Five-year endothelial cell loss after implantation with artiflex myopia and artiflex toric phakic intraocular lenses

\u3cp\u3ePurpose: To evaluate the long-term changes in endothelial cell density (ECD) after the implantation of 2 types of foldable iris-fixated phakic intraocular lenses (pIOLs) for the treatment of myopia and astigmatism. Design: Prospective clinical cohort study. Methods: Two-hundred and ninety-three and 188 eyes implanted with, respectively, the Artiflex Myopia and Artiflex Toric (Ophtec B.V., Groningen, The Netherlands) iris-fixated pIOL for the treatment of myopia or astigmatism at the University Eye Clinic Maastricht as of January 2004. One-hundred and forty-six eyes from the myopic and 64 eyes from the toric groups completed a 5-year follow-up. Main outcome measures were chronic endothelial cell (EC) loss, percentage of eyes with a ≥25% decrease in ECD, and the percentage of eyes with an ECD < 1500 cells/mm\u3csup\u3e2\u3c/sup\u3e. Results: Chronic EC loss showed an annual decline of 64 cells/mm\u3csup\u3e2\u3c/sup\u3e in the myopic (P <.001, standard error 3.58) and 62 cells/mm\u3csup\u3e2\u3c/sup\u3e in the toric (P <.001, standard error 3.77) groups. Total chronic EC loss from 6 months to 5 years postoperatively was 10.5% in the myopic and 10.2% in the toric groups. After 5 years, an ECD decrease of ≥25% occurred in 4.4% and 4.3% of eyes, and an ECD < 1500 cells/mm\u3csup\u3e2\u3c/sup\u3e was reported in 3.0% and 0.0% of eyes, respectively. Explantation of a pIOL owing to EC loss was required in 3.1% and 0% of eyes. Conclusion: Chronic EC loss was around 10% over a 5-year period in eyes implanted with the foldable myopic (toric) pIOL. In up to 3.1% of eyes significant EC loss resulted in subsequent pIOL explantation.\u3c/p\u3

Long-term changes in visual outcomes and ocular morphometrics after myopic and toric phakic intraocular lens implantation:five- and 10-year results

\u3cp\u3ePurpose: To evaluate the long-term refractive and visual, anterior chamber depth, and axial length (AL) changes and complications after rigid iris-fixated phakic intraocular lens (pIOL) implantation to treat myopia or astigmatism. Setting: University Eye Clinic Maastricht, Maastricht UMC+, the Netherlands. Design: Prospective case series. Methods: The study evaluated patients who had implantation of an Artisan myopic or toric iris-fixated pIOL as of January 1998. Changes were measured annually and reported after 1, 5, and 10 years postoperatively. Results: The study comprised 460 eyes (250 patients; mean age 41.1 years ± 10.7 [SD]). Over 10 years, the mean myopization was −0.79 diopters (D) (P < .001), with 52% of eyes within ±1.0 D of target. The mean increase in the logarithm of the minimum angle of resolution (logMAR) corrected distance visual acuity (CDVA) over 10 years was 0.05 (P < .001); 95% of eyes had a CDVA of 20/40 or more and 7% lost 2 or more lines of CDVA. The mean logMAR uncorrected visual acuity (UDVA) increased by 0.14 over 10 years (P < .001); 96% had a UDVA 20/40 or better. The AL increased by 1.14 mm over 10 years (P = .009). Ten percent of pIOLs were explanted because of cataract formation after a mean of 97.9 ± 34.9 months. A higher preoperative age (hazard ratio [HR], 1.08; P < .001) and longer AL (HR, 1.34; P < .001) were risk factors for shorter survival because of cataract formation. Conclusion: Ten years after rigid iris-fixated pIOL implantation, the CDVA and UDVA decreased significantly as a result of significant myopization caused by an increased AL unrelated to the pIOL.\u3c/p\u3

Long-term endothelial cell loss in patients with artisan myopia and artisan toric phakic intraocular lenses 5- and 10-year results

\u3cp\u3ePurpose: To evaluate the long-term change in endothelial cell density (ECD) after the implantation of 2 types of rigid iris-fixated phakic intraocular lenses (pIOLs) for the treatment of myopia and astigmatism. Design: Prospective, clinical cohort study. Participants: A total of 507 eyes of 289 patients receiving the Artisan Myopia or Artisan Toric (Ophtec B.V., Groningen, The Netherlands) iris-fixated pIOL for the treatment of myopia or astigmatism at the University Eye Clinic Maastricht as of January 1998. Methods: A total of 381 myopic and 126 toric pIOLs were implanted. Five- and 10-year follow-ups were completed by 193 and 127 eyes implanted with the myopic pIOL and by 40 and 20 eyes implanted with the toric pIOL, respectively. Main Outcome Measures: Chronic endothelial cell (EC) loss, percentage of eyes with a decrease of ≥25% in ECD, and percentage of eyes with an ECD <1500 cells/mm \u3csup\u3e2\u3c/sup\u3e. Results: Chronic EC loss was calculated from 6 months postoperatively to the end of follow-up and showed an annual ECD decline of 48 cells/mm \u3csup\u3e2\u3c/sup\u3e (standard error, 3.14) and 61 cells/mm \u3csup\u3e2\u3c/sup\u3e (standard error, 6.30) in the myopic (P < 0.001) and toric (P < 0.001) groups, respectively, resulting in a total EC loss of 16.6% and 21.5% from 6 months to 10 years postoperatively, respectively. Ten years after implantation, ECD had decreased by ≥25% in 7.9% and 6.3%, whereas ECD was <1500 cells/mm \u3csup\u3e2\u3c/sup\u3e in 3.9% and 4.0% in the myopic and toric groups, respectively. Explantation of the pIOL occurred in 6.0% in the myopic group and 4.8% in the toric group. Risk factors for increased EC loss were a shallow anterior chamber depth (ACD) (P ≤ 0.005) and a smaller distance between the central and peripheral pIOL edge to the endothelium (P ≤ 0.005). Conclusions: A significant linear chronic EC loss was reported after implantation with myopic or toric iris-fixated pIOLs. A smaller ACD and smaller distance between pIOL edge and endothelium were risk factors for EC loss. Modification of preoperative age-related ECD thresholds is indicated to maintain an ECD that warrants safe future combined pIOL explantation and cataract surgery. \u3c/p\u3

First generation versus second generation toric calculator for toric IOL implantations

Purpose: To compare the accuracy of predicted postoperative residual refractive astigmatism after toric IOL implantation between a first generation and a second generation toric calculatorMethodA total of 458 eyes underwent cataract extraction and implantation of a toric IOL between 2011 and 2017. A first generation toric calculator (Acrysof Toric Calculator) was used in 323 eyes, whereas a second generation toric calculator (Barrett Toric Calculator) was used in 135 eyes. The primary outcome was to compare the amount of over‐ and undercorrection of pre‐existent astigmatism, using vector analysis.ResultsPreoperative both groups had comparable corneal astigmatism (respectively 2.43 ± 1.10 D and 2.31 ± 1.26 D for the Acrysof and Barrett group, p > 0.05). Postoperatively, no significant differences were seen in terms of misalignment, CDVA, residual refractive astigmatism, and spherical equivalent. A significant better uncorrected visual acuity was seen in the Barrett group compared to the Acrysof group (respectively 0.05 ± 0.12 vs 0.12 ± 0.17 logMar). Vector analyses showed a significantly lower percentage of overcorrection of ≥0.5 D or ≥1.0 D in the Barrett group (respectively 14% and 3%) compared to the Acrysof group (respectively 32% and 8%). A significant higher percentage of undercorrection of ≥0.5 D was seen in the Barrett group compared to the Acrysof group (respectively 7% and 2%). The correction index was significantly closer to the ideal 1.00 in the Barrett group (1.06 ± 0.24) compared to the Acrysof group (1.16 ± 0.24).ConclusionsThe use of a second generation toric calculator significantly reduces overcorrection after toric IOL implantation

Comparison of a trifocal intraocular lens with a+3.0 D bifocal IOL: results of a prospective randomized clinical trial

Purpose To compare visual outcomes in patients with cataract surgery and bilateral implantation of a trifocal or bifocal intraocular lens (IOL). Setting University Eye Clinic Maastricht, the Netherlands. Design Prospective randomized clinical trial. Methods Eyes with cataract and less than 1.0 diopter (D) of corneal astigmatism were randomized to receive bilateral implantation of Finevision Micro F trifocal IOLs or Acrysof IQ Restor +3.0 bifocal IOLs. Outcome measures were monocular and binocular uncorrected distance (UDVA), uncorrected intermediate (UIVA), and uncorrected near (UNVA) visual acuities; refractive outcomes; binocular defocus curve; contrast sensitivity; reading speed; patient satisfaction; and spectacle independence. Results Six months postoperatively, the mean binocular UDVA, UIVA, and UNVA in 56 eyes of 28 patients were 0.01 logMAR ± 0.11 (SD), 0.32 ± 0.15 logMAR, and 0.15 ± 0.13 logMAR in the trifocal group (n = 15) and 0.00 ± 0.09 logMAR, 0.28 ± 0.08 logMAR, and 0.12 ± 0.08 logMAR in the bifocal group (n = 13), respectively. The trifocal group showed a more continuous defocus curve and better results at −1.0 D of defocus (P < .01). The mean mesopic contrast sensitivity was higher in the bifocal group (P = .02). Complete spectacle independence was reported by 80% of trifocal patients and 50% of bifocal patients. There were no significant differences in refractive outcomes, reading speed, or patient satisfaction. Conclusion This study showed noninferiority of visual outcomes with the trifocal IOL compared with the bifocal IOL, although the defocus curve was better at an intermediate distance with the trifocal IOL. Financial Disclosure Dr. Bauer received study grants from Alcon Laboratories, Inc., Carl Zeiss Meditec AG, and Physiol S.A. and a lecture fee from Alcon Surgical, Inc. Dr. Nuijts is a consultant to Alcon Surgical, Inc., Théa Pharma GmbH, and ASICO LLC; he has received study grants from Acufocus, Inc., Alcon Surgical, Inc., Carl Zeiss Meditec AG, Ophtec BV, and Physiol S.A. No other author has a financial or proprietary interest in any material or method mentioned. Cataract is an age-related eye disease leading to an impairment of patients’ daily functioning as well as optical disturbances such as glare and halos.1 In 2010, an estimated 95 million people worldwide had cataracts.2 Surgical removal of the crystalline lens and replacement with an artificial intraocular lens (IOL) is the only vision-restoring option. After implantation of a monofocal IOL, reading glasses are usually needed for near vision, whereas multifocal IOLs result in better uncorrected near visual acuity (UNVA) with a reduced overall spectacle dependence.1, 3 and 4 Multifocal IOLs function by projecting multiple images on the retina, which may result in unwanted visual phenomena such as contrast reduction, glare, and halos.3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 Because most multifocal IOLs have only 2 foci, near and far, the quality of intermediate visual acuity might be insufficient for successful functioning in daily life.13 and 14 Trifocal IOLs have been developed to improve vision at intermediate distances.13 and 15 The goal of this randomized clinical trial was to compare the visual outcomes of a new trifocal IOL with those of a commonly used bifocal IOL. Patients and methods Patient Selection A randomized clinical study design was used to compare visual function and patient satisfaction after bilateral IOL implantation in patients treated for age-related cataract. Both patient enrollment and treatment took place at the University Eye Clinic Maastricht. Approval from the medical ethics committee was obtained, and all procedures were conducted according to the Declaration of Helsinki. Written informed consent was obtained from all patients. Inclusion criteria were bilateral cataract, less than 1.0 diopter (D) corneal astigmatism in both eyes, age over 42 years, and an expected postoperative corrected distance visual acuity (CDVA) of 0.3 logMAR or less. Exclusion criteria were combined ocular procedures, previous ocular surgery, ocular pathology that would limit postoperative visual outcome, suturing of the incision during surgery, and complications during surgery in the first eye. After enrollment, random allocation of study patients was performed to bilateral implantation of a trifocal IOL (trifocal group) or a bifocal IOL (bifocal group). Patients and investigators were masked. Surgical Technique Two experienced surgeons (N.B., R.N.) performed all surgical procedures, which consisted of a standard phacoemulsification technique through a 2.2 mm clear corneal incision. Surgery in the second eye was performed within 2 weeks of the first surgery in each patient. The same type of IOL was implanted in both eyes. The study used 2 types of IOLs: the Finevision Micro F trifocal IOL (Physiol S.A.) (Figure 1) and the Acrysof Restor IQ +3.0 D bifocal IOL (Alcon Surgical, Inc.) (Figure 2). The trifocal IOL is a foldable single-piece fully diffractive pupil-dependent aspheric IOL made of a hydrophilic acrylic with an ultraviolet (UV)- and blue-light inhibitor.13 and 15 It has an optic diameter of 6.15 mm, an overall diameter of 10.75 mm, and a 4-point haptic design for stability. It has +3.5 D additional power for near vision and +1.75 D additional power for intermediate vision, consists of 26 diffractive steps, and requires a minimum incision of 1.8 mm. The bifocal IOL is a foldable, single-piece, pupil-dependent aspheric biconvex IOL with a 3.6 mm center and 9 apodized diffractive steps.15 It is made of a hydrophobic acrylate/methacrylate copolymer with an UV-light and blue-light blocker. The optic diameter is 6.0 mm, and the overall diameter is 13.0 mm. It has +3.0 D additional power for near vision