2)
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1
VIS, Inc.
Austin, Texas, United States, 78731
2
Clarity Eye Institute
Toronto, Ontario, Canada, L4K 0J4