RECRUITING

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

Conditions

Presbyopia Presbyopia,Near Vision Monovision UNVA

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-09-30

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06487897

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subject age is equal to or greater than 40 years old. 2. 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. 3. 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. 4. Uncorrected distance visual acuity (UDVA) 20/25 or better (i.e., LogMAR ≤ 0.10) in both eyes. 5. Best corrected distance visual acuity (CDVA) of 20/20 or better (i.e., LogMAR ≤ 0.00) in both eyes. 6. Uncorrected near visual acuity (UNVA) between 20/50 (LogMAR 0.40) and better than 20/100 (LogMAR \< 0.70) in the non-dominant eye. 7. Best corrected near visual acuity (CNVA) of at least 20/20 in both eyes (LogMAR ≤ 0.00). 8. Subject has normal corneal topography. 9. Subject must have documented monovision tolerance (per Appendix B) 10. 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. 11. 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 12. Subject understands the nature of the procedure, as well as potential risks or limitations of the treatment, and provides informed consent. 13. Subject will make every effort to have no other refractive or ocular surgery during their study post-treatment follow-up period.	1. Latent hyperopia 1.0 D (i.e., baseline MRSE and CRSE should not differ by or be more than 1.0 D or CRSE). 2. Nystagmus. 3. 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. 4. Any active ocular surface disease of any severity. 5. Any condition causing a cloudy cornea (e.g., scarring, dystrophies, epithelial or stromal edema) or cloudy anterior chamber. 6. Allergy to anesthetics or post-treatment medications, including NSAIDS. 7. 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. 8. 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. 9. 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. 10. 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.). 11. Pregnant, planning to become pregnant, or lactating women. 12. Subjects participating in other ophthalmic clinical trials during this clinical investigation. 13. 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. 14. 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. 15. 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. 16. 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. 17. 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. 18. Previous intraocular or corneal surgery of any kind in either eye, including any type of surgery for either refractive or therapeutic purposes. 19. Subjects using topical ophthalmic medications to treat presbyopia or plan to use these medications during the study follow-up period.

Inclusion Criteria

Exclusion Criteria

1. Subject age is equal to or greater than 40 years old.
2. 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.
3. 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.
4. Uncorrected distance visual acuity (UDVA) 20/25 or better (i.e., LogMAR ≤ 0.10) in both eyes.
5. Best corrected distance visual acuity (CDVA) of 20/20 or better (i.e., LogMAR ≤ 0.00) in both eyes.
6. Uncorrected near visual acuity (UNVA) between 20/50 (LogMAR 0.40) and better than 20/100 (LogMAR \< 0.70) in the non-dominant eye.
7. Best corrected near visual acuity (CNVA) of at least 20/20 in both eyes (LogMAR ≤ 0.00).
8. Subject has normal corneal topography.
9. Subject must have documented monovision tolerance (per Appendix B)
10. 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.
11. 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
12. Subject understands the nature of the procedure, as well as potential risks or limitations of the treatment, and provides informed consent.
13. Subject will make every effort to have no other refractive or ocular surgery during their study post-treatment follow-up period.

1. Latent hyperopia 1.0 D (i.e., baseline MRSE and CRSE should not differ by or be more than 1.0 D or CRSE).
2. Nystagmus.
3. 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.
4. Any active ocular surface disease of any severity.
5. Any condition causing a cloudy cornea (e.g., scarring, dystrophies, epithelial or stromal edema) or cloudy anterior chamber.
6. Allergy to anesthetics or post-treatment medications, including NSAIDS.
7. 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.
8. 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.
9. 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.
10. 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.).
11. Pregnant, planning to become pregnant, or lactating women.
12. Subjects participating in other ophthalmic clinical trials during this clinical investigation.
13. 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.
14. 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.
15. 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.
16. 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.
17. 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.
18. Previous intraocular or corneal surgery of any kind in either eye, including any type of surgery for either refractive or therapeutic purposes.
19. Subjects using topical ophthalmic medications to treat presbyopia or plan to use these medications during the study follow-up period.

Contacts and Locations

Study Contact

Kristy Wort

CONTACT

‭(214) 855-1222‬

kwort@totalcro.com

George Aubrey

CONTACT

(724) 822-1838

gaubrey@aol.com

Principal Investigator

Harry Glen, M.D.

STUDY_DIRECTOR

Study Locations (Sites)

Cohen Laser & Vision Center

Boca Raton, Florida, 33431

United States

Claris Vision Eye Health

South Dartmouth, Massachusetts, 02747

United States

The Cornea & Laser Eye Institute

Teaneck, New Jersey, 07666

United States

OCLI Vision - Oceanside

Oceanside, New York, 11572

United States

Collaborators and Investigators

Sponsor: VIS, Inc.

Harry Glen, M.D., STUDY_DIRECTOR

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-30

Study Completion Date2027-12

Study Record Updates

Study Start Date2024-09-30

Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

Presbyopia,
Near Vision
Monovision
UNVA

Additional Relevant MeSH Terms

Presbyopia