The VIS Opti-K Low Vision Aid Device Provides Vision Improvement.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vision improvement.
- Who it may be relevant to
- Registry conditions: Hyperopia, Presbyopia. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Vision Improvement for Patients With Presbyopia
Overview
The VIS Opti-K Low Vision Aid device will be used to provide vision improvement to patients with refractive disorders (hyperopia and presbyopia).
Interventions
- Device Vision improvement
Vision improvement for patients with refractive disorders (hyperopia and presbyopia)
Primary outcome measures
- Uncorrected Distance Visual Acuity (UDVA) [Time frame: Up to 24 months post-treatment]
- Uncorrected Near Visual Acuity (UNVA) [Time frame: Up to 24 months post-treatment]
Eligibility criteria
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
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- VIS, Inc. — Austin
Canada · 1 center
- Clarity Eye Institute — Toronto
Identifiers
NCT: NCT06597292 · VIS Opti-K-Presbyopia #001