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》

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 《-》

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 ... -  《-》

Long-term outcomes after monocular corneal inlay implantation for the surgical compensation of presbyopia.

To evaluate long-term outcomes of small-aperture corneal inlay implantation for the surgical compensation of presbyopia. Paracelsus Medical University, Salzburg, Austria. Prospective interventional cohort study. Monocular implantation of a Kamra small-aperture inlay (model ACI7000) (1.6 mm central aperture) was performed in emmetropic presbyopic eyes. The preoperative and postoperative parameters included monocular and binocular uncorrected (UDVA) and corrected (CDVA) distance visual acuities, uncorrected intermediate visual acuity (UIVA), and uncorrected (UNVA) and corrected (CNVA) near visual acuities; refraction; patient satisfaction; and complications. From September 4, 2006, to May 21, 2007, a small-aperture inlay (1.6 mm central aperture) was implanted in 32 emmetropic presbyopic eyes. The mean binocular uncorrected visual acuities improved as follows: UNVA from Jaeger (J) 6 ± 1.2 lines (∼20/50) to J2 ± 1.8 lines (∼20/25) (P < .001) and UIVA from 0.2 logMAR ± 1.3 lines (∼20/32) to 0.1 logMAR ± 1.3 lines (∼20/25) (P = .04). The UDVA decreased from -0.2 logMAR ± 0.2 lines (∼20/12.5) to -0.1 logMAR ± 0.6 lines (∼20/16) (P < .001). At 60 months, 74.2% of patients had a UNVA of J3 (∼20/32) or better, 87.1% had a UIVA of 0.2 logMAR (∼20/32) or better, and 93.5% had a UDVA of 0.0 logMAR (∼20/20) or better. One inlay was removed after 36 months because of patient dissatisfaction with vision after a hyperopic shift in the surgical eye, with no loss of CDVA or CNVA 2 years after removal. Long-term results of monocular corneal inlay implantation indicate increased UNVA and UIVA and slightly compromised UDVA in emmetropic presbyopic eyes. Dr. Grabner was reimbursed for travel expenses from Acufocus. Dr. Riha is a consultant to Acufocus. No other author has a financial or proprietary interest in any material or method mentioned.

Dexl AK ，Jell G ，Strohmaier C ，Seyeddain O ，Riha W ，Rückl T ，Bachernegg A ，Grabner G ... -  《-》