The Blue Mountains Eye Study is a population-based study of the
prevalence and causes of age-related vision loss, conducted in two
urban postal code areas of the Blue Mountains region near Sydney,
Australia. The study population and methods have been described
previously.
11 After a private census, all permanent
residents aged 49 years or older, were invited to participate. Of 4433
age-eligible residents, 3654 people (82.4%) aged 49 to 97,
participated from 1992 through 1994, including 2072 women and 1582 men
(mean age, 66 years). There were 68 people who died and 210 who moved
from the area (6.3%) before they could be examined. The remaining 501
people refused examination, including 353 (8.0%) who permitted a brief
interview and 148 (3.3%) who refused any participation. Residents who
attended for the examination were more likely to wear glasses currently
and to have hypertension and were less likely to have ever seen an
ophthalmologist than were nonattenders.
12 Nonparticipants
were also slightly older but had a similar gender distribution and
prevalence of doctor-diagnosed eye disease (cataract, glaucoma, and
age-related macular degeneration) to participants. Ethical approval for
the study was obtained from the Western Sydney Area Human Ethics
Committee and written, informed consent was obtained from all subjects.
The research was conducted according to the recommendations of the
Declaration of Helsinki.
A standardized questionnaire was administered by trained interviewers
that included eye and general medical histories, use of medications,
and demography. Several questions regarding myopia were included, such
as: “Do you wear glasses (that includes bifocals or multifocals) to
see clearly in the distance, or have you in the past?” and “How old
were you when you first needed to wear glasses to see clearly in the
distance?” Objective refraction was performed using an autorefractor
(model 530; Humphrey, San Leandro, CA) and was followed by subjective
refraction, according to the Beaver Dam Eye Study modification of the
Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and a
logMAR chart.
11 13 The spherical equivalent refraction
(SER) defined as the sum of the best-corrected spherical refraction
plus half the cylindrical refraction, was used to categorize current
refractive status.
The questionnaire also asked about known and potential risk factors for
cataract, including a history of diabetes, hypertension, smoking, and
use of inhaled or oral steroids. Hypertension was defined as a history
of treated hypertension and/or systolic blood pressure higher than 160
mm Hg or diastolic pressure higher than 90 mm Hg. Sun-related skin
damage to the hands, forearms, and face was assessed by a single senior
examiner (PM) and graded as none, present, mild, moderate, or severe.
At the clinic visit, a detailed eye examination was performed.
Photographs of the lens of each eye were taken after pupil dilatation
with 1% tropicamide and 10% phenylephrine drops. The protocol for
lens photography and grading closely followed the Wisconsin Cataract
Grading System
14 15 developed for the Beaver Dam Eye
Study. Slit lamp photographs were taken to assess the severity of
nuclear cataract (camera model SL-7E; Topcon Optical, Tokyo, Japan).
Retroillumination photographs of the anterior and posterior lens were
taken to assess the presence and severity of cortical and PSC cataracts
(cataract camera model CT-R; Neitz, Tokyo, Japan).
The severity of nuclear cataract on a 5-point scale was assessed by
comparing subject photographs with a set of four standard photographs.
The presence and severity of cortical cataracts were graded by placing
over the Neitz photographs a circular grid divided into eight equal
wedges and a central circle. Graders estimated the area percentage for
each of these nine segments involved by cataract. The percentages were
summed to give an estimate of the total lens area involved by cataract.
PSC cataract was graded similarly. Photographs taken of pupils less
than 4 mm in diameter were excluded from cortical cataract analyses.
All photographs were graded by one of two masked graders. The κ
values for intergrader reproducibility were 0.79 for nuclear (260
eyes), 0.78 for cortical (379 eyes), and 0.57 for PSC cataract (383
eyes). The quadratic weighted κ statistic (intraclass correlation
coefficient) was used, because this measure correlates two graders on
the same scale in reproducing the actual grade.
15 The
values for nuclear and cortical cataract represent good
reproducibility, whereas the value for PSC cataract is fair.
Data for cortical and PSC cataracts were missing from approximately 3%
of subjects because photographs were ungradable or were not taken.
Because of intermittent camera malfunction (underexposure of some
photographs), 1045 (29%) subjects did not have photographs suitable
for nuclear cataract grading. These subjects did not differ in any
important way from subjects with gradable photographs.
15
We analyzed data from both eyes, using the generalized estimating
equation method described in Zeger et al.
16 and Liang and
Zeger.
17 Although usually bilateral, both refractive error
and cataract are eye specific. The generalized estimating equation
method allows use of data from both eyes while accounting for the
correlation between the two eyes in a single subject. It affords
greater precision of estimation and is less sensitive to missing data
for some eyes.
18 Cataract was a dichotomized variable in
all analyses. Cortical cataract was considered present if 5% or more
of the lens was involved, whereas PSC cataract was considered present
if any PSC opacity was graded. Nuclear cataract was considered present
if graded level 3 or higher, in keeping with the definition of early
cataract used previously in the Beaver Dam Eye Study
19 and
in our prevalence report.
15
In the multivariate analyses, we controlled for age, sex, hypertension,
diabetes (history), smoking (current, past, or never), use of oral or
inhaled steroids (ever or never), and level of sun-related skin damage
(mild, moderate, or severe). Age was a continuous variable, whereas all
other variables were categorical. Statistical software (Statistical
Analysis System, ver. 6.12; SAS Institute, Cary, NC) was used for
statistical analysis, including generalized estimating equation
analyses. Odds ratios (OR) and 95% confidence intervals (CI) are
presented.