Changes in visual outcomes and ocular morphometrics after foldable myopic and toric intraocular lens implantation: 5-year results.

PURPOSE: To evaluate the refractive, visual, and morphometric changes after implantation with a foldable iris-fixated phakic intraocular lens (pIOL) to correct myopia or astigmatism. SETTING: University Eye Clinic Maastricht, the Netherlands. DESIGN: Prospective case series. METHODS: We evaluated patients implanted with the Artiflex Myopia Toric (Ophtec B.V.) iris-fixated pIOL as of January 2004. Measurements were performed annually and reported after 1 and 5 years. RESULTS: The study included 481 eyes (277 patients; age 39.8 ± 10.9 years [SD]). 5 years postoperatively, 91% of eyes were within ±1.0 diopter (D) of target, and the mean myopization over a 5-year period was 0.22 D (P < .001). The logMAR corrected distance visual acuity (CDVA) increased by a mean 0.015 (P = .015) over 5 years; 88% of eyes had a CDVA of 20/20 or better, and 5.5% lost 2 or more lines of CDVA. Mean uncorrected distance visual acuity (UDVA) increased by 0.045 logMAR over 5 years (P < .001); 96% reached an UDVA of 20/40 or more. Anterior chamber depth (ACD) decreased by 0.04 mm (P < .001), and axial length (AL) increased by 0.23 mm (P < .001) over 5 years. Chronic endothelial cell loss showed a 5-year decline of 320 cells/mm2 in the myopic and 310 cells/mm2 in the toric subgroups (P < .001). Cataract resulted in pIOL explantation in 4.0% of eyes (mean survival 59.0 ± 40.0 months); higher preoperative age (hazard ratio [HR], 1.13; P < .001) and smaller ACD (HR, 6.80; P = .035) were risk factors for shorter survival due to cataract formation. CONCLUSIONS: Over 5 years, logMAR CDVA and UDVA decreased significantly due to myopization caused by lenticular changes and AL elongation.

Bilateral Implantation of a New Refractive Multi-Segmented Multifocal Intraocular Lens in Cataract or Refractive Lens Exchange Patients.

PURPOSE: To evaluate the safety and efficacy of a new multi-segmented refractive multifocal intraocular lens (IOL) after phacoemulsification and refractive lens exchange (RLE). PATIENTS AND METHODS: In this prospective, multicenter clinical trial, 63 presbyopic subjects who had cataract or where RLE candidates were bilaterally implanted with the Precizon Presbyopia IOL (Ophtec BV, Groningen, the Netherlands) after phacoemulsification. The study was conducted at 6 clinical centers in Germany, the Netherlands, Belgium, Turkey and Spain. Subjects were evaluated at baseline and at 1 day, 1 week, 1 and 3 months postoperatively for monocular and binocular uncorrected (UDVA) and corrected distance visual acuity (CDVA), uncorrected (UIVA) and distance-corrected intermediate visual acuity (DCIVA), uncorrected (UNVA), corrected (CNVA) and distance-corrected near visual acuity (DCNVA), contrast sensitivity and quality of vision. RESULTS: Three months postoperatively, binocular UDVA and CDVA of ≥20/40 was achieved in 98.4% (60/61) and 100%, respectively. Binocular UIVA and DCIVA of ≥20/40 was achieved in 96.7% (59/61) and 93.4% (57/61) respectively. Binocular UNVA, CNVA and DCNVA of ≥20/40 was achieved in 93.4% (57/61), 98.4% (60/61) and 95% (57/60) subjects, respectively. Complete spectacle independence was achieved in 80% (49/61) patients; 93% of patients reported that they were quite or very satisfied with the outcomes of the procedure. CONCLUSION: Precizon Presbyopia IOL implantation is a safe and effective method to provide good visual acuity at all distances in presbyopic and cataract patients.

Phakic intraocular lenses: An overview.

Phakic intraocular lenses (pIOLs) are a common solution for the surgical correction of high myopia and myopia in thin corneas. Global trends result in increasing rates of patients with high myopia which will result in increased rates of pIOL implantation. Three types of lenses can be distinguished: anterior chamber angle-supported, anterior chamber iris-fixated, and posterior chamber phakic IOLs. The efficacy of phakic intraocular lenses is generally very good, but pIOLs have undergone many changes over the years to improve the safety profile and decrease pIOL-related complications such as endothelial cell loss, corneal decompensation and cataract formation. This article describes the efficacy and safety profiles of the most recent pIOLs, as well as suggests gaps of knowledge that are deserve additional research to optimize the results of pIOLs.

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

PURPOSE: 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.

Risk factors for explantation of iris-fixated phakic intraocular lenses.

PURPOSE: To determine risk factors for explantation of iris-fixated phakic intraocular lenses (pIOLs) with a maximum 17-year follow-up. SETTING: University Eye Clinic Maastricht, Maastricht UMC+, the Netherlands. DESIGN: Prospective case series. METHODS: Eyes that had implantation of 1 of various iris-fixated pIOL models from 1998 to 2016 were evaluated. Primary outcome measures were the rate and proportion of pIOL explantations and the survival time (ie, time to pIOL explantation) in general and specifically as a result of cataract formation or endothelial cell loss (ECL). RESULTS: The study comprised 1037 eyes. The mean follow-up was 69.3 months ± 52.8 (SD) and the mean preoperative age, 40.2 ± 10.9 years. The overall explantation rate was 12% after a mean of 166.1 months ± 3.0 (standard error). Phakic IOL explantations were performed in 59% of eyes because of cataract formation and in 32% because of ECL. Shorter survival was seen with a higher preoperative age (hazard ratio [HR], 1.07/y; P < .001), longer axial length (AL) (HR, 1.10/mm; P = .009), and smaller anterior chamber depth (ACD) (HR, 4.47/mm; P < .001). Factors for shorter survival resulting from cataract were older preoperative age, longer AL, and larger ACD. Risk factors contributing to shorter survival resulting from ECL were a smaller ACD, lower endothelial cell density, and implantation with an Artisan hyperopia (toric) or Artiflex myopia (toric) IOL. CONCLUSIONS: The explantation rate of iris-fixated pIOLs was 12% after almost 14 years of follow-up, with 59% of pIOL explantations caused by cataract formation and 32% caused by ECL. An older preoperative age, longer AL, and smaller ACD were risk factors for a shorter survival.

Validity and time course of surgical fear as measured with the Surgical Fear Questionnaire in patients undergoing cataract surgery.

OBJECTIVES: The primary aim of the study was to assess the convergent validity of the Surgical Fear Questionnaire (SFQ) with other self-report instruments and biological indices of stress. Secondary aims were the examination of predictors of the level and time course of fear and preferences for fear treatment. METHODS: In a prospective observational cohort study SFQ short-term (SFQ-s) and long-term (SFQ-l) scores were assessed one week, one day, and the morning before cataract surgery, together with salivary cortisol and alpha-amylase (sAA) levels, and numeric rating scale (NRS) fear score. SFQ-scores were also assessed before second eye surgery. Expected pain and recovery, and sociodemographic and medico-psychological predictors of fear were assessed at baseline. RESULTS: Data of 98 patients were analyzed. Scores of both SFQ-subscales (range 0-40) were generally low, all mean ≤ 9.0. SFQ-s and SFQ-l correlated significantly with the other self-report instruments: NRS fear .83 and .89, expected pain .49 and .54, expected recovery -.27 and -.44. No association was found between SFQ-scores and cortisol or sAA level. Predictors of the level of fear were baseline pain and stress. Additional effects of time were found for subgroups based on educational level, antidepressant use, and presurgical stress (SFQ-l). SFQ-scores were significantly lower before the second cataract surgery than before the first, and higher in patients who would have appreciated treatment of fear. DISCUSSION: Convergent validity of the SFQ with other self-report measures is shown. The sensitivity of the SFQ permits the detection of small variations in fear caused by time or other factors.

Five-Year Endothelial Cell Loss After Implantation With Artiflex Myopia and Artiflex Toric Phakic Intraocular Lenses.

PURPOSE: 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/mm2. RESULTS: Chronic EC loss showed an annual decline of 64 cells/mm2 in the myopic (P < .001, standard error 3.58) and 62 cells/mm2 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/mm2 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.

Long-Term Endothelial Cell Loss in Patients with Artisan Myopia and Artisan Toric Phakic Intraocular Lenses: 5- and 10-Year Results.

PURPOSE: 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/mm2. 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/mm2 (standard error, 3.14) and 61 cells/mm2 (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/mm2 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.

Bilateral implantation of +2.5 D multifocal intraocular lens and contralateral implantation of +2.5 D and +3.0 D multifocal intraocular lenses: Clinical outcomes.

PURPOSE: To assess the clinical visual outcomes of bilateral implantation of Restor +2.5 diopter (D) multifocal intraocular lenses (IOLs) and contralateral implantation of a Restor +2.5 D multifocal IOL in the dominant eye and Restor +3.0 D multifocal IOL in the fellow eye. SETTING: Multicenter study at 8 investigative sites. DESIGN: Prospective randomized parallel-group patient-masked 2-arm study. METHODS: This study comprised adults requiring bilateral cataract extraction followed by multifocal IOL implantation. The primary endpoint was corrected intermediate visual acuity (CIVA) at 60 cm, and the secondary endpoint was corrected near visual acuity (CNVA) at 40 cm. Both endpoints were measured 3 months after implantation with a noninferiority margin of Δ = 0.1 logMAR. RESULTS: In total, 103 patients completed the study (53 bilateral, 50 contralateral). At 3 months, the mean CIVA at 60 cm was 0.13 logMAR and 0.10 logMAR in the bilateral group and contralateral group, respectively (difference 0.04 logMAR), achieving noninferiority. Noninferiority was not attained for CNVA at 40 cm; mean values at 3 months for bilateral and contralateral implantation were 0.26 logMAR and 0.11 logMAR, respectively (difference 0.15 logMAR). Binocular defocus curves suggested similar performance in distance vision between the 2 groups. Treatment-emergent ocular adverse events rates were similar between the groups. CONCLUSION: Bilateral implantation of the +2.5 D multifocal IOL resulted in similar distance as contralateral implantation of the +2.5 D multifocal IOL and +3.0 D multifocal IOL for intermediate vision (60 cm), while noninferiority was not achieved for near distances (40 cm).

Phakic intraocular lens: Two-year results and comparison of endothelial cell loss with iris-fixated intraocular lenses.

PURPOSE: To evaluate the efficacy, safety, and stability of a foldable angle-supported Acrysof Cachet phakic intraocular lens (pIOL) to correct moderate to high myopia and compare endothelial cell loss after iris-fixated Artisan and Artiflex pIOL implantation. SETTING: University Eye Clinic Maastricht, the Netherlands. DESIGN: Retrospective observational study. METHODS: Foldable angle-supported pIOL implantation for myopia ranging from -6.0 to -16.5 diopters (D) was done. Uncorrected (UDVA) and corrected (CDVA) distance visual acuity, spherical equivalent (SE), and adverse events were documented preoperatively and 6 months and 1 and 2 years postoperatively. Endothelial cell loss after implantation of the foldable angle-supported pIOL and iris-fixated pIOLs was compared 6 months and 1 and 2 years postoperatively. RESULTS: There were 158 eyes. The UDVA was equal to or more than 20/25 in 95% of eyes at 1 and 2 years postoperatively. The mean SE was -0.17 D ± 0.43 (SD) 2 years postoperatively. One patient developed pupil ovalization, resulting in explantation of the pIOL from both eyes. Acute endothelial cell loss in the foldable angle-supported pIOL group was -3.2% ± 0.7%, significantly higher than after iris-fixated pIOL implantation. Chronic endothelial cell loss from 6 to 24 months after surgery was -3.8% ± 0.7%. At the 2-year follow-up, the chronic endothelial cell loss in the foldable angle-supported pIOL group was not different than with iris-fixated pIOLs (P > .05). CONCLUSIONS: The foldable angle-supported pIOL effectively corrected moderate to high myopia. However, acute surgical endothelial cell loss was significantly higher than with iris-fixated pIOLs. FINANCIAL DISCLOSURE: Dr. Nuijts is a consultant to Alcon Laboratories, Inc., Théa Pharma GmbH, and ASICO LLC; he has received study grants from Acufocus, Inc., Alcon Laboratories, 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.

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.