Vector Analysis, Rotational Stability, and Visual Outcome After Implantation of a New Aspheric Toric IOL.

PURPOSE: To evaluate vector analysis, rotational stability, and refractive and visual outcome of a new toric intraocular lens (IOL) for correction of preexisting corneal astigmatism during routine cataract surgery. METHODS: In this prospective, interventional case series, 30 toric, aspheric Bi-Flex T toric IOLs (Medicontur Medical Engineering Ltd., Inc., Zsámbék, Hungary) were implanted in 20 consecutive patients with topographic corneal astigmatism between 1.50 and 4.00 diopters (D) and evaluated within the first year after implantation. Appropriate IOL-toric alignment was facilitated by combined imaging/eye tracking technology. Postoperative evaluation included refraction and uncorrected and corrected distance visual acuities (UDVA, CDVA). For each visit, photodocumentation in retroillumination was performed to evaluate toric alignment and potential toric IOL rotation. Vector analysis of refractive astigmatism was performed using the Alpins method. RESULTS: At 12 months postoperatively, a reduction of the refractive astigmatism from 1.93±0.90 D (range: 0.50 to 4.00 D) to 0.28±0.61 D (range: 0.00 to 1.50 D) could be found, with patients achieving a mean UDVA of 0.06±0.16 logMAR (range: -0.18 to 0.40 logMAR; Snellen 20/20). Intraoperative to 12-month postoperative comparison of IOL axis alignment showed low levels of rotation (0.2°±2.41°; range: +4° to -5°). Vector analysis showed target induced astigmatism of 0.60 D @180°, surgically induced astigmatism of 0.80 D @177°, correction index of 1.02±0.25, and a difference vector of 0.30 D @82°. CONCLUSIONS: Implantation of the new Bi-Flex T IOL was a safe, stable, and effective method to correct preexisting regular corneal astigmatism during cataract surgery.

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.

Randomized controlled clinical trial to evaluate different intraocular lenses for the surgical compensation of low to moderate-to-high regular corneal astigmatism during cataract surgery.

PURPOSE: To evaluate vector analysis, rotational stability, and visual outcomes after implantation of toric IOLs with low (<2.25 diopter [D]) toric values (Acrysof IQ SN6AT3 or SN6AT4) and moderate-to-high toric (3.00 D to 6.00 D) values (Acrysof IQ SN6AT5, SN6AT6, SN6AT7, SN6AT8, or SN6AT9) versus after implantation of a nontoric IOL (Acrysof SN60WF) in eyes with regular topographic corneal astigmatism. SETTING: Department of Ophthalmology, Paracelsus Medical University Salzburg, Salzburg, Austria. DESIGN: Randomized controlled clinical trial. METHODS: The study included eyes of patients undergoing phacoemulsification and IOL implantation. Patients were randomized into 3 groups to bilaterally receive the nontoric IOL, the low toric IOL, or the moderate-to-high toric IOL. Over a 6-week follow-up period, rotational stability and astigmatic changes were evaluated in the 2 toric IOL groups using the Alpins vector method. RESULTS: The study included 78 eyes of 39 patients. Postoperatively mean refractive astigmatism decreased significantly from 1.45 D ± 1.18 (SD) to 0.36 ± 0.44 D in the low toric group and from 1.92 ± 1.09 D to 0.31 ± 0.46 D in the moderate-to-high toric group. There was no significant difference between mean difference vectors in the low toric IOL group and the moderate-to-high toric IOL group. A significant difference in the correction index was detected, revealing overcorrection with low toric IOLs (1.03 ± 0.12 D) and undercorrection with moderate-to-high toric IOLs (0.95 ± 0.12 D). CONCLUSIONS: Implantation of low toric IOLs and medium-to-high toric IOLs in patients with low to moderate-to-high corneal astigmatism was shown to be effective in correcting regular corneal astigmatism. Undercorrection in the moderate-to-high group could be related to misalignment. FINANCIAL DISCLOSURE: This research project was financially supported by the Fuchs Foundation for the Promotion of Research in Ophthalmology, Salzburg, Austria. Alcon Inc. financially supports the Fuchs-Foundation as the clinical research center of the Department of Ophthalmology of the Paracelsus Medical University Salzburg, Salzburg, Austria (Grant Number 2010-37). No author has a financial or proprietary interest in any material or method mentioned.

Intraindividual aqueous flare comparison after implantation of hydrophobic intraocular lenses with or without a heparin-coated surface.

PURPOSE: To assess the efficacy of a heparin-surface-modified (HSM) hydrophobic acrylic intraocular lens (IOL) (EC-1YH PAL) and the same IOL without heparin coating (EC-1Y-PAL) by the flare and cell intensity in the anterior chamber after uneventful cataract surgery. SETTING: Department of Ophthalmology, Paracelsus Medical University Salzburg, Austria. DESIGN: Comparative case series. METHODS: Routine phacoemulsification with randomized implantation of an HSM IOL in 1 eye (HSM IOL group) and an uncoated IOL (uncoated IOL group) in the fellow eye was performed. Postoperative inflammation was assessed objectively using a laser flare-cell meter (FM-600) preoperatively as well as 1 day and 1 and 3 months postoperatively. Aqueous cells in the anterior chamber, distance visual acuities, and subjective manifest refraction were also evaluated at each visit. RESULTS: One hundred eyes (50 patients) were enrolled. In both groups, the mean flare values increased significantly from preoperatively to 1 day postoperatively (P<.001) and nearly reached preoperative values by 3 months postoperatively. One day postoperatively, the mean flare value was statistically significantly lower in the HSM IOL group (14.92 photons per millisecond [ph/ms] ± 7.47 [SD]) than in the uncoated IOL group (mean 16.73 ± 7.81 ph/ms) (P=.04); there was no statistically significant difference between groups 1 and 3 months postoperatively (both P>.58). The HSM IOL group had a greater and quicker decrease in aqueous cells, reaching statistical significance 1 month postoperatively (P=.01). CONCLUSION: The HSM IOL showed a significant lower inflammatory reaction in the early postoperative stage with a faster disappearance of inflammatory signs. FINANCIAL DISCLOSURE: No 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.

Role of rs1533428 and rs12994401 in patients with Primary Open Angle Glaucoma in an European population.

PURPOSE: Genetic factors have been shown to play a remarkable role in the pathophysiology of glaucoma. Recently, two polymorphisms (rs1533428 and rs12994401) on chromosome 2p were found to be strongly associated with POAG in an Afro-Caribbean population in Barbados, West Indies. As data with regard to the role of these polymorphisms in a Caucasian population are lacking, the present study was set to investigate a hypothetical association between these polymorphisms and POAG in a Caucasian population. METHODS: In total 723 participants were included in this study comprising 366 patients with POAG and 357 control subjects from the southern part of Austria. Genotyping of rs1533428 and rs12994401 was performed using polymerase chain reaction. RESULTS: Allelic frequencies and genotype distributions of rs1533428 and rs12994401 did not show statistical significance between patients with POAG and control subjects (p < 0.05). Presence of the rs1533428 T-allele was associated with an odds ratio of 0.95 (95% CI: 0.76-1.19; p = 0.69) for POAG, while the rs12994401 T-allele was associated with an odds ratio of 0.94 (95% CI: 0.73-1.21; p = 0.65) for POAG. CONCLUSION: Our data suggest that rs1533428 and rs12994401 themselves are unlikely major risk factors for POAG in a Central European population.

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.

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.

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.