Vision-related quality of life in patients treated for myopic choroidal neovascularization: A post hoc analysis of the OLIMPIC study.

PURPOSE: To investigate vision-related quality of life in patients referred to the Italian Retina Services for intravitreal ranibizumab treatment for choroidal neovascularization due to pathologic myopia. DESIGN: Post hoc analysis of a multicenter, interventional phase IIIb study (OLIMPIC). METHODS: Patients with either previously untreated (naïve) or treated choroidal neovascularization due to pathologic myopia were enrolled. Vision-related quality of life was measured using the Italian version of the Impact of Vision Impairment Questionnaire with scores from 0 (no impact) to 5 (severe impact). Burden of illness data were collected regarding income, and personal and public resource use. RESULTS: In the 200 included subjects, mean best-corrected visual acuity in the better eye was 68.3 Early Treatment Diabetic Retinopathy Study letters (standard deviation: 15.2) compared with 42.5 Early Treatment Diabetic Retinopathy Study letters (standard deviation: 23.3) in the worse eye. The proportion of better eyes affected by choroidal neovascularization was 147/200 (73.5%). In multivariable analyses, lower better eye, but not worse eye, best-corrected visual acuity was associated with lower vision-related quality of life (per 10 fewer letters, beta: + 0.17, p < 0.001). An annual income below 20,000 euros was also associated with lower vision-related quality of life (beta: + 0.38; standard error: 0.13, p = 0.004). Moreover, in univariate analyses, increasing income level was linearly associated with better presenting best-corrected visual acuity in the better eye (p < 0.003), with a difference of 15 Early Treatment Diabetic Retinopathy Study letters for patient income <20,000 euros compared with >70,000 euros. CONCLUSION: Italian patients with myopic choroidal neovascularization and a low income presented with lower better-eye best-corrected visual acuity and lower vision-related quality of life compared with those with a higher income. Future research should investigate disease awareness and candidacy issues that may influence the quality of life of patients.

Tracing the natural course of visual acuity and quality of life in neovascular age-related macular degeneration: a systematic review and quality of life study.

BACKGROUND: Describing the natural course of neovascular age-related macular degeneration (nAMD) is essential in discussing prognosis and treatment options with patients and to support cost-effectiveness studies. METHODS: First, we performed a literature search in PubMed, Embase, and Cochrane. We included randomized clinical trials and prospective observational studies reporting visual acuity (VA) in non-treated patients, 24 studies in total. We integrated VA data using best fit on Lineweaver-Burke plots and modelled with non-linear regression using reciprocal terms. Second, we performed a quality-of-life (QoL) study in nAMD patients. We measured VA with Radner reading charts and QoL with the Health Utilities Index issue 3 (HUI-3) questionnaire in 184 participants. We studied the relation VA-QoL with linear regression. Third, with Monte Carlo simulation, we integrated the VA model from the literature review and the relation VA-QoL from the QoL study. RESULTS: Visual acuity was 0.4 and 0.07 after 5 years in the better-seeing, and worse-seeing eye, respectively. After 4.3 years, VA was <0.5 in the better-seeing eye; <0.3 after 7 years; 0.05 after 17 years. QoL score decreased from 0.6 to 0.45 after 10 years. CONCLUSIONS: The natural course of nAMD in both eyes needs to be considered when informing patients. Visual acuity in the best eye decreases to below 0.5 in 4.3 years. This affects QoL significantly.

The impact of typical neovascular age-related macular degeneration and polypoidal choroidal vasculopathy on vision-related quality of life in Asian patients.

AIMS: To determine the impact of neovascular age-related macular degeneration (nAMD) on vision-related quality of life (VRQoL) in an Asian population. METHODS: In this cross-sectional study, 162 subjects with nAMD from the Asian AMD Phenotyping Study and 105 randomly sampled age-matched and gender-matched controls from the population-based Singapore Chinese Eye Study were recruited. nAMD was categorised as either polypoidal choroidal vasculopathy (PCV) or 'typical' AMD (tAMD). The reading, mobility and emotional well-being subscales of the impact of vision impairment (IVI) scale were validated using Rasch analysis and used as the main outcome measures and collectively referred to as VRQoL. Multivariate linear regression analyses were performed to assess the impact of nAMD overall, and PCV and tAMD subtypes, on the three IVI domains. RESULTS: Of the 162 with nAMD, 103 (63.6%) had PCV and 59 (36.4%) had tAMD. In multivariate models, nAMD overall was independently associated with a 21% reduction in reading (ß=-1.08; CI -1.58 to -0.57); 16% reduction in mobility (ß=-0.74; -1.14 to -0.33) and 44% reduction in emotional well-being (ß=-2.15; -2.83 to -1.47) compared with controls. There were significant VRQoL deficits (p<0.05) associated with both PCV and tAMD; these deficits were similar and not statistically different between the two nAMD subtypes (p>0.05). CONCLUSIONS: Neovascular AMD, including both PCV and tAMD subtypes, has a detrimental impact on VRQoL in Asian subjects independent of level of vision impairment. Interventions to increase reading capacity, enhance mobility and independence and improve mental health outcomes for subjects with neovascular AMD further address the impact of the condition on VRQoL in addition to pharmacological therapies.

Distinguishing between Better and Worse Visual Acuity by Studying the Correlation with Quality of Life in Neovascular Age-Related Macular Degeneration.

PURPOSE: To determine whether there is a level of visual acuity (VA) in neovascular age-related macular degeneration (nAMD) above which the correlation of VA with disease-related quality of life (QoL) is significantly greater than below this level. DESIGN: An observational, cross-sectional study. PARTICIPANTS: A total of 184 patients with nAMD aged at least 50 years were included in the study. METHODS: In face-to-face interviews, we assessed QoL with the Macular Disease-Dependent Quality of Life (MacDQoL) questionnaire. We measured VA with standardized Radner reading charts. We used regression splines analysis with a single hinge point, with the MacDQoL score as the dependent variable and VA as the independent variable. The x-coordinate (VA) of the hinge point was varied and tested with each iteration. A second method of regression splines analysis was also performed, without a preset hinge point. MAIN OUTCOME MEASURES: The primary outcome measure is the cutoff point at or below which VA is associated with significantly less change in QoL than above this cutoff. The linear coefficients below and above the cutoff are defined as change in MacDQoL score per logarithm of the minimum angle of resolution (logMAR) unit of change in VA. RESULTS: With Snellen equivalent VA 0.05 (1.3 logMAR) or worse, the linear coefficient was 0.15. With VA better than 0.05, the linear coefficient was 2.40 (P value of the difference: 0.009). CONCLUSIONS: When VA is above 0.05, there is a stronger and significant relation between VA and QoL. At or below this level, the relation between VA and QoL approaches zero. With better VA, a difference in VA implies a significant difference in QoL. With poorer VA, a difference in VA is unlikely to imply a difference in QoL. Therefore, in treating nAMD, the aim should be to keep Snellen VA above 0.05 to have an impact on QoL. If it is certain that the best-corrected VA below 0.05 is permanent, these findings imply there may be less, if any, benefit to continue further treatment. This is to be evaluated on a case-by-case basis.

[High myopic patients: A survey of their history, feelings, beliefs and needs]. / Enquête sur l'histoire, le ressenti, les croyances et les besoins des patients myopes forts.

BACKGROUND AND OBJECTIVES: High myopia (HM), which affects 0.9 to 3.1% of the population, is a major cause of vision loss. The purpose of this investigation was to study and evaluate the impact of their high myopia on the daily lives of patients and to better understand their expectations in order to better meet their needs. MATERIALS AND METHODS: The survey was conducted between February 19 and March 21, 2014. To be eligible, patients had to have myopia of at least -8 diopters and be over 40 years of age, with or without myopic complications. Patients' degree of myopia was defined as the optical prescription of their worse eye. The 123 patients included were interviewed by phone using a questionnaire developed and validated by a scientific committee composed of experts and members of the patients' Association against myopic maculopathy (AMAM). The phone interview, semi-structured, lasted 20 minutes. RESULTS: On average, myopia was -11.7 diopters. Women accounted for 71% of the population, 89% of patients were under 65 years and were mostly professionals (65%). Over half of the subjects reported myopic complications; 5% of patients had choroidal neovascularization (CNV). Only 29% had been informed of the risk of CNV or maculopathy. HM was a handicap in sports for 64% of patients, in leisure activities for 51%, and in professional activities for more than a quarter (28%). Only 56% of HM patients reported living perfectly well with their condition. CONCLUSIONS: This survey is the first study on the daily life of people with HM aiming to analyze their social and emotional environment. It shows that HM has a profound impact on the daily lives of patients and may affect social life and professional activity. Most myopic patients possess incomplete or unclear information about the nature and risk of myopic complications. They expressed the desire to be better informed about their condition earlier, before the onset of complications.

[Evaluation of the German version of the caregiver reaction assessment questionnaire for informal caregivers of patients with neovascular age-related macular degeneration]. / Evaluierung der deutschen Version des Caregiver Reaction Assessment-Fragebogens bei betreuenden Angehörigen von Patienten mit neovaskulärer altersbedingter Makuladegeneration.

BACKGROUND: Informal caregivers of patients with loss of vision often have to give physical and emotional support because of the high level of dependence induced. Although it is known that these informal caregivers suffer a higher risk of being affected by burn-out syndrome or depression, the various dimensions of burden, especially of informal caregivers of patients with neovascular age-related macular degeneration (nv-AMD) have not yet been investigated. OBJECTIVE: The objective of this study was the evaluation of the German version of the caregiver reaction assessment (CRA) questionnaire in a collective of informal caregivers of patients with nv-AMD. In this context the positive and negative influences on the informal caregivers were assessed. MATERIAL AND METHODS: Between January 2013 and July 2014 a total of 150 informal caregivers of patients with nv-AMD filled out the CRA independently using a questionnaire survey which had been translated into German. Based on this collective, the psychometric characteristics of the translated questionnaire were evaluated. RESULTS: The informal caregivers of the current collective reported a lower burden in the five subgroups disrupted schedule, lack of family support, self-esteem, health problems and financial problems, compared to the previous CRA studies with caregivers of patients with other diseases. The informal caregivers saw the greatest burden as the disruption of their schedule. Through a principal component analysis the five subgroups could be identified as five factors. It was shown that 19 out of the 24 items could be assigned to the same factors as in the original English version. The internal consistency of the five subgroups was acceptable except for the subscale on self-esteem. CONCLUSION: In this study the CRA has been confirmed as a suitable instrument to assess both positive and negative reactions of informal caregivers related to caregiving of patients with nv-AMD. The results provide support for a five subscale structure of the CRA in the original English version but five items of the questionnaire could be assigned to another subscale.

Treatment Satisfaction and Well-Being in Patients with Myopic Choroidal Neovascularization Treated with Ranibizumab in the REPAIR Study.

The Ranibizumab for the Treatment of Choroidal Neovascularisation (CNV) Secondary to Pathological Myopia (PM): an Individualized Regimen (REPAIR) trial was a prospective study exploring the efficacy and safety of intravitreal ranibizumab 0.5 mg using an individualized treatment regimen over 12 months. The current study investigated the impact of treatment with ranibizumab as needed (pro re nata [PRN]) on individuals with myopic choroidal neovascularization (mCNV) in the REPAIR study, using patient-reported outcome measures (PROMs) for treatment satisfaction and well-being. This study included 65 adults with mCNV and a best-corrected visual acuity (BCVA) letter score of 24-78 in the study eye. Patients completed the Macular Disease Treatment Satisfaction Questionnaire (MacTSQ) at months 1, 6 and 12, and the 12-item Well-Being Questionnaire (W-BQ12) at baseline and months 1, 6 and 12. Subgroup analyses investigated the relationship between PROM scores and treatment in the better- or worse-seeing eye (BSE/WSE), number of injections received, baseline BCVA, BCVA improvement and age. Pearson correlations between change in BCVA, MacTSQ scores and W-BQ12 scores were calculated. The main outcome measures were treatment satisfaction measured with the MacTSQ (score 0-72) and well-being measured with the W-BQ12 (score 0-36). Treatment satisfaction significantly increased over the study period (p = 0.0001). Mean MacTSQ scores increased by 9.7 and 10.0 in patients treated in their WSE and BSE, respectively. Treatment satisfaction was highest in individuals receiving only one injection at month 1; however, by month 12, scores were similar across injection subgroups. Patients aged 68 years or older had the highest MacTSQ scores. Well-being scores also significantly increased over the study period (p = 0.03). Mean W-BQ12 scores increased by 1.7 in patients treated in their WSE and by 2.1 in patients treated in their BSE. Individuals aged 40 years or younger had the greatest increases in general well-being. Patients who experienced stable or improved BCVA at month 12 had greater increases in W-BQ12 scores than those who experienced a decrease. Correlations between BCVA, MacTSQ scores and W-BQ12 scores were largely non-significant. In conclusion, treatment satisfaction and well-being increased during treatment with ranibizumab PRN. Although directly comparable data are limited for the MacTSQ and W-BQ12 in mCNV, these results complement PROM outcomes reported in related studies.

The role of social deprivation in severe neovascular age-related macular degeneration.

BACKGROUND/AIMS: Advances in therapy have improved outcomes for patients with neovascular age-related macular degeneration (nAMD). Prompt access to treatment is a priority and may be used as a key performance indicator. In this study, we investigate how social deprivation may impact on access to services, treatment and visual impairment registration. METHODS: Patients were identified retrospectively through the Certificate of Visual Impairment system for the University Hospitals Birmingham Medical Retina service. The Index of Multiple Deprivation (IMD) 2007 score was calculated for each patient. The impact of deprivation, age, gender and ethnicity on key stages in the care pathway was assessed. RESULTS: 120 patients were identified. Patients with greater social deprivation were under-represented, had worse visual acuity at first presentation (correlation of the better-seeing eye with IMD 0.225 (p=0.013)) and had sight-impairment registration earlier (correlation -0.246; p=0.007). Deprivation did not affect time to first appointment, and was not associated with a higher rate of non-attendance. CONCLUSIONS: The late presentation and under-representation of patients with greater social deprivation is a serious concern. Our study strongly suggests that this vulnerable group is encountering barriers in accessing treatment in nAMD, and that these occur prior to entry into the Hospital Eye Service.

Delay in treating age-related macular degeneration in Spain is associated with progressive vision loss.

PURPOSE: To assess the impact on visual acuity of delays between diagnosis and treatment in patients with subfoveal neovascular age-related macular degeneration (NV-AMD) and to evaluate NV-AMD patients' emotional status before therapy initiation. METHODS: This retrospective, multicenter, epidemiological study included newly diagnosed NV-AMD patients registered in the Spanish national health system and referred to regional health centers for evaluation/treatment by a retinal specialist from 09/2005 to 03/2006. Records were reviewed and data abstracted at referring physicians' offices (diagnosis visit) and regional health centers (treatment visit). Treatment was at physicians' discretion. The Hospital Anxiety and Depression Scale was administered at the treatment visit (before therapy). RESULTS: Median time from the diagnosis to treatment visit was 2.3 months (95% confidence interval: 0.2-10.8 months). Vision loss had progressed at the treatment visit with a doubling in the percentage of patients with a visual acuity of 20/400 or worse (from 12.4 to 24.7%). The decrease in visual acuity from the diagnosis to the treatment visit was highly statistically significant (P<0.0001) as was the correlation between months to treatment and visual acuity change (r=0.5234, P<0.0001). Time from the diagnosis to the treatment visit remained a significant predictor of progressive vision loss when visual acuity at diagnosis and change in lesion size between diagnosis and treatment were controlled (P<0.0001). Patients with more severe vision loss prior to treatment tended to report more depression. CONCLUSIONS: Delayed treatment of patients newly diagnosed with NV-AMD is associated with substantial visual acuity loss.

Relationships between clinical measures of visual function, fluorescein angiographic and optical coherence tomography features in patients with subfoveal choroidal neovascularisation.

AIMS: To examine the relationships between measures of vision, optical coherence tomography (OCT) and fundus fluorescein angiography (FFA) characteristics in patients with exudative age-related macular degeneration (AMD). STUDY DESIGN: Retrospective case note review. Inclusion criteria were: confirmed diagnosis of new exudative AMD; recorded visual function using best corrected distance visual acuity (DVA), near visual acuity (NVA) and contrast sensitivity; corresponding FFA and OCT. FFA parameters included greatest linear diameter of lesion (GLD), area of choroidal neovascularisation (CNV) and area of leakage. OCT parameters included maximum retinal thickness (Ret(max)), central foveal thickness, maximum thickness of the CNV (CNV(max)), and the distances from the foveal depression to Ret(max) and CNV(max). RESULTS: 74 patients were included in this study. Correlations were highly statistically significant for both NVA and contrast sensitivity with GLD, CNV area and leakage (p<0.01 for all combinations). With DVA, modest statistically significant correlations were seen with CNV area and GLD (p<0.05). There was a statistically significant correlation between CNV leakage and the distance of CNV(max) to the fovea (p<0.05). The relationships between the measures of vision and OCT parameters were weak and did not reach significance. Regression analysis showed that the combination of Ret(max), GLD, and CNV(max) to fovea had the highest coefficient (r2 = 0.27). CONCLUSION: OCT measurements by themselves are not robust markers for visual function.

Quality of life in patients with age-related macular degeneration: results from the VISION study.

PURPOSE: To assess the impact of treatment with pegaptanib sodium vs usual care on vision-related quality of life (VRQoL) in patients with age-related macular degeneration (AMD). METHODS: VRQoL was a secondary end point in the trial, a prospective, randomized, double-masked, multicentre, dose-ranging study. Three doses of pegaptanib (0.3, 1, and 3 mg) were compared with usual care with respect to changes in VRQoL as indicated by the 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ 25), administered at baseline and weeks 30 and 54. Four of the NEI-VFQ 25 domains were prospectively designated as primary: near vision, distance vision, role limitations, and dependency. Between-group differences were assessed using an analysis of covariance model with age, gender, and baseline score as covariates. RESULTS: NEI-VFQ 25 data were available for 569 subjects. At week 54, improvements in the distance vision and role limitations domains were greater in pegaptanib than usual care arms. No substantial increase in ocular pain was noted in pegaptanib-treated patients. No clear superiority of any particular dosage strength of pegaptanib was demonstrated, and no significant differences or trends favoured usual care on any domain score or the NEI-VFQ 25 composite score. The greatest VRQoL benefit was seen in responders (lost<3 lines) to treatment. CONCLUSION: The VISION trial provided evidence of trends in quality-of-life benefit associated with effective treatment of AMD using pegaptanib. Treatment with pegaptanib is expected to contribute significantly to VRQoL improvement for responder patients.

Vision-related quality of life in patients suffering from age-related macular degeneration.

PURPOSE: To evaluate the relative impact of best and worst eye on vision-related quality of life in patients suffering from age-related macular degeneration (AMD). DESIGN: Quality of life and visual acuity data were collected at baseline during a randomized clinical trial. SETTING: Multicenter (11 centers), international study. PATIENTS: One hundred fourteen patients with a diagnosis of exudative AMD and primary or recurrent subfoveal neovascular membrane (greatest linear dimension of lesion < or =5400 microm; > or =50% of the total lesion was choroidal neovascularization (CNV); classic component of the total CNV > or = 1.0 mm(2)). All patients were over age 50 years, of any race, either sex. INTERVENTION OR OBSERVATION PROCEDURE: NEI-VFQ-39 questionnaire administered to patients at home by trained telephone interviewers. MAIN OUTCOME MEASURES: ETDRS visual acuity (VA) was measured in both eyes separately. Vision-related quality of life (QoL) was assessed using the NEI-VFQ-39. An analysis of variance was performed on the NEI-VFQ scores, including best eye VA (VA > 20/40 vs VA < or = 20/40), worst eye VA (VA > 20/200 vs VA < or = 20/200), and the interaction between the two as independent variables. RESULTS: Best eye VA was 0.34 on average, with VA > 20/40 in 43.0% of patients. Worst eye VA was 0.85 on average, with VA > 20/200 in 32.5% of patients. VA was not linked to general health and ocular pain scores. General Vision, Near Activities, Distance Vision, Driving, Mental Health, Role Difficulties, Dependency, Peripheral Vision, and the Global NEI-VFQ scores were affected by both best eye VA and worst eye VA. CONCLUSION: In the study sample, worst eye VA (< or =20/200) and best eye VA (< or =20/40) contributed independently to vision-related QoL. These results suggest that preserving a minimal visual acuity in the worst eye may contribute to vision-related quality of life.

Clinical outcome and subjective quality of life after photodynamic therapy in patients with age-related macular degeneration.

PURPOSE: Whereas the efficacy of photodynamic therapy (PDT) in preventing the progression of age-related macular degeneration (ARMD) is established, its effect on quality of life is under discussion. METHODS: All patients who underwent PDT during 2000 and 2001 at the University Eye Hospital of Mainz were interviewed using a standardized 82-item questionnaire on quality of life and patient satisfaction in ophthalmologic patients. Information was assessed in terms of 82 questions; global scores ranging from 1.0 (optimum self-estimated quality of life) to 4.0 (worst) were derived. Cataract patients' scores were used to characterize the ARMD patients' subjective outcome; the latter were then related to clinical outcome parameters via logistic regressions. RESULTS: A total of 84 patients (50% female, median age 77 years) were interviewed, who underwent a median of three PDT interventions. During the period of PDT treatment, their median decrease in visual acuity was 3 lines from 0.125 to 0.063. Patients who reported a subjective increase in visual function during this period showed a median private flexibility score of 1.86; patients with the subjective impression of visual function decrease, a median score of 2.71; the median scores for mobility were 2.00 versus 3.00, for flexibility in reading 1.91 versus 3.64, for psychological stress 1.56 versus 2.25, and for communicational flexibility 1.72 versus 2.25. The difference in reading flexibility was statistically significant (p=0.001) after correction for clinical cofactors. CONCLUSIONS: The established clinical benefit of PDT treatment concerning its efficacy in ARMD progression prevention coincides with an at least slight subjective benefit in quality of life and patient satisfaction. However, the latter is associated with the patients' subjective impression of visual acuity progression rather than with clinically validated outcome after PDT treatment.

Health- and vision-related quality of life among patients with ocular histoplasmosis or idiopathic choroidal neovascularization at enrollment in a randomized trial of submacular surgery: Submacular Surgery Trials Report No. 5.

OBJECTIVES: To (1) summarize vision-targeted and general health-related quality-of-life scores at baseline and quantify the effect of the ophthalmic problem, (2) evaluate the strength of relations between visual acuity and interview scores, and (3) compare scores for patients who also had choroidal neovascular lesions in the fellow eye (bilateral cases) with those of patients who had choroidal neovascularization in only the study eye (unilateral cases) at time of enrollment in a randomized trial of surgical removal of subfoveal choroidal neovascularization, either associated with the ocular histoplasmosis syndrome or of idiopathic origin. DESIGN: Eligible patients had subfoveal choroidal neovascularization (including some classic choroidal neovascularization) and a visual acuity of 20/50 to 20/800 (Snellen equivalent), inclusive, in the eye to be assigned randomly to surgery or observation. Interviews that incorporated the 39-item version of the National Eye Institute Visual Function Questionnaire (NEI-VFQ) and 2 other instruments were conducted by telephone by trained interviewers before patients enrolled and were assigned randomly to surgery or observation. Information from baseline clinical examinations and fluorescein angiograms interpreted centrally by masked readers was used to classify patients as unilateral or bilateral cases and to provide potential explanations for variability of interview responses using linear regression models. RESULTS: The median overall NEI-VFQ score was 75 (interquartile range, 60-84). The median scores on individual subscales ranged from 55 (general vision) to 100 (color vision). The visual acuity of the better-seeing eye accounted for much of the variability in scores on most NEI-VFQ subscales; a 3-line difference in visual acuity was associated with a 10-point or greater difference in scores on 5 subscales after adjustment for other characteristics of patients and eyes. Scores on most scales of all 3 instruments differed between unilateral cases (n = 167) and bilateral cases (n = 58). Even after adjustment for visual acuity and reading speed of the better-seeing eye, age, gender, and scores on the other instruments, scores on the NEI-VFQ near and distance activities subscales differed by almost 13 and 10 points, respectively, between unilateral and bilateral cases. Neither age nor gender was an important independent explanatory variable for NEI-VFQ scores. CONCLUSIONS: Unilateral and bilateral cases had vision-targeted health-related quality-of-life scores worse than those published for a reference population without eye disease. Furthermore, despite younger age, better visual acuity, and better short-term visual prognosis, bilateral cases had NEI-VFQ scores at baseline similar to those published for 2 groups of patients with age-related macular degeneration. Unidentified factors, in addition to the visual acuity of the better-seeing eye, affected patients' perceptions of visual function.

Contrast sensitivity as an outcome measure in patients with subfoveal choroidal neovascularisation due to age-related macular degeneration.

PURPOSE: Although visual acuity is the most frequently used primary outcome measure in clinical trials of treatments for choroidal neovascularisation (CNV) due to age-related macular degeneration (AMD), contrast sensitivity may provide valuable additional information. This paper reviews the evidence for using contrast sensitivity as a measure of visual function and as an outcome measure in clinical trials in patients with subfoveal CNV due to AMD. METHODS: Medline database searches were performed to retrieve relevant articles on contrast sensitivity. In addition, articles were included from the authors' knowledge of the literature and from the reference lists of retrieved articles. RESULTS: The published literature demonstrates that contrast sensitivity is an important measure of visual function in patients with subfoveal CNV due to AMD. Most clinical trials of treatments for CNV due to AMD have reported visual acuity as the primary outcome. However, there is evidence that treatment (such as verteporfin therapy) may also provide additional benefits in terms of contrast sensitivity. These benefits may not be completely characterised by measurement of visual acuity alone. CONCLUSIONS: The inclusion of contrast sensitivity as an outcome measure in studies of patients with CNV due to AMD may provide a more complete understanding of the effects of treatment on visual function and the likely benefits for patients.

Patients' perceptions of the value of current vision: assessment of preference values among patients with subfoveal choroidal neovascularization--The Submacular Surgery Trials Vision Preference Value Scale: SST Report No. 6.

OBJECTIVE: To improve understanding and awareness of the impact of subfoveal choroidal neovascularization (CNV) on health-related quality of life, we sought to measure the preference value that patients with subfoveal CNV assigned to their health and vision status. PATIENTS AND METHODS: Patients with subfoveal CNV completed telephone interviews about their quality of life prior to enrollment and random treatment assignment in the Submacular Surgery Trials, a set of multicenter randomized controlled trials evaluating outcomes of submacular surgery compared with observation. The interviewers asked patients to rate their current vision on a scale from 0 (completely blind) to 100 (perfect vision). The interviewers also asked them to rate complete blindness and then perfect vision, assuming their health otherwise was the same as it was at the time of the interview, on a scale from 0 (dead) to 100 (perfect health with perfect vision). Scores were converted to a 0 to 1 preference value scale for health and vision status, where 0 represents death and 1 represents perfect health and vision. RESULTS: Of 1015 participants enrolled in the Submacular Surgery Trials, 996 completed interviews that included the rating questions, and 792 (80%) answered all 3 rating questions in a manner permitting calculation of a single overall preference value for their current health and vision status on a scale from 0 (dead) to 1 (perfect). The mean preference value was 0.64 (median, 0.68; interquartile range, 0.51-0.80). The preference values correlated with age (Pearson correlation coefficient, -0.11; P = .002), patients' self-rated perception of overall health (Spearman correlation coefficient, 0.36; P<.001), and self-reported perception of vision (Spearman correlation coefficient, 0.47; P<.001). The preference values were significantly lower with poorer visual acuity in the better eye and greater evidence of dysfunction on either the Hospital Anxiety and Depression Scale or the Physical or Mental Component Summary scales of the Short Form-36 Health Survey but did not differ significantly by gender or other baseline characteristics such as race, treatment assignment, or size of the CNV lesion. CONCLUSIONS: Vision loss from subfoveal CNV is associated with patient preference values that are as low as or lower than values previously reported for other serious medical conditions such as dialysis-dependent renal failure and AIDS, indicating that both unilateral and bilateral CNV have a profound impact on how patients feel about their overall health-related quality of life.

Surgery for subfoveal choroidal neovascularization in age-related macular degeneration: quality-of-life findings: SST report no. 12.

PURPOSE: To describe health-related quality of life (HRQOL), overall and in patients with unilateral or bilateral choroidal neovascularization (CNV), in a clinical trial (Group N Trial) comparing observation and surgical removal of subfoveal CNV secondary to age-related macular degeneration (AMD). DESIGN: Randomized clinical trial. PARTICIPANTS: Eligible patients had untreated subfoveal CNV and AMD, best-corrected visual acuity (VA) of 20/100 to 20/800, classic CNV on fluorescein angiography, and a total subfoveal lesion size of < or =9.0 disc areas in the study eye. METHODS: Health-related quality of life data (the National Eye Institute Visual Function Questionnaire [NEI-VFQ], 36-item Short Form Health Survey [SF-36], and Hospital Anxiety and Depression Scale [HADS]) and clinical data were collected at baseline and at 6, 12, 24, 36, and 48 months. Patients were divided into unilateral and bilateral CNV subgroups based on fluorescein angiographic and clinical evidence. MAIN OUTCOME MEASURE: Two-year change in the NEI-VFQ. RESULTS: Of 454 patients enrolled, 228 were assigned to observation and 226 to surgery. At baseline, median overall NEI-VFQ scores were 67 in the observation group and 69 in the surgery group; by 2 years, the observation group had lost a median of 3 points (95% confidence interval [CI]: -6 to -2), and the surgery group gained a median of 1 point (CI: -1 to 3). The largest difference was observed for the mental health subscale, where the observation group lost a median of 5 points (CI: -5 to 0), and the surgery group gained a median of 5 points (CI: 0-10) by 2 years. Treatment differences in median 2-year changes in NEI-VFQ scores favored surgery by up to 10 points for unilateral cases and up to 8 points for bilateral cases. No treatment difference in 2-year change was observed for the SF-36 physical component summary; 2-year change in the mental component summary favored surgery by 2 points. Few patients (2%-4%) had HADS definite anxiety or depression at baseline or at 24 months. CONCLUSIONS: Although HRQOL outcomes were better in the submacular surgery arm than in the observation arm, surgery (per protocol) is not recommended because VA outcomes (reported elsewhere) were similar in the treatment arms. This article contains additional online-only material available at http://www.ophsource.com/periodicals/ophtha.

Surgery for hemorrhagic choroidal neovascular lesions of age-related macular degeneration: quality-of-life findings: SST report no. 14.

PURPOSE: To present and compare findings from health-related quality-of-life (HRQOL) interviews conducted with patients enrolled in the SST Group B Trial evaluating surgical removal of subfoveal choroidal neovascular lesions associated with age-related macular degeneration versus observation. DESIGN: Randomized clinical trial. PARTICIPANTS: Eligible patients had predominantly hemorrhagic subfoveal choroidal neovascular lesions (total lesion size of >3.5 disc areas, area of blood at least 50% of the lesion area, and at least 75% of blood posterior to the equator) and best-corrected visual acuity (VA) of 20/100 to <20/1600 but at least light perception in the study eye. Three hundred thirty-six patients enrolled after baseline quality-of-life interviews, 168 assigned to each of surgery or observation. METHODS: Clinical and HRQOL data were collected before randomization and at 6, 12, 24, 36, and 48 months after enrollment. Baseline clinical evidence was used to stratify patients as having unilateral or bilateral neovascularization at the time of randomization. The HRQOL interviews included the National Eye Institute Visual Function Questionnaire (NEI-VFQ), the 36-item Short Form Health Survey, and the Hospital Anxiety and Depression Scale. MAIN OUTCOMES MEASURE: Two-year change in NEI-VFQ. RESULTS: At 24 months after enrollment, overall NEI-VFQ scores had a median decrease of 1 point from baseline in the observation arm (95% confidence interval [CI]: -4 to 3 points) and no change in the surgery arm (95% CI: -3 to 3 points) (P = 0.70). Changes from baseline on NEI-VFQ subscales also were similar between treatment arms. Differences in scores by unilateral or bilateral involvement seen at baseline in each treatment arm persisted throughout follow-up for most outcomes. Planned analyses stratified by VA showed trends (P = 0.17) in favor of surgery at 24 months in the patients with baseline VA greater than 20/200 for the NEI-VFQ scale (3.5-point median increase from baseline in the surgery arm [95% CI: -4 to 7] vs. a 1-point median loss from baseline in the observation arm [95% CI: -6 to 4]). CONCLUSIONS: No difference was detected with respect to vision-targeted quality-of-life outcomes for patients randomized to surgery or observation in the SST Group B Trial. This article contains additional online-only material available at www.ophsource.com/periodicals/ophtha.

Health- and vision-related quality of life among patients with choroidal neovascularization secondary to age-related macular degeneration at enrollment in randomized trials of submacular surgery: SST report no. 4.

PURPOSE: To describe the effect of subfoveal choroidal neovascularization (CNV) from age-related macular degeneration (AMD) on health-related quality of life (HRQOL) of patients at enrollment in two randomized clinical trials; to examine the relation of visual acuity to HRQOL; to compare HRQOL scores between participants with unilateral and bilateral CNV independent of other characteristics. DESIGN: Randomized clinical trials. METHODS: Two Submacular Surgery Trials (SST) recruited patients with AMD and either new subfoveal CNV (Group N Trial) or predominantly hemorrhagic CNV (Group B Trial). Health-related quality of life interviews included the National Eye Institute Visual Function Questionnaire [NEI-VFQ], the SF-36 Health Survey, and the Hospital Anxiety and Depression Scale [HADS]. Linear correlation and regression analyses were used to relate baseline HRQOL scores to visual acuity and bilateral disease. RESULTS: Interview data were analyzed for 789 AMD patients: 454 patients in the Group N Trial and 335 patients in the Group B Trial. Participants reported poor vision-related functioning in many domains measured by the NEI-VFQ (mean overall scores of 65 for Group N and 63 for Group B). Visual acuity of the better eye was strongly associated with NEI-VFQ scores but not with SF-36 or HADS scores. After adjusting for visual acuity of the better eye and other factors, bilateral cases had NEI-VFQ overall scores six points lower than unilateral cases in Group N Trial and 10 points lower than unilateral cases in the Group B Trial. CONCLUSIONS: Subfoveal CNV profoundly affects vision-related quality of life. The effect is more pronounced with bilateral disease, even after controlling for visual acuity.