Vision-Related Quality of Life Associated with Unilateral and Bilateral Ocular Conditions.

PURPOSE: To present ophthalmic patient time-tradeoff vision utilities for quantifying vision-related quality-of-life when the fellow eye still has good vision. These utilities are important for performing reliable cost-utility analyses. DESIGN: Consecutive time-tradeoff vision utilities were obtained from ophthalmic patients with good vision (20/20-20/25) in one eye and vision ranging from 20/20 to no light perception in the fellow eye over a 15-year period from 2000 through 2014. PARTICIPANTS: Five hundred eighty-six ophthalmic participant interviews from Wills Eye Hospital, New York Eye and Ear Hospital, and ophthalmology office practices in Pennsylvania and New Jersey. METHODS: Participants underwent a full ophthalmic examination, after which time-tradeoff vision utilities were obtained by personal interview by the authors using a standardized, validated instrument. MAIN OUTCOME MEASURES: Time-tradeoff vision utilities. RESULTS: Mean time-tradeoff vision utilities were as follows in participants with good vision (20/20-20/25) in at least one eye and the following visions in the fellow eyes: no light perception, 0.79; counting fingers to light perception, 0.87; 20/200 to 20/400, 0.88; 20/60 to 20/100, 0.88; 20/30 to 20/50, 0.87; and 20/20 to 20/25, 0.94. CONCLUSIONS: In people with good vision (20/20-20/25) in one eye, the associated mean time-tradeoff vision utility is a remarkably consistent 0.87 to 0.88 when vision in the fellow eye ranges from 20/30 to light perception. Vision of 20/20 to 20/25 in the fellow eye results in a significantly higher associated utility of 0.94 (P < 0.01), whereas vision of no light perception in the fellow eye results in a significantly lower utility of 0.079 (P < 0.01). These utilities are important for calculating reliable patient value (quality-adjusted life-year) gains in ophthalmic cost-utility analysis populations in which there is unilateral and bilateral disease involvement.

Cost-Utility of Evaluation for Posterior Vitreous Detachment and Prophylaxis of Retinal Detachment.

PURPOSE: To evaluate the costs and cost-utility of examination for posterior vitreous detachment (PVD) and treatment of associated pathology, and of managing various other peripheral retinal disorders to prevent retinal detachment (RD). DESIGN: A decision analysis model of cost-utility. PARTICIPANTS: There were no participants. METHODS: Published retrospective data on the natural course of PVD, retinal tears, and lattice degeneration were used to quantitate the visual benefits of examination and treatment. Center for Medicare and Medicaid Services data were used to calculate associated modeled costs in a hospital/facility-based and nonfacility/ambulatory surgical center (ASC)-based setting. Published standards of utility for a given level of visual acuity were used to derive costs and quality-adjusted life years (QALYs). MAIN OUTCOME MEASURES: Cost of evaluation and treatment, utility of defined health states, QALY, and cost per QALY. RESULTS: The modeled cost of evaluation of a patient with PVD and treatment of associated pathology in the facility/hospital (nonfacility/ASC)-based setting was $65 to $190 ($25-$71) depending on whether a single or 2-examination protocol was used. The cost per QALY saved was $255 to $638/QALY ($100-$239/QALY). Treatment of a symptomatic horseshoe tear resulted in a net cost savings of $1749 ($1314) and improved utility, whereas treatment of an asymptomatic horseshoe tear resulted in $2981/QALY ($1436/QALY). Treatment of asymptomatic lattice degeneration in an eye in which the fellow eye had a history of RD resulted in $4414/QALY ($2187/QALY). CONCLUSIONS: Evaluation and management of incident acute PVD (and symptomatic horseshoe tears) offer a low cost and a favorable cost-utility (low $/QALY) as a result of the minimization of the cost and morbidity associated with the development of RD, thus justifying current practice standards.

SOCIETAL COSTS ASSOCIATED WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION IN THE UNITED STATES.

PURPOSE: The purpose of this study was to use a cross-sectional prevalence-based health care economic survey to ascertain the annual, incremental, societal ophthalmic costs associated with neovascular age-related macular degeneration. METHODS: Consecutive patients (n = 200) with neovascular age-related macular degeneration were studied. A Control Cohort included patients with good (20/20-20/25) vision, while Study Cohort vision levels included Subcohort 1: 20/30 to 20/50, Subcohort 2: 20/60 to 20/100, Subcohort 3: 20/200 to 20/400, and Subcohort 4: 20/800 to no light perception. An interviewer-administered, standardized, written survey assessed 1) direct ophthalmic medical, 2) direct nonophthalmic medical, 3) direct nonmedical, and 4) indirect medical costs accrued due solely to neovascular age-related macular degeneration. RESULTS: The mean annual societal cost for the Control Cohort was $6,116 and for the Study Cohort averaged $39,910 (P < 0.001). Study Subcohort 1 costs averaged $20,339, while Subcohort 4 costs averaged $82,984. Direct ophthalmic medical costs comprised 17.9% of Study Cohort societal ophthalmic costs, versus 74.1% of Control Cohort societal ophthalmic costs (P < 0.001) and 10.4% of 20/800 to no light perception subcohort costs. Direct nonmedical costs, primarily caregiver, comprised 67.1% of Study Cohort societal ophthalmic costs, versus 21.3% ($1,302/$6,116) of Control Cohort costs (P < 0.001) and 74.1% of 20/800 to no light perception subcohort costs. CONCLUSION: Total societal ophthalmic costs associated with neovascular age-related macular degeneration dramatically increase as vision in the better-seeing eye decreases.

Photopsias: A Key to Diagnosis.

PURPOSE: To assess the character and cause of photopsias in vitreoretinal patients. DESIGN: Cross-sectional study. PARTICIPANTS: A total of 169 consecutive patients (217 eyes) with vitreoretinal disease presenting with a history of photopsias. METHODS: A total of 217 eyes with photopsias in 169 patients were evaluated. Photopsia assessment included (1) laterality (unilateral, bilateral but not simultaneous, bilateral, and simultaneous); (2) morphology (flash, zig-zag, strobe, scintillating scotoma, twinkling, other); (3) color (white, silver, yellow, combination, other); (4) location (temporal, central, other); (5) duration (quick, prolonged, constant, other); (6) frequency; (7) diurnal appearance (day, night, both); (8) stimuli (turning head or eyes, hypoglycemia, hyperglycemia, other); and (9) associated systemic or ocular signs and symptoms (headache, numbness, weakness, vertigo, syncope, diplopia, hypotension, floaters, other). MAIN OUTCOME MEASURES: Clinical photopsia features correlated with the causes of photopsias. RESULTS: Thirty-two photopsia causes were identified. The top 16 included posterior vitreous detachment (PVD) in 39.7% of eyes; retinal tear in 8.9% of eyes; neovascular age-related macular degeneration (AMD) in 7.9% of eyes; rhegmatogenous retinal detachment (RRD) in 7.5% of eyes; classic and ophthalmic migraine in 6.5% of eyes; hypoglycemia in 2.8% of eyes; vertebrobasilar insufficiency in 2.8% of eyes; non-AMD choroidal neovascularization in 2.3% of eyes; retinitis pigmentosa in 1.9% of eyes; severe cough in 1.9% of eyes; central serous chorioretinopathy in 1.4% of eyes; intraocular lens reflections in 0.9% of eyes; blue field entoptic phenomenon in 0.9% of eyes; Charles Bonnet syndrome in 0.9% of eyes; digitalis in 0.9% of eyes; and metastatic adenocarcinoma to the brain in 0.9% of eyes. The photopsias associated with PVD are typically quick (96%), with lightning/flash morphology (96%), white (87%), temporally located (86%), associated with new-onset floaters (85%), preferentially seen in dark (90%) rather than lighted environments (29%), and often initiated by head/eye movements (60%). Retinal detachment had a similar profile, but with more nontemporal photopsias (40%) (P = 0.01). The photopsias from neovascular AMD are more centrally located (83%), quick and repetitive (79%), seen in light (73%) and dark (63%) environments, have no inciting stimuli (84%), and are more likely to be nonwhite (40%). CONCLUSIONS: A pointed history for photopsias can reveal a cause that may not initially seem apparent. Thus, the history can play a key role in management decisions.

The Cost-Effectiveness of Ranibizumab for the Treatment of Diabetic Macular Edema.

PURPOSE: To assess the incremental, comparative effectiveness (patient value gain) and cost effectiveness (financial value gain) associated with 0.3-mg intravitreal ranibizumab injection therapy versus sham therapy for diabetic macular edema (DME). DESIGN: Value-Based Medicine (Center for Value-Based Medicine, Flourtown, PA) 14-year, cost-utility analysis using patient preferences and 2012 United States real dollars. PARTICIPANTS: Published data from the identical Ranibizumab Injection in Subjects with Clinically Significant Macular Edema with Center Involvement Secondary to Diabetes Mellitus (RISE and RIDE) clinical trials. METHODS: An incremental cost-utility analysis was performed using societal and third-party insurer cost perspectives. Costs and outcomes were discounted with net present value analysis at 3% per annum. MAIN OUTCOME MEASURES: The incremental comparative effectiveness was measured in: (1) quality-adjusted life year (QALY) gain and (2) percent patient value (quality-of-life) gain. Cost effectiveness was quantified with the cost-utility ratio (CUR) measured as $/QALY. RESULTS: The 14-year, incremental patient value gain conferred by intravitreal ranibizumab therapy for diabetic maculopathy was 0.9981 QALY, equating to an 11.6% improvement in quality of life. The direct, ophthalmic medical cost for ranibizumab therapy in 1 eye was $30 116, whereas for 2 eyes it was $56 336. The direct, nonophthalmic, medical costs saved from decreased depression, injury, skilled nursing facility admissions, nursing home admissions, and other vision-associated costs totaled $51 758, resulting in an overall direct medical cost of $4578. The net mean societal cost for bilateral ranibizumab therapy was -$30 807. Of this total, decreased caregiver costs accrued a $31 406 savings against the direct medical costs, whereas decreased wage losses accrued a $3978 savings. The third-party insurer CUR for bilateral ranibizumab therapy was $4587/QALY. The societal cost perspective for bilateral therapy was -$30 807/QALY, indicating that ranibizumab therapy dominated sham therapy because it conferred both a positive QALY gain of 0.9981 and a financial value gain (positive financial return on investment) of $30 807 referent to the direct ophthalmic medical costs expended. CONCLUSIONS: Intravitreal ranibizumab therapy for the treatment of DME confers considerable patient (human) value gain. It also accrues financial value to patients, public and private insurers, and society.

Long-Term Results from an Epiretinal Prosthesis to Restore Sight to the Blind.

PURPOSE: Retinitis pigmentosa (RP) is a group of inherited retinal degenerations leading to blindness due to photoreceptor loss. Retinitis pigmentosa is a rare disease, affecting only approximately 100 000 people in the United States. There is no cure and no approved medical therapy to slow or reverse RP. The purpose of this clinical trial was to evaluate the safety, reliability, and benefit of the Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) in restoring some visual function to subjects completely blind from RP. We report clinical trial results at 1 and 3 years after implantation. DESIGN: The study is a multicenter, single-arm, prospective clinical trial. PARTICIPANTS: There were 30 subjects in 10 centers in the United States and Europe. Subjects served as their own controls, that is, implanted eye versus fellow eye, and system on versus system off (native residual vision). METHODS: The Argus II System was implanted on and in a single eye (typically the worse-seeing eye) of blind subjects. Subjects wore glasses mounted with a small camera and a video processor that converted images into stimulation patterns sent to the electrode array on the retina. MAIN OUTCOME MEASURES: The primary outcome measures were safety (the number, seriousness, and relatedness of adverse events) and visual function, as measured by 3 computer-based, objective tests. RESULTS: A total of 29 of 30 subjects had functioning Argus II Systems implants 3 years after implantation. Eleven subjects experienced a total of 23 serious device- or surgery-related adverse events. All were treated with standard ophthalmic care. As a group, subjects performed significantly better with the system on than off on all visual function tests and functional vision assessments. CONCLUSIONS: The 3-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind from RP. Earlier results from this trial were used to gain approval of the Argus II by the Food and Drug Administration and a CE mark in Europe. The Argus II System is the first and only retinal implant to have both approvals.

Financial return-on-investment of ophthalmic interventions: a new paradigm.

PURPOSE OF REVIEW: Although the patient value gain (improvement in quality-of-life and/or length-of-life) has been highlighted in Value-based Medicine cost-utility analyses, the financial value gain associated with healthcare interventions has received less emphasis. It is important for professional healthcare providers to realize their interventions often confer a large financial return-on-investment (ROI) to society. RECENT FINDINGS: The societal costs associated with vitreoretinal and other ophthalmic interventions include: direct ophthalmic medical costs expended (hospital, physician, drug, diagnostic testing and so forth), direct medical costs saved (decreased costs for depression, injury, skilled nursing facility, nursing home and others), direct nonmedical costs saved (decreased costs for caregivers, transportation, residence costs, moving costs, and others), and indirect medical costs saved (improving employment incidence and wages). The financial ROI for direct ophthalmic medical costs expended for ranibizumab therapy for neovascular age-related macular degeneration is 450%, whereas that for cataract surgery is 4500% and for medical open-angle glaucoma therapy is 4000%. Many costs gained add to the Gross Domestic Product and increase the wealth of the nation. SUMMARY: Many vitreoretinal and other ophthalmologic interventions confer considerable patient value, but also result in a large financial ROI to society. This financial ROI increases the wealth of the nation.

Educational Costs Expended and Career Incomes in Advanced Healthcare Professions.

The financial desirability of dollar/time investments in postbaccalaureate healthcare professional education is needed. We therefore compared postbaccalaureate educational costs and career earnings for nurse anesthetists, eight other advanced degree, nonphysician professions, and 14 physician specialties with internal rate of return (IRR) and net present value (NPV) analysis. The IRR and NPV integrated educational costs (tuition, finance charges, lost salary opportunity costs), and career earnings using U.S. Bureau of Labor and Medscape 2022 Physician Compensation Report data. Costs were discounted to 2022 U.S. real dollars using the 3.97% 50-year, U.S. average inflation rate. Annual IRRs for educational investment were 1) hospital CEOs = 48.8%; 2) managed care finance directors = 48.2%; 3) Doctors of Nurse Anesthesia Practice = 26.0%; 4) specialist physicians = 20.3%; 5) primary care physicians = 19.2%; 6) Doctors of Physical Therapy = 18.8%; 7) healthcare attorneys = 18.4%; 8) Doctors of Dental Surgery (dentists) = 18.1%; 9) Doctors of Pharmacy = 17.2%; and 10) Advanced Nurse Practitioners = 10.8%. Considering the educational money/time invested for career monetary returns, the financial desirability of nurse anesthetist and nonphysician, healthcare executive education exceeded that of physicians. Lifetime earnings for nurse anesthetists exceeded those of Doctors of Dental Surgery (Doctors of Dental Medicine), Doctors of Pharmacy, Doctors of Physical Therapy, managed care MBAs, biomedical engineers, healthcare attorneys, and Advanced Nurse Practitioners.

Interventions for toxoplasma retinochoroiditis: a report by the American Academy of Ophthalmology.

OBJECTIVE: To evaluate the available evidence in peer-reviewed publications about the outcomes and safety of interventions for toxoplasma retinochoroiditis (TRC). METHODS: Literature searches of the PubMed and the Cochrane Library databases were conducted last on July 20, 2011, with no date restrictions. The searches retrieved 275 unique citations, and 36 articles of possible clinical relevance were selected for full text review. Of these 36 articles, 11 were deemed sufficiently relevant or of interest, and they were rated according to strength of evidence. RESULTS: Eight of the 11 studies reviewed were randomized controlled studies, and none of them demonstrated that routine antibiotic or corticosteroid treatment of TRC favorably affects visual outcomes or reduces lesion size. There is level II evidence from 1 study suggesting that long-term treatment with combined trimethoprim and sulfamethoxazole prevented recurrent disease in patients with chronic relapsing TRC. Adverse effects of antibiotic treatment were reported in as many as 25% of patients. There was no evidence supporting the efficacy of other nonmedical treatments such as laser photocoagulation. CONCLUSIONS: There is a lack of level I evidence to support the efficacy of routine antibiotic or corticosteroid treatment for acute TRC in immunocompetent patients. There is level II evidence suggesting that long-term prophylactic treatment may reduce recurrences in chronic relapsing TRC. Adverse effects of certain antibiotic regimens are frequent, and patients require regular monitoring and timely discontinuation of the antibiotic in some cases.

Cataract surgery cost utility revisited in 2012: a new economic paradigm.

OBJECTIVE: To assess the 2012 cost utility of cataract surgery in the United States and to compare 2012 cost-utility data with those from 2000. DESIGN: Value-Based Medicine (Flourtown, PA), patient preference-based, comparative effectiveness analysis and cost-utility analysis using 2012 real United States dollars. PARTICIPANTS: Previously published Patient Outcomes Research Team Study data and time tradeoff utilities obtained from patients with vision loss. Visual acuity measurements from patients wtih untreated cataract were used as controls. INTERVENTION: Thirteen-year, average, first-eye and second-eye cataract surgery cost-utility analysis using the societal and third-party insurer cost perspectives. MAIN OUTCOME MEASURES: Patient value gain in quality-adjusted life years (QALYs) and percent gain in quality of life as well as the cost-utility ratio using the dollars expended per QALY gained. Patient and financial value outcomes were discounted at 3% annually with net present value analysis. RESULTS: First-eye cataract surgery conferred 1.6212 QALYs over the 13-year model, a 20.8% quality-of-life gain. Bilateral cataract surgery conferred 2.8152 QALYs over 13 years, a 36.2% improvement in quality of life. The direct ophthalmic medical cost for unilateral cataract surgery in 2012 United States nominal dollars was $2653, an inflation-adjusted 34.2% less than in 2000 and 85% less than in 1985. The 2012 inflation-adjusted physician fee was 10.1% of that in 1985. The 13-year societal cost perspective, financial return on investment (ROI) for first-eye cataract surgery was $121,198, a 4567% gain. The third-party insurer cost perspective average cost-utility ratio was $2653/1.6212 = $1636/QALY for unilateral cataract surgery, whereas the societal cost perspective average cost-utility ratio was -$121,198/1.6212 = -$74,759/QALY. The net 13-year $123.4-billion financial ROI from a 1-year cohort of cataract surgery patients was accrued: Medicare, $36.4 billion; Medicaid, $3.3 billion; other insurers, $9.6 billion; patients, $48.6 billion; and increased United States national productivity, $25.4 billion. CONCLUSIONS: Cataract surgery in 2012 greatly improved quality of life and was highly cost effective. It was 34.4% less expensive than in 2000 and 85% less expensive than in 1985. Initial cataract surgery yielded an extraordinary 4567% financial ROI to society over the 13-year model.

Update on value-based medicine.

PURPOSE OF REVIEW: To update concepts in Value-Based Medicine, especially in view of the Patient Protection and Affordable Care Act. RECENT FINDINGS: The Patient Protection and Affordable Care Act assures that some variant of Value-Based Medicine cost-utility analysis will play a key role in the healthcare system. It identifies the highest quality care, thereby maximizing the most efficacious use of healthcare resources and empowering patients and physicians.Standardization is critical for the creation and acceptance of a Value-Based Medicine, cost-utility analysis, information system, since 27 million different input variants can go into a cost-utility analysis. Key among such standards is the use of patient preferences (utilities), as patients best understand the quality of life associated with their health states. The inclusion of societal costs, versus direct medical costs alone, demonstrates that medical interventions are more cost effective and, in many instances, provide a net financial return-on-investment to society referent to the direct medical costs expended. SUMMARY: Value-Based Medicine provides a standardized methodology, integrating critical, patient, quality-of-life preferences, and societal costs, to allow the highest quality, most cost-effective care. Central to Value-Based Medicine is the concept that all patients deserve the interventions that provide the greatest patient value (improvement in quality of life and/or length of life).

Cost-Utility Analysis of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration.

PURPOSE: To quantify the cost-utility ratio of the ranibizumab Port Delivery System (PDS; SUSVIMO) versus intravitreal ranibizumab injections for treating neovascular age-related macular degeneration (nAMD) based upon Archway Phase 3 Trial data. DESIGN: Cost-utility analysis. SUBJECTS: Archway Phase 3 Clinical Trial nAMD participants previously responsive to anti-VEGF therapy were randomized 3:2. Two hundred forty received PDS refills q 24 weeks and 162 received ranibizumab injections. METHODS: Ophthalmic patient, time tradeoff utilities, direct medical and societal cost perspectives, 12-year, 1-year, and 5-year timelines, United States 2022 real dollars, and a 3% annual discount rate were employed. Utilities were adjusted for nAMD conversion in fellow eyes during the 12-year, mean participant life expectancy. Premature death associated with severe vision loss was integrated as per the population-based Salisbury Eye Evaluation Study. MAIN OUTCOME MEASURES: Quality-adjusted life-year (QALY) accruals, costs, and incremental and average cost-utility ratios in $/QALY (dollars expended per QALY gained). RESULTS: Versus no therapy, the 1-year PDS QALY gain was 0.0156 (6.8%) versus 0.0063 (0.82%) for intravitreal injections (P < 0.001), whereas the respective 12-year QALY gains were 1.714 (28%) and 1.639 (26.8%) (P = 0.99). One-year direct PDS ophthalmic costs totaled $21 825 with 2 ranibizumab fills, whereas ranibizumab injection therapy totaled $18 405 with 11.8 injections. The 1-year incremental PDS $/QALY versus injections was cost effective at $75 497/QALY. Five-year PDS therapy was not incrementally cost effective at $304 108/QALY, nor was the 12-year therapy at $761 646/QALY. Average 12-year cost-utility ratios were $78 773/QALY for the PDS and $47 917/QALY for injection therapy. Adding -$476 442 12-year offsetting societal costs netted $314 521 to society per PDS participant versus $370 958 per participant for injection therapy. CONCLUSIONS: Ranibizumab PDS therapy was not incrementally cost effective versus ranibizumab injection therapy at 12 or 5 years but was at 1 year. Injection therapy had a more favorable 12-year average cost-utility ratio. Vision gain was the major determinant of participant value gain and was the same for both interventions. Both interventions were highly cost effective utilizing average cost-utility analysis with the societal cost perspective. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Quality of life associated with no light perception vision.

OBJECTIVE: Time trade-off (TTO) utility analysis quantifies the quality of life associated with best-seeing-eye (BSE) vision. We compared the patient quality of life associated with unilateral and bilateral no light perception (NLP) with that of a control cohort without NLP. DESIGN: Cross-sectional interviews using a validated, reliable TTO vision utility analysis instrument. PARTICIPANTS: A total of 1598 consecutive ophthalmology patients from the authors' practices. METHODS: Patient records were reviewed in a case-control fashion The utilities of participants with unilateral or bilateral NLP vision were compared with those from patients without NLP vision. RESULTS: Among 99 NLP patients, 93 (94%) had unilateral NLP and 6 (6%) had bilateral NLP, for a total of 105 NLP eyes. Multiple regression analysis demonstrated the highest correlation between utility and BSE acuity (p = 0.001), with no correlation with age, ophthalmic disease, time of vision loss, race, or education. Mean unilateral NLP utility ranged from 0.55 in the counting fingers to light perception subcohort to 0.80 in the 20/20-20/25 subcohort. The 6-person bilateral NLP subcohort had a 0.54 utility. The 99-patient NLP cohort mean utility was 0.69, a 55% quality-of-life decrease versus a BSE vision-matched 0.80 in 1499 non-NLP patients (p < 0.001). CONCLUSIONS: TTO utility in unilateral NLP patients correlated with BSE vision at a lower utility than in patients with matched BSE vision without fellow-eye NLP. Decreased unilateral NLP patient quality of life should be considered in cost-utility analysis and clinical management. Bilateral NLP patient utility (0.54) was slightly less than that (0.55) in blind unilateral NLP patients with fellow-eye counting fingers to light perception vision, suggesting that more study is needed.

Prevention Surpasses Treatment: 5-year Follow-Up, Cost-Utility, and Cost-Benefit of Zeaxanthin Therapy for Neovascular Age-Related Macular Degeneration.

INTRODUCTION: Oral administration of zeaxanthin (Zx) 20 mg daily in patients with unilateral neovascular age-related macular degeneration (nAMD) treated with triple therapy (photodynamic therapy/intravitreal bevacizumab/intravitreal dexamethasone) reduced fellow-eye 2-year nAMD incidence from 23 to 6% (p = 0.02) in a prior clinical trial. We questioned the long-term benefit and thus analyzed case-control 5-year patient data of trial participants and additional participants with 5-year follow-up, also performing cost-utility and cost-benefit analyses. METHODS: Consecutive, unilateral nAMD patient outcomes for those taking 20 mg Zx supplementation orally for ≥ 5 years were compared with the Comparison of AMD Treatments Trials (CATT) 5-year historical controls for fellow-eye nAMD conversion. Eleven-year mean life expectancy, cost-utility and cost-benefit models were undertaken employing a 3% discount rate and 2020 US real dollars. RESULTS: Among 227 consecutive patients with nAMD/Zx-supplementation, 202 (90%) had 5-year follow-up. The fellow-eye nAMD 5-year conversion incidence using a Kaplan-Meier cumulative event estimate was 22% (49/227), versus 48% (167/348) with CATT control data (p < 0.0001). An 11-year cost-utility model with estimates for years 6-11 demonstrated a 0.42 (7.7%) QALY (quality-adjusted life-year) gain, including 3 months of life saved per patient due to decreased nAMD fellow-eye conversion. This yielded a direct ophthalmic medical cost perspective, incremental cost-utility ratio (CUR) of -$576/QALY and a societal cost perspective CUR of -$125,071/QALY. Zx supplementation for all 2020 US unilateral nAMD cases would have theoretically saved society, primarily patients, $6.0 billion over 11 years, a 1531% return on investment (ROI), or 31.3% annual ROI, on Zx costs. CONCLUSIONS: Oral zeaxanthin supplementation for unilateral nAMD patients appears to decrease fellow-eye long-term incidence and is cost-effective and financially rewarding. It is dominant vs. no supplementation in patients presenting with unilateral nAMD. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01527435.

Anti-vascular endothelial growth factor pharmacotherapy for diabetic macular edema: a report by the American Academy of Ophthalmology.

OBJECTIVE: To review the evidence regarding the safety and efficacy of current anti-vascular endothelial growth factor (VEGF) pharmacotherapies for the treatment of diabetic macular edema (DME). METHODS: Literature searches last were conducted in September 2011, in PubMed with no date restrictions, limited to articles published in English, and in the Cochrane Library without a language limitation. The combined searches yielded 532 citations, of which 45 were deemed clinically relevant for the authors to review in full text and to assign ratings of level of evidence to each of the selected studies with the guidance of the panel methodologists. RESULTS: At this time, there are 5 studies that provide level I evidence for intravitreal ranibizumab, alone or in combination with other treatments for DME. There is also 1 study that provides level I evidence for intravitreal pegaptanib sodium for DME. Nine studies reviewed were rated as level II, and 2 additional studies reviewed were graded as level III. Most studies do not provide information about long-term results (i.e., more than 2 years of follow-up) or the comparative efficacy of anti-VEGF pharmacotherapies. CONCLUSIONS: Review of the available literature indicates that anti-VEGF pharmacotherapy, delivered by intravitreal injection, is a safe and effective treatment over 2 years for DME. Further evidence is required to support the long-term safety of these pharmacotherapies and their comparative efficacy.

Preference-based comparative effectiveness and cost­effectiveness: a review and relevance of value-based medicine for vitreoretinal interventions.

PURPOSE OF REVIEW: This analysis discusses the comparative effectiveness and cost-effectiveness of vitreoretinal interventions, measured in quality-adjusted life years (QALYs) and percentage patient value (PPV gain, or improvement in quality of life and/or length of life). The material is relevant since the Patient Protection and Affordable Care Act enacted by Congress with the support of the President has emphasized the critical importance of patient-based preferences. RECENT FINDINGS: The majority of preference-based, comparative effectiveness and cost-effectiveness vitreoretinal interventions assessed in the US healthcare literature are Value-Based Medicine analyses, thus comparable. These interventions confer a mean patient (human) value gain (improvement in quality of life) of 8.3% [SD 6.3%, 95% confidence interval (CI) + 2.6%]. The average cost-utility of these vitreoretinal interventions is US$23 026/QALY (SD US$24 508, 95% CI + US$8770). Most vitreoretinal interventions are very cost effective using a conventional US standard of US$50 000/QALY as the upper anchor for a very cost-effective intervention, and the World Health Organization of approximately US$142 200/QALY as the upper anchor for a cost-effective intervention. CONCLUSIONS: Most vitreoretinal interventions confer considerable patient value and are very cost effective. Further standardization across healthcare is needed in the preference-based, comparative and cost-utility (cost-effectiveness) arena. The metrics of PPV (percentage patient value) gain and US$/PPV (dollars expended per percentage patient value gain) or financial value gain may be more user-friendly than the QALY.

Preference-based comparison of quality of life associated with vision loss in Black and White ophthalmic populations in the US.

PURPOSE: Utilities are preference-based estimates, typically ranging from 1.00 (normal health) to 0.00 (death), that quantify the quality-of-life improvement associated with a health care intervention. In conjunction with length-of-life gain, depending on the intervention, they measure total interventional value gain in quality-adjusted life years that can be integrated with costs in cost-utility analysis. We believed it relevant to ascertain whether race was a differentiating factor confounding utilities related to vision. METHODS: An analysis of cross-sectional data obtained from consecutive Black and White ophthalmic outpatients from the Wills Eye Hospital (Philadelphia, PA.) practices who participated in a long-standing time trade-off (TTO) vision utility study from 1999 to 2016 was undertaken. Each participant was interviewed by a researcher using a previously validated and reliable TTO vision utility acquisition instrument and assigned to 1 of 5 vision categories according to acuity in the best-seeing eye. Utility outcomes were compared using both the 2-sided t test and the Mann-Whitney U test. RESULTS: Eleven hundred and twenty-five consecutive patients able to successfully answer the questions were included. For vision of 20/200-20/800, White/Black mean vision utilities were, respectively, 0.58/0.59 (p = 0.84); for vision of 20/70-20/100, they were, respectively, 0.72/0.70 (p = 0.85); for vision of 20/50-20/60, they were, respectively, 0.78/0.79 (p = 0.86); for vision of 20/25-20/50, they were, respectively, 0.84/0.88 (p = 0.16); and for vision of 20/20, they were, respectively, 0.91/0.90 (p = 0.43). CONCLUSIONS: TTO vision utilities in Black and White ophthalmic patient cohorts were alike at various levels of visual acuity. This suggests a similar quality of life and that TTO vision utilities used in cost-utility analysis do not require adjustment for race in Black and White ophthalmic populations in the US.

Outcomes and risk factors associated with endophthalmitis after intravitreal injection of anti-vascular endothelial growth factor agents.

OBJECTIVE: To describe outcomes of and risk factors for endophthalmitis after intravitreal anti-vascular endothelial growth factor (VEGF) injection. DESIGN: Single-center, consecutive, case series and retrospective case-control study. PARTICIPANTS: Between January 1, 2009, and May 31, 2010, 16 vitreoretinal surgeons administered a total of 27 736 injections. During this period, 23 cases of presumed infectious endophthalmitis occurred. Each surgeon used his own preferred injection technique. INTERVENTION: Vitreous or aqueous tap, or both, with intravitreal antibiotic injection and subsequent topical antibiotic and steroid drops. MAIN OUTCOME MEASURES: Visual acuity, bladed lid speculum use, conjunctival displacement, hemisphere of injection, bevacizumab versus ranibizumab, and infectious organism. RESULTS: Seven of 23 cases had positive culture results; 3 grew coagulase-negative Staphylococcus. All cases had pain and vitritis on average 3.4 days (range, 1-6 days) after injection, with no difference between culture-positive and culture-negative groups. Eighteen (78%) of 23 cases had a hypopyon. Fifteen of 23 cases returned to baseline vision (±2 lines) within 3 months. Neither lid speculum use (0.10% vs. 0.066% in the no-use group; P = 0.27), conjunctival displacement (0.11% vs. 0.076% in the no-displacement group; P = 0.43), hemisphere of injection (0.11% superior vs. 0.079% inferior; P = 0.56), or bevacizumab versus ranibizumab (0.11% vs. 0.066%; P = 0.21) affected risk. Analysis of only culture-positive results yielded similar results. There was no statistically significant difference between the proportion of culture-negative cases after bevacizumab injection (83%) versus ranibizumab injection (55%; P = 0.13). CONCLUSIONS: Most patients in whom presumed infectious endophthalmitis develop after anti-VEGF injection regained baseline vision after treatment. Bladed lid speculum use, conjunctival displacement, hemisphere of injection, and type of anti-VEGF agent did not affect risk. No difference in culture-negative endophthalmitis rates was detected after bevacizumab versus ranibizumab injection. Neither the presence of pain, vitritis, decreased vision, hypopyon, nor the interval between injection and development of symptoms differentiate culture-positive from culture-negative cases. Because a subgroup of patients had poor outcomes, a low threshold for vitreous tap with intravitreal antibiotic injection may be warranted. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.