Actively Recruiting
Phase III Presbyopia Correction Using the VIS Opti-K™ System
Led by VIS, Inc. · Updated on 2024-09-05
75
Participants Needed
4
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase III Presbyopia Correction Using the VIS Opti-K™ System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 years or older
- Manifest refraction spherical equivalent between -0.5 D and +0.25 D with no more than 0.75 D of refractive cylinder
- Reading addition between +1.00 D and +2.50 D in both eyes
- Stable refraction with 0.5 D or less change in MRSE per year for at least 12 months
- Uncorrected distance visual acuity of 20/25 or better in both eyes
- Best corrected distance visual acuity of 20/20 or better in both eyes
- Uncorrected near visual acuity between 20/50 and better than 20/100 in the non-dominant eye
- Best corrected near visual acuity of at least 20/20 in both eyes
- Normal corneal topography
- Documented tolerance for monovision
- Not currently wearing contact lenses or have discontinued them for required periods with stable refraction verified
- Willing and able to comply with study requirements including reading English questionnaires
- Understands and consents to the procedure and potential risks
- Will avoid other refractive or ocular surgery during study follow-up period
You will not qualify if you...
- Latent hyperopia greater than 1.0 D difference between baseline MRSE and corrected MRSE
- Nystagmus
- Significant conjunctivochalasis with excessive conjunctival looseness or movement
- Any active ocular surface disease
- Cloudy cornea or cloudy anterior chamber
- Allergy to anesthetics or post-treatment medications including NSAIDs
- Chronic allergic reactions or ocular irritation that could affect outcomes
- Use of systemic medications that may affect healing or study results
- Recent use of topical ophthalmic medications with preservatives that are cytotoxic
- Ocular manifestations of systemic diseases such as autoimmune disease or unstable diabetes with eye involvement
- Pregnant, planning pregnancy, or breastfeeding
- Participation in other ophthalmic clinical trials
- Inability to understand the procedure or unrealistic expectations
- Unlikely to complete follow-up visits or hard to contact
- Likely exposure to high ultraviolet radiation without protective eyewear during one-year follow-up
- Any condition deemed unsuitable by investigator for study participation or that could confound results
- Pupil irregularities that could cause treatment errors
- Previous intraocular or corneal surgery in either eye
- Use of topical medications to treat presbyopia or plans to use them during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Cohen Laser & Vision Center
Boca Raton, Florida, United States, 33431
Actively Recruiting
2
Claris Vision Eye Health
South Dartmouth, Massachusetts, United States, 02747
Actively Recruiting
3
The Cornea & Laser Eye Institute
Teaneck, New Jersey, United States, 07666
Actively Recruiting
4
OCLI Vision - Oceanside
Oceanside, New York, United States, 11572
Actively Recruiting
Research Team
K
Kristy Wort
CONTACT
G
George Aubrey
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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