Disease-specific assessment of Vision Impairment in Low Luminance in age-related macular degeneration - a MACUSTAR study report.

BACKGROUND/AIMS: To further validate the Vision Impairment in Low Luminance (VILL) questionnaire, which captures visual functioning and vision-related quality of life (VRQoL) under low luminance, low-contrast conditions relevant to age-related macular degeneration (AMD). METHODS: The VILL was translated from German into English (UK), Danish, Dutch, French, Italian and Portuguese. Rasch analysis was used to assess psychometric characteristics of 716 participants (65% female, mean age 72±7 years, 82% intermediate AMD) from the baseline visit of the MACUSTAR study. In a subset of participants (n=301), test-retest reliability (intraclass correlation coefficient (ICC) and coefficient of repeatability (CoR)) and construct validity were assessed. RESULTS: Four items were removed from the VILL with 37 items due to misfit. The resulting Vision Impairment in Low Luminance with 33 items (VILL-33) has three subscales with no disordered thresholds and no misfitting items. No differential item functioning and no multidimensionality were observed. Person reliability and person separation index were 0.91 and 3.27 for the Vision Impairment in Low Luminance Reading Subscale (VILL-R), 0.87 and 2.58 for the Vision Impairment in Low Luminance Mobility Subscale (VILL-M), and 0.78 and 1.90 for the Vision Impairment in Low Luminance Emotional Subscale (VILL-E). ICC and CoR were 0.92 and 1.9 for VILL-R, 0.93 and 1.8 for VILL-M and 0.82 and 5.0 for VILL-E. Reported VRQoL decreased with advanced AMD stage (p<0.0001) and was lower in the intermediate AMD group than in the no AMD group (p≤0.0053). CONCLUSION: The VILL is a psychometrically sound patient-reported outcome instrument, and the results further support its reliability and validity across all AMD stages. We recommend the shortened version of the questionnaire with three subscales (VILL-33) for future use. TRIAL REGISTRATION NUMBER: NCT03349801.

Multicenter Evaluation of Time, Operational, and Economic Efficiencies of a New Preloaded Intraocular Lens Delivery System versus Manual Intraocular Lens Delivery.

PURPOSE: To evaluate intraoperative intraocular lens (IOL) delivery time and total surgical case time using the UltraSert preloaded delivery system (System U) during routine cataract surgeries and to compare with the manually loaded Monarch delivery system (System M). Physician satisfaction with System U was also assessed. PATIENTS AND METHODS: In this prospective observational study, subjects ≥18 years old underwent cataract surgery in 1 eye and received the AcrySof IQ IOL via the manually loaded System M (n=103) or the AcrySof IQ IOL model AU00T0 via the preloaded System U (n=93). Procedures were digitally recorded by an external camera or by a camera within the operating microscope. Device preparation, IOL delivery, and IOL positioning times were evaluated by 2 independent graders. Pearson χ2 test or Fisher exact test was used for categorical variables and Student's t-test or Wilcoxon rank-sum test for continuous variables (all tests were 2-sided and performed at a 5% α-level). Physician satisfaction levels were assessed using questionnaires. RESULTS: Lens delivery time was similar for System U and System M (12.9±5.1 and 12.2±6.3 s; P=0.412). Mean device preparation time for System U was significantly shorter compared with System M (30.3±6.6 versus 59.8±31.0 s; P<0.05). This resulted in a significantly shorter total intraoperative time (device preparation + lens delivery) with System U versus System M (43.0±8.6 versus 72.0±32.5 s; P<0.05). Total surgical case time (device preparation + lens delivery + lens positioning and unfolding) was shorter for System U versus System M (56.6±12.6 versus 89.6±34.6 s; P<0.05). Physicians reported greater satisfaction levels with System U compared with other devices. CONCLUSION: Use of the preloaded delivery system (System U) resulted in faster device preparation and reduced total surgical time compared with the manually loaded system (System M). System U was intuitive to use, and physicians preferred it to other devices.

Comparing the long-term impact on health care resources utilization and costs due to various single-piece acrylic monofocal intraocular lens implantation during cataract surgery: a cost-consequence analysis for the United Kingdom, Italy, and Denmark.

PURPOSE: The objective of this study was to estimate the cost impact of neodymium-doped yttrium aluminum garnet (Nd:YAG) laser capsulotomy and its complications due to single-piece acrylic monofocal intraocular lenses (IOLs) in the healthcare setting of United Kingdom, Italy, and Denmark. MATERIALS AND METHODS: A hypothetical cost-consequence model was developed to estimate economic burden of Nd:YAG laser capsulotomy due to different single-piece acrylic monofocal IOLs. Cumulative incidence of Nd:YAG laser capsulotomy at 3 years after cataract surgery with five single-piece monofocal acrylic IOLs was sourced from retrospective data analysis of electronic medical records of cataract patients in the United Kingdom. Risk probability of post-Nd:YAG laser complications, ie, retinal detachment, glaucoma, and cystoid macular edema at 3 years was derived using published literature. Unit costs were taken from publicly available sources with all costs converted to euro (€). Number of cataract procedures per year for each country was sourced from Eurostat statistics. RESULTS: For the estimated cataract procedures carried out nationally every year, single-piece monofocal hydrophobic AcrySof IOL was associated with substantially lower cases of Nd:YAG laser capsulotomy procedures and subsequent complications in 3 years after cataract surgery when compared to other single-piece monofocal acrylic IOLs. The total cost savings with the use of AcrySof over other IOLs in countries assessed ranged from €0.5 to €4.7 million (vs AMO Tecnis) and €2.1 to €17.9 million (vs Rayner C-/Super-flex). CONCLUSION: Incidence of Nd:YAG capsulotomy due to the choice of IOL could significantly affect healthcare budgets in the post-cataract surgery period. Our analysis indicates that single-piece monofocal AcrySof IOLs is the most cost-saving treatment option for health care systems when compared to other acrylic single-piece IOLs.

Global prevalence and economic and humanistic burden of astigmatism in cataract patients: a systematic literature review.

PURPOSE: To systematically review the published evidence on the prevalence and economic and humanistic burden of astigmatism in cataract patients. MATERIALS AND METHODS: For this systematic literature review, the Medline, PubMed, Embase, and Cochrane databases were searched from 1996 to September 2015 for available scientific literature that met the inclusion criteria. Studies published in the English language reporting prevalence and humanistic and economic burden in patients diagnosed with cataract and astigmatism were included. RESULTS: Of 3,649 papers reviewed, 31 studies from 32 publications met the inclusion criteria of this review. Preexisting astigmatism ≥1 D was present in up to 47% of cataract eyes. The cost burden of residual uncorrected astigmatism after cataract surgery was driven by the cost of spectacles, which was estimated to range from $2,151 to $3,440 in the US and $1,786 to $4,629 in Europe over a lifetime. In cataract patients, both preexisting and postoperative residual astigmatism were associated with poor vision-related patient satisfaction and quality of life, as well as higher spectacle burden. Astigmatism correction during cataract surgery appears to improve visual outcomes and results in overall lifetime cost savings compared to astigmatism correction with postoperative vision correction. CONCLUSION: There is a high prevalence of preexisting astigmatism in cataract patients. Although published data are limited, both preoperative astigmatism and postoperative residual astigmatism affect visual function and vision-related quality of life, resulting in increased humanistic burden. Suboptimal correction of astigmatism during cataract surgery drives the continuous need for vision correction with spectacles in the postoperative period. Patients must bear the out-of-pocket expenses, since payers often do not reimburse the cost of spectacles. Greater access to astigmatism correction during cataract surgery could improve visual outcomes and quality of life in patients. More research is required to gain a better understanding of the disease burden of astigmatism in cataract patients.