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 ... -  《-》

Small-aperture corneal inlay for the correction of presbyopia: 3-year follow-up.

To report the 3-year postoperative safety and efficacy outcomes of the Acufocus corneal inlay. University Eye Clinic, Paracelsus Medical University, Salzburg, Austria. Prospective nonrandomized noncomparative cohort study. The corneal inlay was implanted in the nondominant eye of naturally emmetropic presbyopic patients. Refraction, uncorrected near (UNVA), intermediate (UIVA), and distance (UDVA) visual acuities; corrected distance visual acuity (CDVA); contrast sensitivity; visual fields; subjective patient satisfaction and symptoms; and operative and postoperative adverse events and complications were evaluated. The study enrolled 32 patients. The mean UNVA improved from Jaeger (J) 6 preoperatively to J1 at 3 years and the mean UIVA, from 20/40 to 20/25, respectively. At 3 years, 97% of eyes had a UNVA of J3 or better and 91% had a UIVA of 20/32 or better. The mean UDVA was 20/20, with all eyes achieving 20/32 or better. Nine eyes (28.3%) lost 1 line of CDVA, 1 eye (3.1%) lost more than 2 lines (3.8 lines), and 3 eyes (9.3%) gained 1 line. No inlay was explanted, and no inflammatory reactions were observed. At 3 years, 15.6% of patients reported severe night-vision problems and 6.3% (versus 87.5% preoperatively) reported being dependent on reading glasses. These 3-year results support the safety and efficacy of the corneal inlay to correct presbyopia in naturally emmetropic presbyopic patients. However, despite a significant gain in UNVA and UIVA, 28.3% of patients lost 1 line of CDVA.

Seyeddain O ，Hohensinn M ，Riha W ，Nix G ，Rückl T ，Grabner G ，Dexl AK ... -  《-》

One-year visual outcomes and patient satisfaction after surgical correction of presbyopia with an intracorneal inlay of a new design.

To evaluate the safety and efficacy of the third-generation Kamra corneal inlay (ACI 7000PDT) implanted monocularly in corneal pockets of emmetropic presbyopic patients to improve near and intermediate vision. University Eye Clinic, Paracelsus Medical University, Salzburg, Austria. Cohort study. The corneal inlay was implanted in the nondominant eye over the line of sight by creating a corneal pocket with a femtosecond laser. The minimum postoperative follow-up was 12 months. Distance, intermediate, and near visual acuities were assessed over the follow-up. Other examinations included slitlamp evaluation, central keratometry, computerized corneal topography, endothelial cell count, and central corneal thickness. Patients completed satisfaction questionnaires preoperatively and 3, 6, and 12 months postoperatively. The study evaluated 24 patients. After a mean follow-up of 12 months, 92% of patients read Jaeger (J) 3 or better with the surgical eye, the mean binocular uncorrected near visual acuity improved from J5 preoperatively to J2, and the mean binocular uncorrected intermediate visual acuity was 20/20 (67% ≥ 20/20). At 12 months, the mean uncorrected distance visual acuity was 20/20 in the surgical eye and 20/16 binocularly. Patients reported no change in distance vision, and their need for reading glasses decreased significantly (P<.001). No inlay was explanted and or recentered during the reported follow-up. The new corneal inlay was a safe and effective treatment for presbyopia over a 1-year follow-up.

Dexl AK ，Seyeddain O ，Riha W ，Hohensinn M ，Rückl T ，Reischl V ，Grabner G ... -  《-》

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 《-》