Qualitative Exploration of the Visual Function Impairments and Health-Related Quality of Life Impacts of Amblyopia in Adult and Pediatric Populations.

INTRODUCTION: Amblyopia is a reduction in vision in one or both eyes due to impaired development of the visual pathway. This study explored the experience of amblyopia and treatment from the patient, caregiver, and clinician perspectives. METHODS: A targeted literature review, including a review of social media listening (SML) studies, was conducted. Next, qualitative interviews were conducted with amblyopia patients, caregivers of children with amblyopia, and ophthalmologists with experience treating patients with amblyopia. The findings informed the development of a disease model. Amblyopia clinical experts provided input at key stages. RESULTS: Twelve data sources were reviewed, including qualitative studies in the literature and SML studies. Overall, 133 patients/caregivers were interviewed (23 adults, 16 adolescents, 47 child-caregiver dyads), plus 10 ophthalmologists from the United States, France, and Germany. Reduced visual acuity, impaired depth perception, impaired peripheral vision, and double vision were the most frequently reported symptoms. Amblyopia impacted daily activities (reading, using digital devices), the ability to move around, school/work (productivity, seeing the board in class), emotional well-being (frustration, sadness), and social functioning (difficulty socializing). Treatments, including patching and corrective lens, also impacted daily activities (using digital devices, sports/leisure), mobility (bumping into things), and work/school (tasks taking longer) as well as emotional well-being (embarrassment), and social functioning (bullying/stigma). CONCLUSION: The findings contribute valuable insights into the adult and pediatric experience of amblyopia from a multi-stakeholder perspective. The findings were used to critically assess existing clinical outcome assessments and supported the development of patient- and observer-reported outcome measures for use in amblyopia clinical trials.

Psychometric Validation of the ViSIO-PRO and ViSIO-ObsRO in Retinitis Pigmentosa and Leber Congenital Amaurosis.

INTRODUCTION: Retinitis Pigmentosa (RP) and Leber Congenital Amaurosis (LCA) are rare inherited retinal degenerative disorders. The Visual Symptom and Impact Outcomes patient-reported outcome (ViSIO-PRO) and observer-reported outcome (ViSIO-ObsRO) instruments were developed in this population to assess visual function symptoms and impacts on vision-dependent activities of daily living (ADL) and distal health-related quality of life (HRQoL). This study aimed to explore the psychometric properties of the ViSIO-PRO and ViSIO-ObsRO in RP/LCA. METHODS: The 49-item ViSIO-PRO and 27-item ViSIO-ObsRO instruments were completed by 83 adult and adolescent patients and 22 caregivers of child patients aged 3-11 years with RP/LCA, respectively, at baseline and 12-16-day follow-up. Concurrent measures were also administered at baseline. Psychometric analyses assessed item (question) properties, dimensionality, scoring, reliability, validity, and score interpretation. RESULTS: Item responses were mainly evenly distributed across the response scale, and inter-item correlations were mostly moderate to strong (> 0.30) at baseline within hypothesized domains. Item deletion was informed by item properties, qualitative data, and clinical input and supported retention of 35 ViSIO-PRO items and 25 ViSIO-ObsRO items. Confirmatory factor analysis in line with pre-hypothesized domains supported a four-factor model assessing visual function symptoms, mobility, vision-dependent ADL, and distal HRQoL. A bifactor model supported calculation of total scores and four domain scores. Internal consistency was high for domain and total scores (Cronbach's alpha > 0.70) and test-retest reliability for total scores was strong between baseline and 12-16-day follow-up (intraclass correlation coefficients 0.66-0.98). Convergent validity was supported by strong correlations in a logical pattern with concurrent measures. Mean baseline scores differed significantly between severity groups. Distribution-based methods provided initial insights to guide interpretation of scores. CONCLUSIONS: Findings supported item reduction and established scoring of the instruments. Evidence of reliability and validity as outcome measures in RP/LCA was also reported. Further research is ongoing to explore responsiveness of the ViSIO-PRO and ViSIO-ObsRO instruments and interpretation of change scores.

The Amblyopia Quality of Life (AmbQoL): Development and Content Validation of a Novel Health-Related Quality of Life Instrument for Use in Adult and Pediatric Amblyopia Populations.

INTRODUCTION: Amblyopia is a neurodevelopmental vision disorder, characterized by poor vision in one or both eyes. Given the lack of existing clinical outcome assessments (COA) considered fit-for-purpose for amblyopia clinical trials, this study developed new COAs to assess amblyopia symptoms and health-related quality of life (HRQoL) impacts in adult and pediatric amblyopia populations that conform with best practice standards and regulatory guidelines. METHODS: Findings from a targeted qualitative literature review informed the development of three versions of the new Amblyopia Quality of Life Questionnaire (AmbQoL): a patient-reported outcome measure (PRO) for individuals aged 13 years and older, a PRO for children aged 9-12 years, and an observer-reported outcome measure (ObsRO) for caregivers of children aged 4-8 years. Qualitative interviews were conducted with the target populations, and with ophthalmologists experienced in treating amblyopia patients to evaluate the content validity for further development of the AmbQoL. A translatability assessment was conducted to ensure cultural appropriateness and usability across multiple languages. Feedback from Food and Drug Administration (FDA) was also sought on the instruments, and clinical experts provided input at key stages. RESULTS: Interviews were conducted with 112 patients/caregivers and ten ophthalmologists from the USA, France, and Germany. The instructions, items, and response options were well understood across all AmbQoL versions. Feedback from the patients, caregivers, ophthalmologists, the translatability assessment, the FDA, and the expert clinicians informed minor wording modifications to enhance clarity and translatability. Some items were removed due to low relevance. The study resulted in a 23-item adult/adolescent PRO, 24-item child PRO, and 12-item ObsRO, each employing a 7-day recall period. CONCLUSION: Each AmbQoL version has documented support for its face and content validity for use in amblyopia populations aged ≥ 4 years. Further research is necessary to evaluate the psychometric measurement properties of the AmbQoL instruments to enable their use in amblyopia treatment trials.

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.

A Social Media Listening Study to Understand the Unmet Needs and Quality of Life in Adult and Pediatric Amblyopia Patients.

INTRODUCTION: Amblyopia is an important cause of monocular vision impairment worldwide, and it negatively impacts patients' quality of life (QoL). Understanding patients' perspectives may help to optimize treatment outcomes and improve treatment adherence. METHODS: This was a non-interventional, retrospective analysis of social media data available in the public domain posted by patients and caregivers on selected social media channels (Twitter®, forums, blogs, and news) from 12 countries between July 2018 and June 2020. RESULTS: Approximately 2662 conversations relevant to the research objective were analyzed. The patient journey for adults and children was constructed based on the conversations. Eyeglasses, eye patches, contact lenses, and vision exercises were the common treatment options for amblyopia. Patients also reported vision improvement with emerging technologies such as digital therapeutics. Amblyopia and its treatment had a negative impact on QoL, and increased caregiver burden. Insurance coverage, long appointment waiting times, and recurring expenses of treatment options were reported as barriers to treatment. Non-compliance, switching between treatment options or technology, or discontinuation of treatment options was found to emanate from various issues including no improvement of the condition, discomfort with the treatment option, bullying, dissatisfaction with healthcare professional (HCP) recommendation, cost of treatment/issues with insurance coverage, side effects, and/or other unspecified reasons. The need for regular eye examinations, better diagnostic tests, awareness of the disease, awareness amongst HCPs about treatment options, and the need for better health insurance coverage policies emerged as unmet needs. CONCLUSION: This social media listening study generated insights on patients with amblyopia and their caregivers regarding the patient journey, treatment options, reasons for non-compliance, reasons for switching HCPs, barriers to treatment, and unmet needs. Further qualitative research is required to validate the findings.

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.

Comparison of real-world treatment outcomes of femtosecond laser-assisted cataract surgery and phacoemulsification cataract surgery: A retrospective, observational study from an outpatient clinic in France.

PURPOSE: This study compared real-world safety and efficacy outcomes of cataract surgery performed with LenSx femtosecond laser-assisted cataract surgery or manual phacoemulsification cataract surgery procedures. METHODS: A retrospective observational study used data from anonymised electronic medical records to compare mean cumulative dissipated energy, the proportion of eyes reaching emmetropia, mean change in best-corrected distance visual acuity and the proportion of eyes with post-surgical complications, including corneal oedema and posterior capsule opacification. Results were adjusted for multiple comparisons for primary and secondary objectives. RESULTS: Data from 811 phacoemulsification cataract surgery and 496 femtosecond laser-assisted cataract surgery procedures were analysed. Mean cumulative dissipated energy was significantly lower for femtosecond laser-assisted cataract surgery (6.5 percent-seconds) than for phacoemulsification cataract surgery (14.3 percent-seconds; p < 0.0001) procedures. More femtosecond laser-assisted cataract surgery (81.2%) procedures achieved emmetropia (⩽ 0.5 dioptre) than did phacoemulsification cataract surgery (73.5%) procedures, although this difference was not statistically significant. Mean change in best-corrected distance visual acuity and the proportion of eyes with corneal oedema, posterior capsule opacification or other complications were not significantly different between cohorts when adjusted for multiple comparisons. CONCLUSIONS: In this single-centre, single-surgeon retrospective electronic medical record database study using divide and conquer technique, femtosecond laser-assisted cataract surgery was associated with significantly lower cumulative dissipated energy when compared to manual phacoemulsification cataract surgery. This supports the hypothesis that femtosecond laser-assisted cataract surgery involves less mechanical trauma, which might lead to more consistent refractive and safety outcomes than manual phacoemulsification cataract surgery, though such outcomes were found to be comparable in this study.

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.

Three-year incidence of Nd:YAG capsulotomy and posterior capsule opacification and its relationship to monofocal acrylic IOL biomaterial: a UK Real World Evidence study.

PURPOSE: To evaluate 3-year incidence of Nd:YAG capsulotomy and PCO and compare the effect of different IOL materials. METHODS: Data were retrospectively collected from seven UK ophthalmology clinics using Medisoft electronic medical records. Eyes from patients ≥65 years undergoing cataract surgery with implantation of acrylic monofocal IOLs during 2010-2013 and 3-year follow-up were analysed. Nd:YAG capsulotomy and PCO incidence proportions were reported for 3 IOL cohorts: AcrySof, other hydrophobic and hydrophilic acrylic IOLs. Unadjusted/adjusted odds ratios (OR) of Nd:YAG capsulotomy were calculated through logistic regression for non-AcrySof cohorts versus AcrySof. A sub-group analysis in single-piece IOLs (>90% of sample eyes) was also performed. RESULTS: The AcrySof cohort included 13,329 eyes, non-AcrySof hydrophobic 19,025 and non-AcrySof hydrophilic 19,808. The 3-year Nd:YAG capsulotomy incidence (95% CI) for AcrySof (2.4%, 2.2-2.7%) was approximately two times lower than non-AcrySof hydrophobic IOLs (4.4%, 4.1-4.7%) and approximately fourfold lower than non-AcrySof hydrophilic IOLs (10.9%, 10.5-11.3%). Trends were similar in PCO incidence (AcrySof: 4.7%; non-AcrySof hydrophobic: 6.3%; non-AcrySof hydrophilic: 14.8%). Also in the analysis restricted to single-piece IOLs, the pattern remained (2.4% vs 5.1% vs. 10.9%, respectively). Adjusted regression analysis showed a approximately two and fivefold increased odds of Nd:YAG for non-AcrySof hydrophobic and hydrophilic acrylic IOLs respectively vs. AcrySof IOLs. Nd:YAG capsulotomy ORs were similar and remained statistically significant in the single-piece IOL sub-group. CONCLUSIONS: Real-world evidence shows that within 3 years following implantation, AcrySof IOLs are significantly superior in reducing Nd:YAG capsulotomy and PCO incidence compared to other hydrophilic and hydrophobic acrylic 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.