PURPOSE To evaluate the safety and efficacy of the VIS Optimal Keratoplasty (Opti-K) device and procedure for treating eyes with emmetropic presbyopia to achieve uncorrected near visual acuity (UNVA) improvement.

SETTING Bahamas Vision Centre, Nassau, New Providence, The Bahamas

METHODS 145 eyes of 75 patients with emmetropic presbyopia (MRSE = -0.25 to +0.75 D; mean add and standard deviation (SD) = 1.89 (0.35 D) received primary treatments (Txs) by the VIS NTK Optimal Keratoplasty (Opti-K) device; 66 and 16 eyes also received secondary and ternary Txs, respectively. Patients were treated to produce best uncorrected near visual acuity (UNVA) in both eyes using a multifocal vision protocol. Safety and efficacy measures with follow-up (f/u) extending to 24 months post-Tx were analyzed.

RESULTS Safety - There were no clinically significant adverse events or complications. Changes in intraocular pressure (IOP) and astigmatism (A) were not statistically significant (p < 0.05). Increase of central corneal thickness (CCT) was not clinically significant.

Efficacy - Geometric mean (gm) (SD) binocular UNVA improvements corresponded to 4.0 (2.0) lines gained at 1day′ post-secondary Tx (p < 10-6), with gradual reduction of improvement to 1.8 (1.5) lines gained at 24m′ (p = 0.002). Gm UDVA was conserved or even improved at most f/u times. Patient neuroadaptation to multifocality occurred immediately post-Tx. Mean durations (SD) of functional (>20/40) binocular UNVA outcomes were 10.8 (9.1) m for primary Txs only and 15.2 (10.3)m for primary plus secondary Txs.

CONCLUSIONS In eyes with emmetropic presbyopia, optimal keratoplasty (Opti-K) is safe and efficacious for improving UNVA while retaining (or improving) UDVA. The procedure is noninvasive, simple, rapid, comfortable and repeatable. Although UNVA improvement is temporary, additional Opti-K Txs can be repeated whenever needed to maintain functional uncorrected near visual acuity.

PRÉCIS In a retrospective observational study, Optimal Keratoplasty (Opti-K), a noninvasive procedure for vision improvement, provided safe and efficacious multifocal vision to emmetropic presbyopes, who gained uncorrected near visual acuity while maintaining (or improving) uncorrected distance visual acuity.

Financial Disclosures: Dr. Rodgers has no financial or proprietary interest in any product, material or method mentioned. Dr. Rodgers received research support. Drs. Glen and Berry are consultants to VIS,Inc. and have a proprietary interest in the product and method mentioned.

NCT06702020

This study was funded by VIS, Incorporated.

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study used (or will use) ONLY simulated data or ONLY openly available human data that were originally located at Bahamas Vision Centre, Nassau, The Bahamas. The study protocol was approved by the Ethics Committee of the Bahamas Ministry of Health.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Supported by VIS, Inc., Plano, Texas, USA

Financial Disclosures: Dr. Rodgers has no financial or proprietary interest in any product, material or method mentioned. Dr. Rodgers received research support. Drs. Glen and Berry are consultants to VIS, Inc. and have a proprietary interest in the product and method mentioned.

Additional emails: Kjarodgersgmail.com (K.J.Rodgers) and oceans11bellsouth.net (H.G. Glen)

The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.