Orang Seyeddain

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

PURPOSE: To report the 3‐year postoperative safety and efficacy outcomes of the Acufocus corneal inlay. SETTING: University Eye Clinic, Paracelsus Medical University, Salzburg, Austria. DESIGN: Prospective nonrandomized noncomparative cohort study. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. Financial Disclosure: Acufocus, Inc., California, USA, financially supports the Research Foundation for Promoting Opthhalmology, Salzburg, Austria, as the clinical research center of the University Eye Clinic, Paracelsus Medical University, Salzburg. Dr. Grabner received travel expenses from Acufocus, Inc. Dr. Riha currently works as a clinical application specialist for Acufocus, Inc. Drs. Seyeddain, Hohensinn, Nix, Rückl, and Dexl have no financial or proprietary interest in any material or method mentioned.

Reading performance after implantation of a small-aperture corneal inlay for the surgical correction of presbyopia: Two-year follow-up

PURPOSE: To evaluate the change in reading‐performance parameters after implantation of the Kamra small‐aperture intracorneal inlay over a 2‐year follow‐up. SETTING: University Eye Clinic, Paracelsus Medical University, Salzburg, Austria. DESIGN: Cohort study. METHODS: This study comprised naturally emmetropic presbyopic patients. Bilateral reading acuity, reading distance, reading speed, and the smallest log‐scaled sentence were evaluated in a standardized testing procedure using the Salzburg Reading Desk. The minimum postoperative follow‐up was 24 months. RESULTS: The study enrolled 32 patients. The reading desk results showed a significant improvement in each parameter tested. After a mean follow‐up of 24.2 months ± 0.8 (SD), the mean reading distance changed from the preoperative value of 48.1 ± 5.5 cm to 38.9 ± 6.3 cm (P < .0001), the mean reading acuity at best distance improved from 0.3 ± 0.14 logRAD to 0.24 ± 0.11 logRAD (P < .000001), and the mean reading speed increased from 142 ± 13 words per minute (wpm) to 149 ± 17 wpm (P=.029). One patient lost 1 line, and 1 patient had no change. The improvement was up to 6 log‐scaled lines (mean improvement 2.7 ± 1.6 lines) in the other 30 patients. CONCLUSIONS: After implantation of the small‐aperture intracorneal inlay, there was an improvement in all tested reading performance parameters in emmetropic presbyopic patients; the improvement was the result of an increased depth of field. These 2‐year results indicate that the inlay is an effective treatment for presbyopia. Financial Disclosure: Drs. Seyeddain, Riha, Hohensinn, and Hitzl have no financial or proprietary interest in any material or method mentioned. Additional disclosures are found in the footnotes.

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

PURPOSE: 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. SETTING: University Eye Clinic, Paracelsus Medical University, Salzburg, Austria. DESIGN: Cohort study. METHODS: 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. RESULTS: 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. CONCLUSION: The new corneal inlay was a safe and effective treatment for presbyopia over a 1‐year follow‐up. Financial Disclosure: Dr. Riha is a surgical advisor to Acufocus, Inc., Irvine, California, USA. No other author has a financial or proprietary interest in any material or method mentioned.

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

Purpose 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. Setting University Eye Clinic, Paracelsus Medical University, Salzburg, Austria. Design Prospective interventional case series. Methods 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. Results 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. Conclusion 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. Financial Disclosure 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.

Postoperative bilateral reading performance with 4 intraocular lens models: Six-month results

PURPOSE: To compare bilateral reading performance within the first 6 months after implantation of 4 intraocular lens (IOL) models. SETTING: Vissum‐Instituto de Oftalmológico de Alicante, Alicante, Spain, and University Eye Clinic, Paracelsus Medical University, Salzburg, Austria. DESIGN: Comparative case series. METHODS: Patients had bilateral phacoemulsification and implantation of Acri.Smart 48S monofocal, Acrysof Restor SN6AD3 apodized multifocal, Acri.LISA 366D diffractive multifocal, or Rezoom refractive multifocal IOLs. Bilateral reading performance with and without near correction was evaluated preoperatively and postoperatively using the Salzburg Reading Desk. RESULTS: The study comprised 304 eyes of 152 patients 51 to 90 years old. All groups had a significant improvement in uncorrected and corrected distance visual acuities postoperatively (P≤.01). The apodized multifocal and diffractive multifocal groups had significantly better uncorrected reading acuity than the monofocal and refractive multifocal groups 1 month and 6 months postoperatively (P<.01). Uncorrected reading speed was significantly worse in the refractive multifocal group than in the monofocal group at 1 month (P<.01). The monofocal group had the greatest uncorrected reading distance at 1 month and 6 months (P<.01). CONCLUSION: Multifocal IOLs with a diffractive component provided a comparable reading performance that was significantly better than the one obtained with refractive multifocal and monofocal IOLs. Financial Disclosure: Drs. Alió, Plaza‐Puche, Rasp, Piñero, Seyeddain, Rodríguez‐Prats, Ayala, Moreu, Hohensinn, and Riha have no financial or proprietary interest in any material or method mentioned. Additional disclosures are found in the footnotes.

Reading performance and patient satisfaction after corneal inlay implantation for presbyopia correction: Two-year follow-up

PURPOSE: To evaluate change in reading performance parameters after monocular Kamra corneal inlay implantation for the surgical correction of presbyopia. SETTING: University surgical outpatient center. DESIGN: Prospective interventional case series. METHODS: A corneal inlay was implanted in the nondominant eye. Naturally emmetropic and presbyopic patients between 45 years and 60 years old with an uncorrected distance visual acuity of at least 20/20 in both eyes without additional ocular pathology were eligible for inclusion. Bilateral uncorrected reading acuity, reading distance, mean and maximum reading speed, and the smallest log‐scaled print size (lower case letter of a Radner reading chart) were evaluated using the Salzburg Reading Desk. The minimum postoperative follow‐up was 24 months. RESULTS: Twenty‐four patients were enrolled. The mean reading distance was 46.7 cm ± 6.3 (SD) preoperatively and 39.5 ± 6.4 cm 24 months postoperatively (P<.001). The mean reading acuity at best distance improved (0.33 ± 0.13 logRAD versus 0.23 ± 0.11 logRAD) (P=.004). The mean reading speed increased from 141 ± 20 words per minute (wpm) to 146 ± 20 wpm, respectively (P=.261), and the mean maximum reading speed from 171 ± 28 wpm to 180 ± 22 wpm, respectively (P=.110). The smallest print size improved from 1.50 ± 0.42 mm to 1.01 ± 0.22 mm, respectively (P<.001). CONCLUSION: Improving the depth of focus by monocular implantation of a small‐aperture optic caused statistically significant changes in all tested reading performance parameters except reading speed metrics in emmetropic presbyopic patients. Financial Disclosure: AcuFocus, Inc., Irvine, California, USA, financially supports the Fuchs‐Foundation for the Promotion of Ophthalmology as the clinical research center of the Department of Ophthalmology, Paracelsus Medical University, Salzburg, Austria. Drs. Dexl and Grabner are among the patent owners of the Salzburg Reading Desk technology. Dr. Grabner received travel expenses from AcuFocus, Inc. Dr. Riha currently works as a surgical advisor to AcuFocus, Inc. Drs. Seyeddain, Rückl, Bachernegg, Emesz, and Ruckhofer have no financial or proprietary interest in any material or method mentioned.

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

Purpose To evaluate long‐term outcomes of small‐aperture corneal inlay implantation for the surgical compensation of presbyopia. Setting Paracelsus Medical University, Salzburg, Austria. Design Prospective interventional cohort study. Methods 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. Results 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. Conclusion Long‐term results of monocular corneal inlay implantation indicate increased UNVA and UIVA and slightly compromised UDVA in emmetropic presbyopic eyes. Financial Disclosure 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.

Bilateral reading performance of 4 multifocal intraocular lens models and a monofocal intraocular lens under bright lighting conditions.

PURPOSE: To compare changes in reading performance parameters after implantation of 4 multifocal intraocular lens (IOL) models and a monofocal IOL. SETTING: Department of Ophthalmology, Paracelsus Medical University, Salzburg, Austria. DESIGN: Prospective randomized controlled clinical trial. METHODS: Patients with bilateral cataract without additional ocular pathology were scheduled for bilateral implantation of Acri.Smart 48S monofocal, Acrysof Restor SN6AD3 apodized multifocal, AT LISA 366D diffractive multifocal, Tecnis ZMA00 diffractive multifocal, or Rezoom refractive multifocal IOLs. Bilateral corrected and uncorrected reading acuity, reading distance, mean and maximum reading speeds, and smallest log‐scaled print size of a Radner reading chart were evaluated under bright lighting conditions (500 lux) using the Salzburg Reading Desk. Pupil size was not measured throughout the trial. The minimum follow‐up was 12 months. RESULTS: The diffractive multifocal groups had significantly better uncorrected reading acuity and uncorrected smallest print size than the monofocal and refractive multifocal groups 1, 6, and 12 months postoperatively. The diffractive IOL groups had comparable uncorrected reading distance of approximately 32 cm, which was larger in the monofocal group (38.9 ± 8.4 cm) and refractive multifocal group (37.1 ± 7.3 cm) at the last visit. Patients with diffractive IOLs could read print sizes of approximately 0.74 to 0.87 mm, which was much better than in the monofocal and refractive multifocal groups. The diffractive AT LISA IOL provided the best reading speed values (mean and maximum, corrected and uncorrected). CONCLUSION: Multifocal IOLs with a diffractive component provided good reading performance that was significantly better than that obtained with a refractive multifocal or monofocal IOL. Financial Disclosure: Drs. Grabner and Dexl were patent owners of the Salzburg Reading Desk technology (now owned by SRD‐Vision, LLC). No other author has a financial or proprietary interest in any material or method mentioned.

Follow-up to “Central and Peripheral Corneal Iron Deposits After Implantation of a Small-aperture Corneal Inlay for Correction of Presbyopia”

PURPOSE To describe central and peripheral corneal iron deposition after implantation of the AcuFocus corneal inlay (ACI 7000, AcuFocus Inc) for the surgical correction of presbyopia. METHODS Patients who underwent inlay implantation between September 2006 and May 2007 and displaying corneal iron deposits were enrolled in the study. RESULTS Eighteen (56%) eyes of 32 patients developed corneal iron deposition within 36 months after corneal inlay implantation. One (5.5%) eye had a central spot-like iron deposition only, 10 (55.5%) eyes had formation of deposits in a half-moon shape in the inferior cornea parallel to the outer margin of the inlay or a complete circular ring formation, and 7 (39%) eyes demonstrated deposits in both areas. The median interval between implantation and diagnosis of corneal iron deposition was 18 ± 9 months. CONCLUSIONS Corneal iron deposition can develop in different shapes after implantation of the small-aperture ACI 7000. Alterations in tear film thickness, its composition, and corneal epithelial basal cell storage, resulting from changes in corneal topography, may be contributing factors for these specific iron depositions.

Profiles of Intraocular Pressure in Human Donor Eyes during Femtosecond Laser Procedures—A Comparative Study

PURPOSE To compare four different femtosecond laser devices (IntraLase FS, Zeiss VisuMAX, and Ziemer Femto LDV, and a prototype Schwind SmartTech Nanolaser) in human donor eyes with regard to their effects on IOP during femtosecond laser flap cutting. In order to get cuts parallel to the corneal surface, the cornea has to be forced into a defined shape and current femtosecond laser devices either use a flat or a curved patient interface design to achieve applanation. METHODS IOP was measured in enucleated eyeballs (n = 46) not suitable for keratoplasty by direct cannulation of the vitreous body. A second cannula was inserted to adjust IOP to a baseline pressure of 20 mm Hg. The eyeballs were lifted by custom made supporting stands to achieve an appropriate height and put under the femto-LASIK devices. RESULTS The flat patient interfaces gave rise to higher IOPs (IOP max = 328.3 ± 29.8, 228.8 ± 28.4, and 201.09 ± 21.4 mm Hg), whereas the curved patient interface caused lower IOPs in response to attachment and suction (IOP max = 104.9 ± 13.4 mm Hg). CONCLUSIONS Based on previous findings of visual field defects after LASIK, and as a consequence of the present study, it seems feasible to design patient interfaces in a more physiologic manner to prevent high IOPs during refractive procedures.