Phase III Presbyopia Correction Using the VIS Opti-K™ System
ConditionPresbyopia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40+
SponsorVIS, Inc.
About this trial
The goal of this clinical trial is to evaluate the safety and efficacy of using the VIS Opti-K System to enable monovision by providing temporary improvement in near vision through the treatment of the non-dominant eye of low myopic, emmetropic and low hyperopic presbyope subjects. The main questions it aims to answer are determining uncorrected near visual acuity at 40cm in the treated eye and subjective improvement as measured by the patient satisfaction questionnaire.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject age is equal to or greater than 40 years old.
Subjects must have a manifest refraction spherical equivalent (MRSE) between -0.5 D and +0.25 D with no more than 0.75 D of refractive cylinder needing +1.00 D to +2.50 D of reading add in both eyes.
Documented stable refractions defined as 0.5 D or less change in MRSE per year for 12 months or longer prior to primary Opti-K™ treatment, based on refractions, medical records, or prescription history.
Uncorrected distance visual acuity (UDVA) 20/25 or better (i.e., LogMAR ≤ 0.10) in both eyes.
Disqualifiers
Latent hyperopia 1.0 D (i.e., baseline MRSE and CRSE should not differ by or be more than 1.0 D or CRSE).
Nystagmus.
Significant conjunctivochalasis defined as laxity and/or looseness of the conjunctiva when traction is applied and/or redundancy in its normal state. If there is no redundancy of the conjunctiva under normal conditions, there should be no more than 3 mm of conjunctival movement on the bulbar surface in the cardinal fields of gaze and/or by displacement for the patient to qualify for enrollment.
Any active ocular surface disease of any severity.
Trial design
Design model
Single group
Treatments tested in this trial
Optimal laser keratoplasty
DeviceLaser
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: Single arm treatment with the VIS Optimal Keratoplasty (Opti-K™) SystemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Uncorrected near visual acuity 2 or more lines or better
• The proportion of treated eyes (target: at least 50%) that achieve an uncorrected near visual acuity (UNVA) that is 2 or more lines better than Screening following treatment
Time frame
3 monthsSecondary outcomes
1
Binocular uncorrected near visual acuity
The proportion of eyes (target: at least 50%) that achieve a binocular uncorrected near visual acuity (UNVA) of 20/40 or better after the treatment
Time frame
3 monthsOther outcomes
1
Percentage of eyes that achieve UNVA
Percentage of eyes that achieve UNVA of 20/40 or better and 20/20 or better
Time frame
3 months2
Subjective improvement in vision
• Subjective improvement in visual experience as measured by subject satisfaction questionnaire related to near vision, distance vision, visual symptoms and overall satisfaction.
Time frame
3 months Source ClinicalTrials.gov