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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm treatment with the VIS Optimal Keratoplasty (Opti-Kâ„¢) System | Experimental | Subjects who accept monovision will receive Opti-Kâ„¢ treatment in the non-dominant eye. The fellow eye will not receive Opti-Kâ„¢ treatment in this Pivotal Study. Eligible subjects will undergo a single retreatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optimal laser keratoplasty | Device | Laser |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of eyes that achieve UNVA | Percentage of eyes that achieve UNVA of 20/40 or better and 20/20 or better | 3 months |
| Subjective improvement in vision | • Subjective improvement in visual experience as measured by subject satisfaction questionnaire related to near vision, distance vision, visual symptoms and overall satisfaction. |
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-Kâ„¢ 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.
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.
a. 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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristy Wort | Contact | â€(214) 855-1222‬ | kwort@totalcro.com | |
| George Aubrey | Contact | (724) 822-1838 | gaubrey@aol.com |
| Name | Affiliation | Role |
|---|---|---|
| Harry Glen, M.D. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cohen Laser & Vision Center | Recruiting | Boca Raton | Florida | 33431 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12414402 | Background | 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. | |
| Background | undefined | ||
| 19344821 |
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There is a plan to make IPD and related data dictionaries available.
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| 3 months |
| Claris Vision Eye Health | Recruiting | South Dartmouth | Massachusetts | 02747 | United States |
|
| The Cornea & Laser Eye Institute | Recruiting | Teaneck | New Jersey | 07666 | United States |
|
| OCLI Vision - Oceanside | Recruiting | Oceanside | New York | 11572 | United States |
|
| Background |
| 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. |