Hyperopia, Presbyopia
Conditions
Keywords
Vision improvement
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).
Interventions
DEVICEVision improvement
Vision improvement for patients with refractive disorders (hyperopia and presbyopia)
Sponsors
VIS, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Patient IDs will be assigned and used.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
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: -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uncorrected Distance Visual Acuity (UDVA) | Up to 24 months post-treatment | Uncorrected distance visual acuity (UDVA) is to be measured and reported using standard ETDRS visual acuity charts. UDVA change from baseline is also to be reported. |
| Uncorrected Near Visual Acuity (UNVA) | Up to 24 months post-treatment | Uncorrected near visual acuity (UNVA) is to be measured and reported using standard near visual acuity charts. UNVA change from baseline is also to be reported. |
Countries
Canada, United States
Contacts
Primary ContactMichael Berry, PhD
Backup ContactHarry Glen, MD
Outcome results
None listed