The VIS Opti-K Low Vision Aid Device Provides Vision Improvement.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorVIS, Inc.
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Vision improvement
DeviceVision improvement for patients with refractive disorders (hyperopia and presbyopia)
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Vision improvementExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Uncorrected Distance Visual Acuity (UDVA)
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.
Time frame
Up to 24 months post-treatment2
Uncorrected Near Visual Acuity (UNVA)
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.
Time frame
Up to 24 months post-treatment Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: