Cataract epidemiology.
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Biomedical subjects
Publications and source records attributed to M Cristina Leske.
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PURPOSE: To investigate whether increased fluctuation of intraocular pressure (IOP) is an independent factor for glaucoma progression. DESIGN: A cohort of patients was followed up in a randomized clinical trial. PARTICIPANTS: Two hundred fifty-five glaucoma patients from the Early Manifest Glaucoma Trial (EMGT; 129 treated and 126 control patients). METHODS: Study visits, conducted every 3 months, included ophthalmologic examinations, IOP measurements, and standard automated perimetry, with fundus photography every 6 months. Intraocular pressure values were included only until the time of progression in those eyes that showed such progression. Individual mean follow-up IOP and IOP fluctuation, calculated as the standard deviation of IOP at applicable visits, were the variables of main interest. Cox regression with time-dependent variables was used to evaluate the association between IOP fluctuation and time to progression, both with and without IOP mean in the models. These analyses also controlled for other significant variables. MAIN OUTCOME MEASURES: Glaucoma progression, as defined by a predetermined visual field criterion, worsening of the disk, assessed by an independent disc reading center, or both. RESULTS: Median follow-up time was 8 years (range, 0.1-11.1 years). Sixty-eight percent of the patients progressed. When considering mean follow-up IOP and IOP fluctuation in the same time-dependent model, mean IOP was a significant risk factor for progression. The hazard ratio (HR) was 1.11 (95% confidence interval [CI], 1.06-1.17; P<0.0001). Intraocular pressure fluctuation was not related to progression, with an HR of 1.00 (95% CI, 0.81-1.24; P = 0.999). CONCLUSIONS: These results confirm our earlier finding that elevated IOP is a strong factor for glaucoma progression, with the HR increasing by 11% for every 1 mmHg of higher IOP. Intraocular pressure fluctuation was not an independent factor in our analyses, a finding that conflicts with some earlier reports. One explanation for the discrepancy is that our analyses did not include postprogression IOP values, which would be biased toward larger fluctuations because of more intensive treatment. In contrast, in this EMGT report, no changes in patient management occurred during the period analyzed.
The hypothesized association between breast cancer and circadian disruption was evaluated in the Electromagnetic Fields and Breast Cancer on Long Island Study. Participants included 576 women with breast cancer diagnosed from August 1996 to June 1997 and 585 population-based controls (87% and 83% participation rates, respectively) aged < 75 years and living in the same Long Island, New York, home for > or = 15 years. An in-person interview ascertained light-at-night exposure histories through shift work (previous 15 years) and at home (previous 5 years). Odds ratios and 95% confidence intervals were estimated by unconditional multivariate logistic regression. Breast cancer was not associated with overall shift work (odds ratio (OR) = 1.04, 95% confidence interval (CI): 0.79, 1.38) or evening shift work (OR = 1.08, 95% CI: 0.81, 1.44). However, overnight shift workers were at lower risk than women never working shifts (OR = 0.55, 95% CI: 0.32, 0.94). Women who frequently turned on lights at home during sleep hours (> or = twice/week and > or = twice/night) had increased risks (OR = 1.65, 95% CI: 1.02, 2.69). The latter results suggest positive associations with residential light-at-night exposure, or they could reflect response biases. Furthermore, overall and evening shift work were not significant factors, and analyses of overnight shift workers yielded reduced risk estimates. The study thus provides mixed evidence for the light-at-night hypothesis.
PURPOSE: To investigate whether single nucleotide polymorphisms (SNPs) in the OPA1 gene are associated with two primary open-angle glaucoma (POAG) subgroups: those with elevated intraocular pressure (POAG/IOP) and those with normal tension glaucoma (NTG) in the African-Caribbean population of Barbados, West Indies. METHODS: SNPs at intervening sequence (IVS) 8, +4, and +32 of the OPA1 gene were directly sequenced from 48 individuals with POAG/IOP, 48 nonglaucomatous controls, and 61 people with NTG. The remaining exons of OPA1 were screened for sequence variations in the same 48 POAG/IOP participants and 48 controls by denaturing high performance liquid chromatography (dHPLC), and identified variations were confirmed by bidirectional sequencing. Genotype and allele frequencies of all SNPs were compared for statistically significant differences using the chi2 and Fisher's exact test. Haplotypes and compound genotypes were also analyzed to evaluate the combined effect of the two IVS8 SNPs. RESULTS: The analyses of the genotype and haplotype frequencies of IVS8 +4 and +32 do not show statistically significant differences between those with POAG/IOP or NTG and controls. At IVS8 +32, although there are suggestions of possible associations of the CC genotype with NTG (chi2 = 3.81, p = 0.05), and the TC genotype with POAG/IOP (chi2 = 4.23, p = 0.04), these differences do not reach statistical significance at the level of 0.017 after a Bonferroni correction. In addition, the combined genotype comparisons at IVS8 +32 do not support the association (for controls compared to NTG chi2 = 4.19, p = 0.12, df = 2; and for controls compared to POAG chi2 = 4.83, p = 0.09, df = 2). Sixteen variants are observed in the OPA1 gene, of which 10 are novel. Neither genotype nor allele frequencies of any SNP are found to be associated with POAG/IOP. CONCLUSIONS: Although some results are suggestive, there is not sufficient evidence to support an association of the SNPs evaluated in OPA1 with POAG/IOP or NTG in the African-Caribbean population of Barbados, West Indies.
OBJECTIVE: To describe temporal changes in intraocular pressure (IOP) and associated risk factors after 9 years of follow-up in a population of African descent. METHODS: Changes in IOP were evaluated in 2298 participants without glaucoma or IOP-lowering treatment at baseline. Risk factor analyses used a multiple regression approach with mixed effects, which accounted for intereye correlation. RESULTS: The mean 9-year change in IOP was small, with relatively large dispersion (mean +/- SD, 0.4 +/- 4.0 mm Hg). Only 6.5% of persons with IOP of 21 mm Hg or less at baseline had elevated IOP greater than 21 mm Hg after 9 years. Mean IOP increases were largest in persons aged 50 to 59 years at baseline (mean +/- SD, 0.9 +/- 4.3 mm Hg), whereas IOP decreased in persons 70 years or older (mean +/- SD, -0.6 +/- 4.2 mm Hg). In multivariate analyses, IOP changes were positively associated with male sex, hypertension, diabetes history, and higher systolic and diastolic blood pressure at baseline, as well as with increases in blood pressure throughout 9 years (P<.05). CONCLUSIONS: After long-term follow-up, minimal changes in IOP were observed in this African-origin population. The consistent relationships of hypertension and diabetes to IOP, a major glaucoma risk factor, underscore the public health importance of controlling these systemic conditions in black populations, where glaucoma incidence is high.
OBJECTIVE: To estimate the 9-year incidence of diabetic retinopathy (DR) in a population with the same ancestry as African Americans. METHODS: Participants with diabetes mellitus and gradable photographs at the 9-year examination were evaluated (n = 436). The incidences of minimum/moderate/severe DR, clinically significant macular edema (CSME), and sight-threatening DR (severe DR plus CSME) were defined by the development of specific diabetic changes in persons without those conditions at baseline. Progression was defined as the development of severe/proliferative DR in persons with minimum/moderate DR at baseline. RESULTS: The 9-year DR incidence was 39.6% (38.0% for minimum, 9.0% for moderate, and 2.6% for severe/proliferative DR). Incidence tended to increase with diabetes duration and treatment. Of persons with preexisting DR at baseline, 8.2% progressed to proliferative DR. The CSME incidence was 8.7%, and it increased with diabetes duration, accounting for most of the overall incidence of sight-threatening DR. CONCLUSIONS: The study provides new data on long-term incidence among persons of African origin. Results suggest a possible lower risk of severe/proliferative DR than in whites, while CSME incidence seems comparable or higher. The main component of sight-threatening DR was CSME, highlighting the importance of DR as a cause of vision loss in this population.
OBJECTIVE: To evaluate the possible relationship of hypertension and diabetes with the ABO, Rhesus, and Duffy blood groups, which are known markers of African ancestry. DESIGN: Population-based study. SETTING AND PARTICIPANTS: A random sample of 1253 Barbados residents, > or = 40 years of age. MAIN OUTCOME MEASURES: Hypertension was defined as a systolic blood pressure >140 mm Hg or a diastolic blood pressure >90 mm Hg or use of antihypertensive treatment; type 2 diabetes was defined as a glycosylated hemoglobin level >10% and/or a history of treatment in those >30 years of age. RESULTS: In logistic regression analyses, elevated diastolic blood pressure was positively associated with years of age (odds ratio [OR] 1.03, 95% confidence interval CI 1.02-1.05), the Rhesus D+ antigen (OR 2.68, 95% CI 1.21-5.97) and body mass index (OR 1.53, 95% CI 1.19-1.96), but negatively associated with the ABO blood group A allele (OR 0.68, 95% CI .48-.97). A separate logistic regression model indicated that the likelihood of diabetes increased with years of age (OR 1.03, 95% CI 1.01-1.04), hypertension (OR 1.56, 95% CI 1.10-2.20), body mass index (OR 1.68, 95% CI 1.29-2.20), and waist-hip ratio (OR 1.36, 95% CI 1.05-1.75), but decreased with presence of the Rhesus C+ antigen (OR .66, 95% CI .44-.97). CONCLUSIONS: The associations of diabetes and hypertension to these blood groups support possible genetic influences on both conditions in this and similar African-origin populations; however, further investigations in other settings are necessary to more fully elucidate these findings.
OBJECTIVE: To provide 9-year incidence estimates of age-related macular degeneration (AMD) in a population of African descent. DESIGN: Population-based cohort study. PARTICIPANTS: Two thousand seven hundred ninety-three participants (81% of eligible) after 9 years' follow-up. MAIN OUTCOME MEASURES: Nine-year incidence of AMD-related features, based on fundus photographic gradings and/or clinical examinations. RESULTS: The overall incidence rate of early AMD was 12.6% (95% confidence interval [CI], 11.0%-14.1%), and that of late AMD was 0.7% (95% CI, 0.4%-1.1%). Both increased with age (P<0.05). For early AMD, incidence ranged from 10.7% at 40 to 49 years of age to 16.8% at > or =70 years. For late AMD, incidence increased from 0.1% to 2.3% in the same age groups. Late AMD was more likely to develop in eyes with pigment changes (risk ratio [RR], 5.8; 95% CI, 2.0-16.8) and retinal pigment epithelial atrophy (RR, 5.4; 95% CI, 1.9-15.8) at baseline. Crude RRs indicated significant associations of late AMD to elevated systolic blood pressure and diabetes history, but only the diabetes relationship was suggested after adjusting for age, with borderline statistical significance (age-adjusted RR, 2.7; P = 0.054). CONCLUSIONS: Nine-year data on natural history indicate that early AMD is common in this population of African origin, although late AMD is infrequent. These long-term observations provide further evidence for the lower AMD risk in black populations compared with white populations.
OBJECTIVES: To evaluate factors related to the incidence of diabetic retinopathy (DR) in a population of African descent, after 9 years of follow-up. DESIGN: Population-based cohort study; 81% participation after 9 years. PARTICIPANTS: Three hundred twenty-four participants of the Barbados Eye Studies, with diabetes mellitus (DM) at baseline and at risk for developing DR during follow-up. METHODS: Diabetes-related changes were assessed by masked gradings of baseline and follow-up photographs using a standardized system. The 9-year cumulative incidence of DR was based on participants with DM and free of retinopathy at baseline; incidence rates were estimated by the product-limit approach. Cox regression models for discrete-time data were used to evaluate risk factors associated with the 9-year incidence of DR. RESULTS: Multivariate analyses revealed that older age at DM onset decreased the 9-year risk of DR development; for each 10 years of older age at onset, the risk of DR decreased by 30% (risk ratio [RR], 0.7; 95% confidence interval [CI], 0.56-0.96). The risk of DR doubled among persons with DM duration between 5 and 9 years (RR, 2.1; 95% CI, 1.2-3.6) versus those with shorter durations; it also doubled in those treated with oral medications or insulin at baseline versus those treated with diet only. Antihypertensive treatment halved the risk of DR versus no treatment (RR, 0.5; 95% CI, 0.3-0.9) and high systolic or diastolic blood pressure (BP) increased risk. Thus, DR risk increased by 30% for every 10 mmHg of higher systolic BP at baseline (RR, 1.3; 95% CI, 1.1-1.4) or of BP increase from baseline to the 4-year follow-up (RR, 1.3; 95% CI, 1.1-1.4). Diabetic retinopathy risk similarly increased with each 1% of higher glycosylated hemoglobin level at baseline (RR, 1.3; 95% CI, 1.2-1.5). CONCLUSIONS: The long-term follow-up of persons with DM in this population of African origin, where disease prevalence is high, identified important potentially modifiable risk factors for DR. Findings suggest that efforts to achieve optimal glycemic and BP control may reduce the vision-threatening complications of DM.
PURPOSE: To evaluate the effect of treatment, visual function, and other factors on vision-targeted health-related quality of life (HRQOL) of patients with early glaucoma. DESIGN: Randomized clinical trial. PARTICIPANTS: Two hundred fifty-five patients with newly detected open-angle glaucoma and repeatable early visual field (VF) defects, 50 to 80 years old (66% female). METHODS: Patients were randomized to receive either betaxolol plus laser trabeculoplasty in eligible eye(s) or no initial treatment and had ophthalmologic examinations every 3 months. A Swedish translation of the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) was self-administered at 2 follow-up visits (3 and 6 years after randomization). MAIN OUTCOME: Multiple linear regression analyses determined the effect of treatment and other factors on (1) VFQ-25 composite scores at the first administration and (2) change in scores between administrations. RESULTS: Two hundred thirty-three patients had 1 NEI VFQ-25 administration and 167 patients had 2 administrations. Internal consistency reliability was high for the composite VFQ-25 score (Cronbach alpha = 0.88) and satisfactory (alpha> or =0.76) for most subscale scores. At the first administration, the composite score was high (88.8+/-11.7). Mean subscale scores were also generally high (98.0-58.3) and were similar for each study group when analyzed separately. Most lower subscale scores were modestly but significantly related to worse visual acuity (VA) or mean deviation (MD) (better eye, r = 0.15-0.35). Composite scores were similar for treated and untreated patients. Lower composite scores were associated with low VA in the better eye (worse than 0.70) and worse perimetric MD (<4.16 decibels) and nuclear lens opacities (Lens Opacities Classification System II grade > or = 2), but not with age, gender, VF progression, intraocular pressure, cardiovascular disease, or hypertension. Between VFQ-25 administrations, larger decreases in the composite score were associated with larger decreases in VA (P<0.05), female gender (P = 0.001), and older age at first administration (P = 0.006). Treatment (assigned at randomization or later in the study) was not associated with change in HRQOL. CONCLUSIONS: Results suggest that absence or delay of treatment did not influence vision-targeted HRQOL in these newly diagnosed glaucoma patients. However, visual function affected vision-targeted quality of life up to 6 years after Early Manifest Glaucoma Trial enrollment.
PURPOSE: To describe 9-year changes in refractive errors and estimate incidence of myopia and hyperopia in adults of African-descent, along with associated risk factors. METHODS: The 9-year follow-up of the Barbados Eye Studies (1997-2003) reexamined 2793 surviving cohort members (81% participation). Refractive errors were determined by automated refraction. Myopia/hyperopia were defined as spherical equivalent < -0.5 diopters (D)/> +0.5 D, and the cutoff for moderate-high myopia/hyperopia was 3.0 D. Incidence rates of myopia/hyperopia were estimated by the product-limit approach, based on eyes without such conditions at baseline. Risk factors were evaluated by logistic regression in discrete time hazard models. RESULTS: Nine-year refraction changes varied by age. Persons aged 40 to 49 years experienced hyperopic shifts (median, +0.38 D), whereas persons > or =60 years had myopic shifts (median, -0.75D). Overall 9-year incidence was 12.0% for myopia and 29.5% for hyperopia; rates were 3.6% and 2.0% for moderate-high myopia and hyperopia, respectively. Myopia risk increased with age, baseline nuclear lens opacities (risk ratio [RR] = 1.7; 95% confidence interval [CI]: 1.01-2.9), glaucoma (RR = 6.0, 95% CI: 3.9-9.3), and ocular hypertension (RR = 2.0, 95% CI: 1.3-3.0), while cortical lens opacities decreased risk (RR = 0.6, 95% CI: 0.4-0.9). Incidence of moderate-high myopia was also related to baseline age, nuclear opacities, glaucoma, male gender (RR = 1.7, 95% CI: 1.0-2.8), and diabetes history (RR = 1.9, 95% CI: 1.01-3.5). Hyperopia risk decreased with older age, male gender, and glaucoma diagnosis. CONCLUSIONS: Refractive errors continue to develop frequently in older adults. Nuclear lens opacities, glaucoma, and diabetes increase the risk of older-onset myopia, a result of public health relevance to this and similar African-origin populations.
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OBJECTIVE: To evaluate risk factors for the 4-year incidence of cortical and posterior subcapsular (PSC) lens opacities. DESIGN: Population-based cohort study with 85% participation at 4-year follow-up. PARTICIPANTS: Three thousand one hundred ninety-three black participants of the Barbados Eye Studies, Barbados, West Indies, of whom 2040 and 2954 were free of cortical and PSC lens opacities, respectively, at baseline. METHODS: The standardized protocol at baseline and follow-up included an interview, anthropometric and blood pressure measurements, and ophthalmic measurements including slitlamp lens grading, fundus photography, and an ophthalmologic examination. Factors associated with incident cortical and PSC opacities (Lens Opacities Classification System II, > or =2) were evaluated by logistic regression. Main Outcome Measure Relative risks (RRs) with 95% confidence intervals. RESULTS: The 4-year incidence of cortical lens opacities was 22.2% (452/2040); the factors increasing risk were older age, female gender (RR = 1.3), low socioeconomic status (RR = 1.4), and a history of diabetes mellitus (RR = 2.4), while aspirin use was associated with a lower RR (RR = 0.2; 95% confidence interval, 0.1-0.8), a result based on small numbers. The 4-year incidence of PSC opacities was lower at 3.3% (97/2954), and risk also increased with age and a history of diabetes mellitus (RR = 2.9). A dose-response relationship was evident between incident opacities and increased levels of glycosylated hemoglobin at baseline, with the highest risk of cortical (RR = 3.60; 95% confidence interval, 2.23-5.81) and PSC (RR = 4.93; 95% confidence interval, 2.69-9.05) opacities at more than an 11.5% glycosylated hemoglobin level. CONCLUSIONS: Diabetes mellitus and hyperglycemia are major modifiable risk factors for the development of cortical and PSC lens opacities in this African-descent population with a high rate of diabetes mellitus. Prevention and improved control of diabetes mellitus are likely to reduce the burden of cataract. The finding of a reduced incidence of cortical lens opacities in aspirin users merits further investigation, given its potential for cataract prevention.
OBJECTIVE: To estimate the prevalence and distribution of open-angle glaucoma (OAG) in the United States by age, race/ethnicity, and gender. METHODS: Summary prevalence estimates of OAG were prepared separately for black, Hispanic, and white subjects in 5-year age intervals starting at 40 years. The estimated rates were based on a meta-analysis of recent population-based studies in the United States, Australia, and Europe. These rates were applied to 2000 US census data and to projected US population figures for 2020 to estimate the number of the US population with OAG. RESULTS: The overall prevalence of OAG in the US population 40 years and older is estimated to be 1.86% (95% confidence interval, 1.75%-1.96%), with 1.57 million white and 398 000 black persons affected. After applying race-, age-, and gender-specific rates to the US population as determined in the 2000 US census, we estimated that OAG affects 2.22 million US citizens. Owing to the rapidly aging population, the number with OAG will increase by 50% to 3.36 million in 2020. Black subjects had almost 3 times the age-adjusted prevalence of glaucoma than white subjects. CONCLUSIONS: Open-angle glaucoma affects more than 2 million individuals in the United States. Owing to the rapid aging of the US population, this number will increase to more than 3 million by 2020.
OBJECTIVE: To determine the prevalence of diabetic retinopathy among adults 40 years and older in the United States. METHODS: Pooled analysis of data from 8 population-based eye surveys was used to estimate the prevalence, among persons with diabetes mellitus (DM), of retinopathy and of vision-threatening retinopathy-defined as proliferative or severe nonproliferative retinopathy and/or macular edema. Within strata of age, race/ethnicity, and gender, US prevalence rates were estimated by multiplying these values by the prevalence of DM reported in the 1999 National Health Interview Survey and the 2000 US Census population. RESULTS: Among an estimated 10.2 million US adults 40 years and older known to have DM, the estimated crude prevalence rates for retinopathy and vision-threatening retinopathy were 40.3% and 8.2%, respectively. The estimated US general population prevalence rates for retinopathy and vision-threatening retinopathy were 3.4% (4.1 million persons) and 0.75% (899 000 persons). Future projections suggest that diabetic retinopathy will increase as a public health problem, both with aging of the US population and increasing age-specific prevalence of DM over time. CONCLUSION: Approximately 4.1 million US adults 40 years and older have diabetic retinopathy; 1 of every 12 persons with DM in this age group has advanced, vision-threatening retinopathy.
OBJECTIVE: To describe the 4-year incidence of visual impairment and causes of blindness among black participants of the Barbados Eye Studies. DESIGN: Population-based incidence study. SETTING AND PARTICIPANTS: The Barbados Incidence Study of Eye Diseases (BISED) followed the cohort of the Barbados Eye Study (BES), a prevalence study based on a simple random sample of Barbadians 40 to 84 years of age. BISED included 3193 black participants from the original cohort (85% of those eligible). MAIN OUTCOME MEASURES: Best-corrected visual acuity (Ferris-Bailey chart) at baseline and follow-up was measured according to a modified Early Treatment of Diabetic Retinopathy Study protocol. By use of World Health Organization (WHO) criteria, low vision and blindness for an individual were defined as visual acuity (VA) <6/18 to 6/120 and <6/120, respectively, in the better eye. By commonly used US criteria, low vision and blindness were defined as VA < or = 20/40 and < or = 20/200, respectively. Vision loss was defined as a doubling of the visual angle (i.e., decrease of 15 letters or more read correctly between baseline and follow-up examinations). Progression was defined as vision loss among those with low vision at baseline. RESULTS: On the basis of WHO criteria, the overall 4-year incidence was 3.6% (95% confidence interval [CI], 3.0%-4.4%) for low vision and 0.6% (95% CI, 0.4%-1.0%) for blindness. Incidence rates were higher using US criteria: 5.3% (95 % CI, 4.5%-6.2%) and 1.5% (95% CI, 1.1%-2.0%), respectively, reaching 21.5% and 7.3% for persons aged 70 years or older at baseline. One tenth of the cohort had vision loss, and 28.6% of those with low vision progressed. About one half of incident blindness was due to age-related cataract. Nearly one fifth was caused by open-angle glaucoma (OAG) alone or combined with cataract, and approximately 10% was caused by diabetic retinopathy (DR). CONCLUSIONS: The incidence of visual impairment was high in this Afro-Caribbean population, particularly in older age groups, indicating the public health significance of visual loss for this and similar black populations. Cataract, OAG, and DR were among the leading causes of incident blindness, paralleling their high prevalence in this population.
OBJECTIVE: To provide 9-year cumulative incidence of age-related lens opacities in a predominantly black population. DESIGN: Population-based cohort study, after 9 years of follow-up (n = 2793; 81% participation). MAIN OUTCOME MEASURES: Nine-year cumulative incidence and progression of lens opacities, by type, based on the Lens Opacities Classification System II at the slit lamp. RESULTS: Black participants had a higher 9-year incidence of overall lens changes than white participants (age- and gender-adjusted relative risk [RR], 1.8; 95% confidence interval [CI], 1.2-2.8), as well as of cortical opacities (RR, 3.2; 95% CI, 1.7-6.2). In black participants, incidence rates of any cortical and any nuclear opacities were 33.8% and 42.0%, respectively, and higher than for any posterior subcapsular (PSC) opacities (6.3%). The incidence increased with age for all 3 types, and women had a higher risk of cortical and nuclear opacities (P<0.05). Single cortical opacities were the most frequent type to develop by the 9-year follow-up (23.2%), followed by nuclear-only opacities (17.1%) and mixed opacities (15.3%). Progression rates of pre-existing opacities were 22.0% for cortical, 17.8% for nuclear, and 25.8% for PSC opacities. CONCLUSIONS: The 9-year follow-up of this cohort indicated a high incidence and progression of cortical and nuclear opacities, highlighting the public health importance of cataract in black populations.
OBJECTIVE: To describe longitudinal macular changes in a black population after 4 years of follow-up. DESIGN: Population-based incidence study. SETTING AND PARTICIPANTS: The Barbados Incidence Study of Eye Diseases (BISED) reexamined the Barbados Eye Study cohort, which was based on a random sample of the country's residents, 40 to 84 years. The BISED included 3427 persons, or 85% of the eligible cohort. MAIN OUTCOME MEASURES: Four-year incidence of macular changes, as determined by gradings of color stereoscopic macular photographs. RESULTS: Among black participants, the overall 4-year incidence of early macular changes (medium or large drusen or >20 small drusen with retinal pigment epithelium [RPE] atrophy or pigment) was 5.2% (95% confidence interval, 4.0%-6.6%) and tended to be higher in women (5.8%) than in men (4.1%). Incidence of related features was 5.2% for medium drusen (64-250 microm), 0.3% for drusen >250 microm, 1.1% for confluence, 0.5% for pigment, and 0.1% for RPE atrophy. Of the 2362 persons at risk for late macular changes (geographic atrophy, fluid, lipid, hemorrhage, disciform scar), exudative features developed in only 1 person in 4 years. Less than 1% of persons with early macular changes at baseline had disappearance of related features. CONCLUSIONS: After 4 years, the development of severe macular disease was rare in this black population, and the incidence of early macular changes also was lower than in other populations. Results are consistent with the low risk of macular degeneration in persons of African descent.