Evaluating the short-term results of KAMRA inlay implantation using real-time optical coherence tomography-guided femtosecond laser technology.

To evaluate the outcomes from using real-time optical coherence tomography (OCT)-guided femtosecond laser technology for pocket creation for KAMRA inlay (Acufocus, Inc., Irvine, CA) implantation surgery. One hundred fifty-one eyes underwent KAMRA inlay implantation using the real-time OCT-guided femtosecond laser for pocket creation. All patients had a history of prior LASIK. Uncorrected distance visual acuity, corrected distance visual acuity, uncorrected near visual acuity, corrected near visual acuity, and manifest refraction spherical equivalent were evaluated preoperatively and postoperatively. The follow-up period was 3 months. Mean manifest refraction spherical equivalent, uncorrected distance visual acuity, and uncorrected near visual acuity changed from -0.18 ± 0.33 to -0.95 ± 0.64, 20/16 to 20/20, and J8 to J2, respectively. Corrected distance visual acuity and corrected near visual acuity remained stable before and after KAMRA inlay implantation, 20/12 and J1, respectively. Using real-time OCT-guided femtosecond laser technology increases the safety and accuracy of corneal KAMRA inlay implantation surgery with a history of prior LASIK with excellent visual and refractive outcomes.

Tomita M ，Huseynova T 《JOURNAL OF REFRACTIVE SURGERY》

Outcomes of small aperture corneal inlay implantation in patients with pseudophakia.

To evaluate the improvement in near visual acuity after KAMRA corneal inlay (AcuFocus, Inc., Irvine, CA) implantation in patients with pseudophakia. A retrospective study analysis of patients with pseudophakia undergoing monocular corneal inlay implantation in the non-dominant eye was performed. The inlay was implanted monocularly in the non-dominant eye of patients. Manifest refractive spherical equivalent, uncorrected distance visual acuity, corrected distance visual acuity, uncorrected near visual acuity, and corrected near visual acuity were evaluated. The follow-up period was 3 months. Thirteen eyes from 13 patients were evaluated. Four patients underwent LASIK for improved distance acuity at the time of inlay implantation. Mean uncorrected near visual acuity improved five lines (from J10 to J4) postoperatively. Mean uncorrected distance visual acuity, corrected distance visual acuity, and corrected near visual acuity remained stable and were 20/20, 20/16, and J1, respectively, before and after KAMRA implantation. Three eyes lost two lines and 1 eye lost one line of uncorrected distance visual acuity. Two eyes lost two lines and 1 eye lost 1 line of corrected distance visual acuity. Mean manifest refractive spherical equivalent changed before and after KAMRA implantation from -0.01 ± 1.07 diopters (D) (range: 2.25 to -1.88 D) to -1.12 ± 0.87 D (range: 0.25 to -2.75 D), respectively. Implantation of a small aperture corneal inlay improved uncorrected near visual acuity while maintaining uncorrected and corrected distance visual acuity in monofocal patients with pseudophakia.

Huseynova T ，Kanamori T ，Waring GO 4th ，Tomita M ... -  《JOURNAL OF REFRACTIVE SURGERY》

Small-aperture corneal inlay implantation to treat presbyopia after laser in situ keratomileusis.

To evaluate the visual outcomes after implantation of a Kamra small-aperture corneal inlay into a femtosecond-created corneal pocket to treat presbyopia in patients who had previous laser in situ keratomileusis (LASIK). Private center, Tokyo, Japan. Prospective interventional case series. Post-LASIK presbyopic patients had inlay implantation into a corneal pocket created by a femtosecond laser at a depth of 200 μm or 250 μm a minimum of 80 μm below the previous LASIK flap interface in the nondominant eye. Uncorrected and corrected distance visual acuities, near visual acuity, and a patient questionnaire on satisfaction, the use of reading glasses, and visual symptoms were evaluated. The study enrolled 223 eyes (223 patients) with a mean age of 53.6 years (range 44 to 65 years) and a mean manifest spherical equivalent of -0.18 diopter (D) (range -1.00 to +0.50 D). The mean uncorrected distance visual acuity in the operated eye decreased 1 line from 20/16 preoperatively to 20/20 6 months postoperatively (P<.001). The mean uncorrected near visual acuity improved 4 lines from Jaeger (J) 8 to J2 (P<.001). At 6 months, significant improvements were observed in patient dependence on reading glasses and patient satisfaction with vision without reading glasses. The 6-month results suggest that implantation of a small-aperture inlay in post-LASIK presbyopic patients improves near vision with a minimal effect on distance vision, resulting in high patient satisfaction and less dependence on reading glasses. Drs. Tomita and Waring are consultants to Acufocus, Inc. Dr. Tomita is a consultant to Ziemer Group AG. No other author has a financial or proprietary interest in any material or method mentioned.

Tomita M ，Kanamori T ，Waring GO 4th ，Nakamura T ，Yukawa S ... -  《-》

Femtosecond laser-assisted small-aperture corneal inlay implantation for corneal compensation of presbyopia: two-year follow-up.

To report the 2-year postoperative safety and efficacy outcomes after monocular Kamra corneal inlay (ACI7000PDT) implantation in femtosecond laser-created corneal pockets of emmetropic presbyopic patients to improve near and intermediate vision. University Eye Clinic, Paracelsus Medical University, Salzburg, Austria. Prospective interventional case series. Patients had corneal inlay implantation in the nondominant eye. Emmetropic presbyopic patients between 45 and 60 years old with an uncorrected distance visual acuity (UDVA) of 20/20 or better in both eyes and without additional ocular pathology were eligible. Contrast sensitivity, visual field examinations, endothelial cell count (ECC), and central corneal thickness (CCT) measurements were assessed preoperatively and 12 and 24 months postoperatively. The UDVA, uncorrected intermediate visual acuity (UIVA), and near visual acuity (UNVA) were assessed preoperatively and 1 day, 1 week, and 1, 3, 6, 9, 12, 18, and 24 months postoperatively. The minimum postoperative follow-up was 24 months. After 24 months, the mean binocular UNVA improved from 20/50 to 20/25; 20 patients (83%) had a UNVA of 20/25 or better. The mean binocular UIVA was 20/20. The mean UDVA was 20/20 in the surgical eye and 20/16 binocularly after 24 months. Contrast sensitivity under photopic and mesopic conditions remained in the range of the normal population. No patient had detectable central visual field defect. No inlay was explanted. No inflammatory reactions were observed. The ECC and CCT remained stable. The corneal inlay implanted in femtosecond laser-created pockets was effective and safe for the corneal compensation of presbyopia in emmetropic patients after 24 months. Acufocus Inc., Irvine, California, USA, financially supports the Research Foundation for Promoting Ophthalmology, Salzburg, Austria, as the clinical research center of the University Eye Clinic (Paracelsus Medical University). Dr. Grabner received travel expenses from Acufocus, Inc. Dr. Riha currently also works as a clinical application specialist for Acufocus, Inc. No other author has a financial or proprietary interest in any material or method mentioned.

Seyeddain O ，Bachernegg A ，Riha W ，Rückl T ，Reitsamer H ，Grabner G ，Dexl AK ... -  《-》

Correction of presbyopia with a small aperture corneal inlay.

To assess the efficacy of a small aperture corneal inlay (KAMRA, AcuFocus Inc) to improve near vision in emmetropic presbyopes. Prospective, nonrandomized, multicenter clinical trial in presbyopic emmetropes aged 45 to 60 years. A small corneal pocket or flap was created in the nondominant eye by femtosecond laser or mechanical microkeratome, and the inlay (N=507) placed on the stromal bed. Uncorrected visual acuity was measured for the implanted eye at near (40 cm), intermediate (80 cm), and distance (20 ft) using ETDRS charts with the Optec 6500 Vision Tester (Stereo Optical Inc) at the preoperative, and 1-, 3-, 6-, 9-, 12-, and 18-month postoperative examinations. Contrast sensitivity (CS) was measured with best distance correction in the implanted eye using the Optec system and FACT chart under photopic (85 cd/m(2)) and mesopic (3 cd/m(2)) conditions preoperatively and at 1-year follow-up. Mean patient age was 52.87±3.64 years. Monocular mean uncorrected near visual acuity was J8 (0.482±0.925 logMAR) preoperatively, J3 (0.185±0.848 logMAR) at 1 month (n=506, P<.0001), and J2 (0.139±0.851 logMAR) at 18 months (n=99, P<.0001). Mean uncorrected intermediate visual acuity was 20/35 (0.239±0.837 logMAR) preoperatively and 20/26 (0.139±0853 logMAR) at 18 months (P<.0001). Mean uncorrected distance visual acuity (UDVA) was 20/20 (0.011±0.890 logMAR) at 18 months. Photopic (P<.001) and mesopic (P<.0001) monocular contrast sensitivities were within the range of the normal population at 1 year. The KAMRA corneal inlay improved near visual acuity with minimal impact on UDVA or mesopic contrast sensitivity in the implanted eye.

Waring GO 4th 《JOURNAL OF REFRACTIVE SURGERY》