Overcoming Emmetropic Presbyopia by Optimal Keratoplasty (Opti-K)
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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.
