Conductive keratoplasty for the correction of low to moderate hyperopia: U.S. clinical trial 1-year results on 355 eyes.
Marguerite B McDonald, Peter S Hersh, Edward E Manche...
https://pubmed.ncbi.nlm.nih.gov/12414402Actively Recruiting
Phase 3
Age: 40Years +
All Genders
ID06487897
Phase III Presbyopia Correction Using the VIS Optimal Keratoplasty (Opti-K) System (Phase IIIa)
Led by VIS, Inc. · Updated on 2024-09-05
75
Participants Needed
4
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of the VIS Opti-K System in improving near vision temporarily by treating the non-dominant eye of adults with presbyopia who have low myopia, emmetropia, or low hyperopia. The study focuses on measuring uncorrected near visual acuity at 40cm and patients' subjective satisfaction with their vision. It is a Phase III clinical trial led by VIS, Inc., targeting adults aged 40 years and older. Participants who agree to monovision will receive a single treatment using the VIS Optimal Keratoplasty (Opti-K) System on their non-dominant eye. The other eye will not receive treatment during this pivotal study. Eligible subjects may undergo one retreatment if necessary to assess the device's impact on near vision. During the trial, participants will attend follow-up visits where their near visual acuity and binocular vision will be measured at three months after treatment. They will also complete satisfaction questionnaires to report their experience. The study monitors visual outcomes and safety over the follow-up period, with participation lasting at least three months after the initial treatment.
CONDITIONS
Brief Title
Phase III Presbyopia Correction Using the VIS Opti-K™ System
Who Can Participate
Age: 40Years +
All Genders
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 add between +1.00 D and +2.50 D in both eyes
- Stable refraction with 0.5 D or less change per year for at least 12 months prior to treatment
- 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 monovision tolerance
- No current contact lens use or discontinued contact lenses with documented stability
- Willingness and ability to comply with study requirements, including reading English questionnaires
- Informed consent given
- Commitment to avoid other refractive or ocular surgery during follow-up
You will not qualify if you...
- Latent hyperopia greater than 1.0 D difference between baseline MRSE and CRSE
- Nystagmus
- Significant conjunctivochalasis or conjunctival looseness
- Active ocular surface disease
- Cloudy cornea or anterior chamber conditions
- Allergy to anesthetics or post-treatment medications
- Chronic allergic reactions or ocular irritation
- Use of systemic medications that may affect healing
- Recent use of topical ophthalmic medications with preservatives
- Ocular manifestations of acute or chronic illness affecting study outcomes
- Pregnancy, planning pregnancy, or lactation
- Participation in other ophthalmic clinical trials
- Inability to understand or comply with study procedures
- Likely inability to complete study visits or be contacted
- High exposure to ultraviolet radiation without protective eyewear
- Any condition making the subject unsuitable for treatment or study
- Pupil irregularities that may affect treatment accuracy
- Previous intraocular or corneal surgery
- Use of topical ophthalmic medications to treat presbyopia during follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Single treatment with possible single retreatment
Participants receive the VIS Optimal Keratoplasty (Opti-K™) System treatment in the non-dominant eye, with a single retreatment if applicable.
1 to 2 visits depending on retreatment
Post-operative Follow-up
Duration - Approximately 3 months
Participants are monitored after treatment to assess uncorrected near visual acuity and safety.
Multiple visits over 3 months
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
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Research Team
K
Kristy Wort
G
George Aubrey
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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