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.

Refractive surgical correction of presbyopia with the AcuFocus small aperture corneal inlay: two-year follow-up.

PURPOSE: To evaluate the safety and efficacy of the AcuFocus Corneal Inlay 7000 (ACI 7000) implanted in emmetropic presbyopic patients for the improvement of near and intermediate vision over 2-year follow-up. METHODS: This prospective, non-randomized, non-comparative study included 32 naturally emmetropic presbyopic patients. The intracorneal inlay was implanted in the non-dominant eye over the pupil by creating a superior-hinged flap with the IntraLase 60-kHz femtosecond laser (Abbott Medical Optics). Inlay centration was over the line of sight. Minimum postoperative follow-up was 24 months. RESULTS: After mean follow-up of 24.2±0.8 months (range: 24 to 26 months), 96.9% of patients read J3 or better in the implanted eye. Mean binocular uncorrected near visual acuity improved from J6 preoperatively to J1 after 24 months. Mean binocular uncorrected intermediate visual acuity (UIVA) was 20/20 at 1 month and remained 20/20 throughout 24-month follow-up, with 71.9% of eyes reaching UIVA of 20/20 or better. At 24 months, mean uncorrected distance visual acuity was 20/20 in the implanted eye and 20/16 binocularly. No inlay was explanted during the study. Two decentered inlays were recentered after 6 months because of in-sufficient increase in near and intermediate visual acuity. Both patients' near and intermediate visual acuity improved significantly after recentration. CONCLUSIONS: The ACI 7000 seems to provide a safe and effective treatment for presbyopia over follow-up of 2 years.

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.

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.

Rotational stability and visual outcome after implantation of a new toric intraocular lens for the correction of corneal astigmatism during cataract surgery.

PURPOSE: To evaluate rotational stability and the refractive and visual outcomes of a new aspheric toric intraocular lens (IOL) for correction of preexisting corneal astigmatism during routine cataract surgery. SETTING: Department of Ophthalmology, Paracelsus Medical University Salzburg, Salzburg, Austria. DESIGN: Case series. METHODS: Aspheric Bi-Flex T toric IOLs were monolaterally or bilaterally implanted after phacoemulsification in patients with topographic corneal astigmatism between 1.5 diopters (D) and 4.0 D. Preoperative IOL calculations were performed by laser interference biometry (Haigis formula). Appropriate IOL-torus alignment was facilitated by combined imaging and eye-tracking technology. Refraction and uncorrected distance (UDVA) and corrected distance visual acuities were measured 1 day, 1 week, and 1 and 3 months postoperatively. At each visit, photodocumentation in retroillumination was performed to evaluate torus position and potential toric IOL rotation. RESULTS: The mean refractive astigmatism decreased from 1.93 D ± 0.90 (SD) (range 0.5 to 4.0 D) to 0.30 ± 0.54 D (range 0.0 to 1.5 D) at 3 months. Patients achieved a mean UDVA of 0.05 ± 0.12 logMAR (range -0.18 to 0.30 logMAR [∼20/20]). Intraoperative to 3-month postoperative comparison of IOL axis alignment showed low levels of rotation (mean 2.12 ± 3.45 degrees; range -2 to +5 degrees). CONCLUSIONS: Implantation of the new aspheric toric IOL was effective, safe, and stable in correcting preexisting regular corneal astigmatism during cataract surgery. Combined imaging and eye tracking seems to be a promising technology to evaluate the correct axis for IOL torus alignment.

Femtosecond laser-assisted intrastromal arcuate keratotomy to reduce corneal astigmatism.

PURPOSE: To report the initial results of intrastromal arcuate keratotomy performed with a femtosecond laser to treat corneal astigmatism. SETTING: Department of Ophthalmology, Paracelsus Medical University, Salzburg, Austria. DESIGN: Interventional case series. METHODS: Patients with corneal astigmatism (naturally occurring or after cataract surgery) were treated with an iFS femtosecond laser to perform paired arcuate cuts on the steep axis completely placed within the corneal stroma. Patients were followed for 6 months after surgery. Preoperative and postoperative (1-day, 1-week, and 1-, 3-, and 6-month) examinations included corrected and uncorrected visual acuities, manifest refraction, corneal topography, endothelial cell count, and corneal pachymetry. A subjective questionnaire was used to evaluate patient satisfaction. RESULTS: The study enrolled 16 patients. No perforations occurred, and all incisions were placed at the planned locations. After a 6-month follow-up, the mean refractive cylinder was reduced significantly from 1.41 diopters (D) ± 0.66 (SD) to 0.33 ± 0.42 D (P<.001). The mean topographic astigmatism was reduced significantly from 1.50 ± 0.47 D preoperatively to 0.63 ± 0.34 D at 6 months (P=.002). There was excellent refractive and topographic stability over time. The endothelial cell density was unchanged. Patient satisfaction was very high. CONCLUSION: The femtosecond laser allowed the effective creation of precise, purely intrastromal, arcuate incision patterns with an excellent safety profile, rapid recovery, and stability of vision without the known risks associated with incisions that penetrate Bowman membrane.

Reading performance after implantation of a modified corneal inlay design for the surgical correction of presbyopia: 1-year follow-up.

PURPOSE: To evaluate change in different reading performance parameters after monocular ACI7000PDT corneal inlay implantation for the improvement of near and intermediate vision. DESIGN: Prospective, interventional case series. METHODS: Twenty-four patients were scheduled for corneal inlay implantation in the nondominant eye in a university outpatient surgery center. Naturally emmetropic and presbyopic patients between 45 and 60 years of age, with uncorrected distance visual acuity of at least 20/20 in both eyes, without any additional ocular pathology were eligible for inclusion. Bilateral uncorrected reading acuity, mean and maximum reading speed, and smallest log-scaled print size were evaluated with the standardized Radner Reading Charts. Measurements of reading parameters and reading distance were performed with the Salzburg Reading Desk (SRD). Minimum postoperative follow-up was 12 months. RESULTS: The reading desk results showed significant changes in each parameter tested. After 12 months the mean reading distance changed from the preoperative value of 46.7 cm (95% CI: 44.1-49.3) to 42.8 cm (95% CI: 40.3-45.3, P < .004), and the mean reading acuity "at best distance" improved from 0.33 logRAD (95% CI: 0.27-0.39) to 0.24 logRAD (95% CI: 0.20-0.28, P < .005). Mean reading speed increased from 141 words per minute (wpm, 95% CI: 133-150) to 156 wpm (95% CI: 145-167, P < .003), maximum reading speed increased from 171 wpm (95% CI: 159-183) to 196 wpm (95% CI: 180-212, P = .001), and the smallest print size improved from 1.50 mm (95% CI: 1.32-1.67) to 1.12 mm (95% CI: 1.03-1.22, P < .001). CONCLUSIONS: After ACI7000PDT implantation, there were significant changes in all tested reading performance parameters in emmetropic presbyopic patients. These 1-year results indicate that the inlay seems to be an effective treatment for presbyopia.

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.

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.

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.

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.

Complement factor H Y402H gene polymorphism and response to intravitreal bevacizumab in exudative age-related macular degeneration.

PURPOSE: To determine whether different complement factor H (CFH) genotypes play a role in treatment of age-related macular degeneration (AMD) with intravitreal bevacizumab. METHODS: In this prospective study, we included 197 patients with exudative AMD and treated with 1.25 mg intravitreal bevacizumab at 6-week intervals until choroidal neovascularization (CNV) was no longer active. In all patients, ophthalmological examinations, visual acuity, optical coherence tomography (OCT), fundus photography and fluorescein angiography were performed. Single nucleotide polymorphism (SNP) genotyping was performed using restriction fragment length polymorphism (RFLP) analysis of polymerase chain reaction (PCR) products. RESULTS: Age, gender and baseline mean visual acuity were similar among the three CFH genotypes. There was no significant difference in underlying lesion type of CNV, lesion size, number of injections or macula thickness. When examining the effect of genotype on post-treatment visual acuities, we observed a significant worse outcome for distance and reading visual acuity in the CFH 402HH genotype group. The number of patients who lost 3 or more lines in distance and reading visual acuity testing was significantly higher in the CFH 402HH (41%, 46%) genotype group than in patients with the CFH 402YY (28%, 26%) and CFH 402YH (26%, 24%) genotype. CONCLUSIONS: In addition to the higher risk for exudative AMD in patients with the CFH 402HH genotype that was found in previous studies, our results show that the CFH 402HH genotype also correlates with lower visual acuity outcome after treatment with bevacizumab, suggesting that pharmacogenetics of CFH plays a role in response to treatment of wet AMD.

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.