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PresbyopiaPhase 3Opti-K™NCT06487897

Phase III Presbyopia Correction Using the VIS Opti-K™ System

A Phase 3 study testing Optimal laser keratoplasty in people with Presbyopia, run by VIS, Inc. at 4 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Presbyopia
What is being tested?
Optimal laser keratoplasty
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
4 sitesUnited States
Study dates
30 Sep 2024to Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • Best corrected near visual acuity (CNVA) of at least 20/20 in both eyes (LogMAR ≤ 0.00).
  • Subject has normal corneal topography.
  • Subject must have documented monovision tolerance (per Appendix B)
  • Subject is not a contact lens wearer or, if wearing contact lenses, has discontinued wearing contact lenses for the required period of time and completed the contact lens stability check as described below.
  • Contact Lens Wearers Only: Demonstration of a stable refraction, defined as two manifest refractions that are within ± 0.5 D MRSE of each other as determined under the following conditions: i. The two refractions are performed at least 7 days apart; and, ii. Contact lenses are not worn for at least the specified period prior to the first refraction used to establish stability and through the day of surgery:
  • Contact Lens Type Minimum Discontinuation Time Soft 3 Days Soft Extended Wear 1 Week Soft Toric 2 Weeks Rigid gas permeable 2 Weeks
  • Subject is willing and able to comply with all pre-treatment and follow-up requirements, including the ability to read English to complete the PROWL questionnaire
  • Subject understands the nature of the procedure, as well as potential risks or limitations of the treatment, and provides informed consent.
  • Subject will make every effort to have no other refractive or ocular surgery during their study post-treatment follow-up period.

Who cannot join

  • 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.
  • 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.
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  • 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.
  • Subjects with a recent history (within one week prior to treatment) of using topical ophthalmic medications containing preservatives (such as benzalkonium chloride, except for medications specifically required in this protocol) and/or other ocular drugs that are cytotoxic.
  • Those with ocular manifestations of acute or chronic illness that might increase the risk or confound the outcome of the study (e.g., diagnosed autoimmune disease, systemic connective tissue disease, clinically significant atopic disease, unstable diabetes mellitus and all diabetes with ocular involvement, etc.).
  • Pregnant, planning to become pregnant, or lactating women.
  • Subjects participating in other ophthalmic clinical trials during this clinical investigation.
  • Persons who, in the determination of the investigator, are not competent to understand the procedure or the actions asked of them as research subjects or have unrealistic expectations or are considered emotionally labile.
  • Persons who may not be able to complete the requirements of returning to the investigator's clinic over the period of the study, or who may be difficult to locate or contact on short notice. This does not preclude vacations or travel.
  • Subjects who are likely to be exposed to high levels of ultraviolet radiation (from sunlight, tanning lights, etc.) without protective eyewear during the one- year period following Opti-K™ treatment.
  • Presence or history of any other condition or finding that, in the opinion of the investigator, makes the subject unsuitable as a candidate for Opti-K™ treatment or study participation or may confound the outcome of the study.
  • Presence of a pupil irregularity (e.g., decentered pupil or irregular shape) in the eye to be treated that could predispose the eye to a centration error during the treatment.
  • Previous intraocular or corneal surgery of any kind in either eye, including any type of surgery for either refractive or therapeutic purposes.
  • Subjects using topical ophthalmic medications to treat presbyopia or plan to use these medications during the study follow-up period.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kristy Wort contact

‭(214) 855-1222‬

kwort@totalcro.com

George Aubrey contact

(724) 822-1838

gaubrey@aol.com

United States4 sites, 4 recruiting

  • Cohen Laser & Vision Center

    Boca Raton, Florida, 33431

    Joshua Cohen, M.D., 561-981-8400, joshua@cohenlaser.com

    Joshua Cohen, M.D.

    Recruiting

  • OCLI Vision - Oceanside

    Oceanside, New York, 11572

    Isabel Lezcano, 516-593-4026, ilezcano@ocli.net

    Marguerite McDonald, M.D.

    Recruiting

  • Claris Vision Eye Health

    South Dartmouth, Massachusetts, 02747

    Charlotte Friedman, 508-994-1400 ext. 2105, cfriedman@centuryvisionglobal.com

    David Kielty, M.D.

    Recruiting

  • The Cornea & Laser Eye Institute

    Teaneck, New Jersey, 07666

    Peter Hersh, M.D., 201-692-9434, phersh@vision-institute.com

    Peter Hersh, M.D.

    Recruiting

Other trials in United States

About this study

Official title: Phase III Presbyopia Correction Using the VIS Optimal Keratoplasty (Opti-K™) System (Phase IIIa)

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
Presbyopia
Being tested
Optimal laser keratoplasty
Keywords
Presbyopia,, Near Vision, Monovision, UNVA
Medical subject headings
Presbyopia, Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Optimal laser keratoplastyDevice

    Laser

Study groups in NCT06487897
Study groupRoleWhat they receive
Single arm treatment with the VIS Optimal Keratoplasty (Opti-K™) SystemExperimentalSubjects who accept monovision will receive Opti-K™ treatment in the non-dominant eye. The fellow eye will not receive Opti-K™ treatment in this Pivotal Study. Eligible subjects will undergo a single retreatment
Receives: Device: Optimal laser keratoplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3 months

Secondary outcomes (1)

  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

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2024
  2. Study start30 Sep 2024 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06487897
Sponsor's protocol ID
OK-004
Acronym
Opti-K™
Status last verified
Aug 2024
First submitted
27 Jun 2024
Last updated
5 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: There is a plan to make IPD and related data dictionaries available.

Publications

  • McDonald MB, Hersh PS, Manche EE, Maloney RK, Davidorf J, Sabry M; Conductive Keratoplasty United States Investigators Group. Conductive keratoplasty for the correction of low to moderate hyperopia: U.S. clinical trial 1-year results on 355 eyes. Ophthalmology. 2002 Nov;109(11):1978-89; discussion 1989-90. doi: 10.1016/s0161-6420(02)01255-1.

    PubMed 12414402

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  • Solomon KD, Fernandez de Castro LE, Sandoval HP, Biber JM, Groat B, Neff KD, Ying MS, French JW, Donnenfeld ED, Lindstrom RL; Joint LASIK Study Task Force. LASIK world literature review: quality of life and patient satisfaction. Ophthalmology. 2009 Apr;116(4):691-701. doi: 10.1016/j.ophtha.2008.12.037.

    PubMed 19344821

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Optimal laser keratoplasty in people with Presbyopia, run by VIS, Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kristy Wort (‭(214) 855-1222‬, kwort@totalcro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Uncorrected near visual acuity 2 or more lines or better (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06487897, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024; AzTrials last refreshed its copy on 26 Oct 2026.

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