Phase III Presbyopia Correction Using the VIS Opti-Kâ„¢ System (NCT06487897) | Clinical Trial Compass
RecruitingPhase 3
Phase III Presbyopia Correction Using the VIS Opti-Kâ„¢ System
United States75 participantsStarted 2024-09-30
Plain-language summary
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.
Who can participate
Age range40 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. Best corrected distance visual acuity (CDVA) of 20/20 or better (i.e., LogMAR ≤ 0.00) in both eyes.
✓. Uncorrected near visual acuity (UNVA) between 20/50 (LogMAR 0.40) and better than 20/100 (LogMAR \< 0.70) in the non-dominant eye.
✓. Best corrected near visual acuity (CNVA) of at least 20/20 in both eyes (LogMAR ≤ 0.00).
✓. Subject has normal corneal topography.
Exclusion criteria
✕. 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.
What they're measuring
1
Uncorrected near visual acuity 2 or more lines or better
✕. Any active ocular surface disease of any severity.
✕. Any condition causing a cloudy cornea (e.g., scarring, dystrophies, epithelial or stromal edema) or cloudy anterior chamber.
✕. Allergy to anesthetics or post-treatment medications, including NSAIDS.
✕. History or current evidence of chronic allergic reactions, tearing and/or ocular irritation that might confound the outcome or increase the risk of the study.
✕. The use of systemic medications that may confound the outcome or increase the risk of the study, including, but not limited to corticosteroids, antimetabolites, amiodarone, chloroquine, isotretinoin, sumatriptan, or other medications that may affect healing.