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
Qualifiers
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
Treatments tested in this trial
- Optimal laser keratoplasty
Treatment groups
75 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov