com
Global issues
ABSTRACT
Objective The present population-based study was
undertaken to estimate the prevalence, determinants and
causes of corneal morbidity and blindness in a rural
North Indian population.
Design Population-based study in India with 12 899
participants of all ages.
Methods Participants were recruited from 25 village
clusters of district Gurgaon, Haryana, India using random
cluster sampling strategy. All individuals were examined
in detail with a portable slit lamp for evidence of any
corneal disease during the door-to-door examination.
Comprehensive ocular examination including logMar
visual acuity, slit lamp biomicroscopy, non-contact
tonometry and dilated retinal evaluation was performed
at a central clinic site in the respective villages.
Results Overall, 12 113 of 12 899 people (93.9%
response rate) were examined during the household
visits. Prevalence of corneal disease was 3.7% (95%
CI 3.4% to 4.1%) and that of corneal blindness was
0.12% (95% CI 0.05% to 0.17%). Multivariable
analysis demonstrated that corneal disease was
signicantly higher in the elderly ( p<0.0001) and
illiterates ( p<0.0001). Common causes of corneal
opacity in the study population were pterygium (34.5%),
ocular trauma (22.3%) and infectious keratitis (14.9%).
Corneal diseases contributing to blindness were postsurgical bullous keratopathy (46.2%) and corneal
degenerations (23.1%).
Conclusions The study ndings demonstrate that
currently ocular trauma, infectious keratitis, post-surgical
bullous keratopathy, and corneal degenerations are
responsible for the major burden of corneal blindness
and morbidity in the Indian population. The prevalence
of corneal morbidity due to vitamin A deciency and
trachoma was low in this rural population.
INTRODUCTION
METHODS
Study design and population
The Corneal Opacity Rural Epidemiological
(CORE) study is a cross-sectional study involving
cluster random sampling. It was conducted from
July 2011 to January 2013 to determine the prevalence and determinants of corneal opacity in the
rural regions of Gurgaon district, state of Haryana,
India. A sample size of 9640 was calculated assuming 4% prevalence of corneal opacity,13 design
effect of 2, 0.6% absolute precision, and response
rate of 85%. It was planned to cover a sample of
10 000 people from 25 randomly selected rural
clusters. A computerised simple random sampling
approach was used to select 25 clusters from a sampling frame of 910 clusters generated from the
total rural population of 472 085 from 229 villages
of District Gurgaon.14 The study protocol received
ethical approval from the Institutional Ethics
Committee, All India Institute of Medical Sciences,
New Delhi in April 2010. Written informed
consent for enrolment and examination was
obtained from all adults for their own participation
and from parents or appropriate guardians of all
eligible children before they were included in the
study in accordance with the principles of the
Declaration of Helsinki.
A house-to-house visit was made to each family
in the selected village cluster. All eligible individuals
were examined by an experienced ophthalmologist
for the presence of corneal opacity using a portable
slit-lamp. Individuals detected with corneal
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opacication during the house-to-house examination were
invited for a detailed ocular examination at a temporary makeshift clinic utilising the local infrastructure of the village that
was easily accessible to the enumerated study population of the
concerned village. People who were bedbound or those who
failed to attend the central clinical facility in the village were
examined at home.
The comprehensive ocular examination of patients with
corneal opacity included visual acuity estimation with the
logMAR tumbling E chart for distance and near, noncycloplegic refraction and prescription (cycloplegic refraction
for children), non-contact tonometry, lens examination and cataract assessment by the Lens Opacity Classication System III, slit
lamp biomicroscopy with uorescein staining, and detailed
retinal evaluation. The corneal examination was performed
under high magnication and emphasis was laid on the aetiopathogenesis, morphological characteristics and management of
the corneal disease. In the present study, blindness was dened
as visual acuity <3/60 in the better eye with available
correction.
Quality assurance and standardisation of all study procedures
and equipments was maintained throughout the period of the
study. A single cornea specialist conducted the ophthalmic
examination on the entire study population. The items of ophthalmic equipment were calibrated and standardised at regular
intervals. Any potential observer or measurement bias was thus
reduced.
Statistical analysis
The data were entered into a specially designed Microsoft
Access based platform with inbuilt validation and consistency
checks. Data analysis was carried out using Stata V.12.0 (Stata,
College Station, Texas, USA). Qualitative data has been
described as number (%) and quantitative data has been
described as meanSD and median (range) as appropriate. The
multivariable logistic regression analysis was done to nd the
association between sociodemographic factors and the presence
RESULTS
The total enumerated population in the 25 clusters of Rural
Gurgaon was 12 899. Out of these, 12 113 individuals completed all the study procedures, with a coverage of 93.9%. The
synopsis of the study participants recruited at each step has been
summarised in gure 1.
Sociodemographic prole
The age and gender distribution of the enumerated and the
covered population was similar and it matched the national
demographic prole of the Indian population. Although 6.1%
of the sample population could not be covered, the enumerated
population and the covered population had comparable sociodemographic characteristics. Males comprised 51% of the study
population (table 1).
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Global issues
Table 1 Sociodemographic profile of the enumerated and covered
study population in rural Gurgaon
Sociodemographic parameters
Age (years)
015
1639
4059
60
Gender
Male
Female
Occupation
Housework
Agricultural work
Non-agricultural work
Indoor work
Not working
Students and children
Education profile
Illiterate
Primary education*
Schooling (Std. 612)
Graduate and above
Children <7 years
Marital status
Married
Unmarried
Divorced/separated/
widow/widower
Religion
Hindu
Muslim
Total
Enumerated
population
n=12 899
n
Covered
population
n=12 113
n (%)
Uncovered
population
n=786
n (%)
4194
5632
2041
1032
4000 (95.4)
5276 (93.7)
1840 (90.2)
997 (96.6)
194
356
201
35
(4.6)
(6.3)
(9.8)
(3.4)
6745
6154
6173 (91.5)
5940 (96.5)
572 (8.5)
214 (3.5)
3435
709
1337
1263
692
5463
3349 (97.5)
653 (92.1)
1162 (86.9)
1080 (85.5)
668 (96.5)
5201 (95.2)
86
56
175
183
24
262
(2.5)
(7.9)
(13.1)
(14.5)
(3.5)
(4.8)
1949
2267
6292
641
1750
1862 (95.5)
2143 (94.5)
5828 (92.6)
575 (89.7)
1705 (97.4)
87
124
464
66
45
(4.5)
(5.5)
(7.4)
(10.3)
(2.6)
6303
5968
628
5847 (92.8)
5674 (95.1)
592 (94.3)
456 (7.2)
294 (4.9)
36 (5.7)
12 726
173
12 899
11 951 (93.9)
162 (93.6)
12 113 (93.9)
775 (6.1)
11 (6.4)
786 (6.1)
DISCUSSION
The CORE study is the rst detailed, population-based study on
corneal diseases in the Indian population. To the best of our
knowledge, our study is the largest epidemiological study on
corneal opacities worldwide. This study provides reliable epidemiological data on the prevalence and risk factors of corneal
blindness and morbidity across all age groups in a rural North
Indian population.
In the present study, the prevalence of corneal opacity was
3.7% (95% CI 3.4% to 4.1%). There are a few published
studies on ocular morbidity conducted in the Indian population,
which report the prevalence rate of corneal opacity as 4.2% in
people aged 20 years and 3% in people aged 50 years.13 15
These studies involved a very small sample of the population
and hence do not represent accurate estimations of the prevalence of corneal opacity. In a hospital-based study in Haryana,
11.6% of patients with a visual acuity of 6/9 or worse were
found to have corneal disease.16 As these studies did not include
all age groups, they failed to provide comprehensive and representative data on the burden of corneal diseases in the general
population.
The prevalence of corneal blindness in this rural population
was 0.12%, and 0.45% of people were unilaterally blind due to
corneal disease. This amounts to a signicant burden on the
health system in general, and the blindness programme in particular. In another Indian study, the prevalence of corneal blindness (dened as presenting visual acuity <6/60 in the better eye
in this study) was reported to be 0.10% and that of unilateral
corneal blindness was 0.56%.17 A Chinese study also reported a
similar prevalence of corneal blindness of 0.1%.18
The common causes of corneal opacity in this rural population were pterygium (34.5%) followed by trauma (22.3%) and
infectious keratitis (14.9%). The aetiological factors responsible
for corneal disease were reported to be different in the late 19th
century, wherein trachoma was the most common corneal
disease reported (30%) in a hospital-based study.16 The impact
of community trachoma control programmes and nutritional
education together with a measles immunisation programme has
resulted in a reduction of the burden of corneal blindness due
to trachoma and vitamin A deciency.
The main aetiological diseases responsible for corneal blindness in our study population were post-surgical bullous keratopathy (46.2%), corneal degenerations (23.1%) and trachoma
(15.4%). In the South Indian population, corneal blindness was
predominantly due to infectious keratitis (59.5%) and trauma
(23.2%).17 Studies from Thailand and Gambia also report the
common causes of corneal blindness.19 20 In Thailand, these
were infections (35.6%), surgical bullous keratopathy (27.8%),
and trauma (14%).19 In Gambia, vitamin A deciency (7.8%)
was an important cause of corneal blindness in addition to
infectious keratitis (22.7%) and trauma (14.3%).20 Thus,
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150
Table 2
Effect of sociodemographic factors on the prevalence of corneal opacity by logistic regression analysis
Corneal opacity
No
n=11 661
Yes
n=452
Prevalence
% (95% CI)
3997
5247
1680
737
3
29
160
260
5966
5695
207
245
No
n=7664
Yes
n=449
Prevalence
% (95% CI)
1554
831
4715
564
271
63
105
10
3167
616
1118
1041
1722
182
37
44
39
147
5.43
5.67
3.79
3.61
7.87
Unadjusted OR
(95% CI)
p Value
p Value
1.0
7.36 (2.24 to 24.19)
126.89 (40.44 to 398.17)
470.02 (150.20 to 1470.83)
0.001
<0.001
<0.001
1.0
7.34 (2.23 to 24.11)
126.23 (40.22 to 396.14)
467.64 (149.42 to 1463.52)
0.001*
<0.001*
<0.001*
0.025*
1.0
1.24 (1.03 to 1.49)
0.025
1.0
1.07 (0.87 to 1.31)
0.533
p Value
Unadjusted OR
(95% CI)
p Value
p Value
<0.001*
1.0
0.43 (0.33 to 0.58)
0.13 (0.10 to 0.16)
0.10 (0.05 to 0.19)
<0.001
<0.001
<0.001
1.0
0.80 (0.58 to 1.10)
0.47 (0.34 to 0.64)
0.52 (0.25 to 1.06)
0.168
<0.001*
0.071
1.0
1.04 (0.72 to 1.50)
0.68 (0.49 to 0.96)
0.65 (0.46 to 0.93)
1.5 (1.19 to 1.86)
0.812
0.027
0.017
0.001
1.0
1.02
1.21
1.59
1.48
0.937
0.417
0.056
0.015*
p Value
<0.001*
Corneal opacity
Risk Factors
Education
Illiterate
Primary education
Schooling (Std. 612)
Graduate and above
Occupation
Housework
Agricultural work
Non-agricultural work
Indoor work
Not working and students
(4.67
(3.89
(2.69
(2.50
(6.64
to
to
to
to
to
6.20)
7.44)
4.89)
4.73)
9.09)
<0.001*
(0.63 to
(0.77 to
(0.99 to
(1.08 to
1.64)
1.88)
2.57)
2.03)
Risk Factors
Global issues
Table 3 Effect of sociodemographic factors on the prevalence of corneal blindness by logistic regression analysis
Corneal blind
Risk factors
Age (years)
<60
60
Gender
Male
Female
Education
Up to primary
Above primary (>Std. 5)
Occupation
Housework
Agricultural work
Non-agricultural work
Indoor work
Not working/retired
Students and children
No
(n=12 046)
Yes
(n=67)
Prevalence
% (95% CI)
11 093
953
23
44
p Value
p Value
p Value
1.0
22.27 (13.39 to 37.03)
<0.001*
1.0
4.70 (2.38 to 9.26)
<0.001*
1.0
1.64 (1.00 to 2.69)
0.048*
1.0
1.13 (0.58 to 2.19)
0.720
1.0
0.19 (0.10 to 0.36)
<0.001*
1.0
0.30 (0.15 to 0.62)
0.001*
1.0
0.41
0.69
0.25
6.47
0.03
0.224
0.416
0.057
<0.001*
<0.001*
1.0
0.58
1.38
0.73
2.81
0.04
0.505
0.584
0.679
0.003*
0.002*
<0.001*
0.046*
6147
5899
26
41
5655
6391
55
12
3324
651
1156
1078
637
5200
25
2
6
2
31
1
0.75
0.31
0.52
0.19
4.64
0.02
(0.45
(0.12
(0.10
(0.07
(3.04
(0.01
to
to
to
to
to
to
1.04)
0.73)
0.93)
0.44)
6.24)
0.06)
(0.10
(0.28
(0.06
(3.79
(0.01
to
to
to
to
to
1.73)
1.69)
1.04)
11.03)
0.19)
(0.12
(0.47
(0.15
(1.41
(0.01
to
to
to
to
to
2.75)
3.99)
3.53)
5.59)
0.32)
contrary to popular belief and previous studies,17 19 20 the predominant cause of corneal blindness in the current study was
not infectious keratitis but corneal decompensation following
cataract surgery. Addressing the issue of improving the quality
of cataract surgical services in the country will help reduce the
requirement for corneal transplantation. There is a need for
implementing monitoring mechanisms so that good quality cataract surgery is available at all levels of healthcare delivery,
thereby reducing the load of corneal complications after cataract
surgery.
The study highlights the changing trends in the pattern of
corneal diseases in the rural Indian population. The success of
prevention programmes related to keratomalacia and trachoma
have led to marked reductions in their prevalence, as exemplied in the present study. We need to be cautious about the
Table 4
Causes and age distribution of corneal opacities and corneal blindness in the study population (n=435)
Corneal pathology
People with CO
n=435
n (%)
Bilateral blind*
n=13
n (%)
Unilateral blind
n=54
n (%)
Pterygium associated CO
Traumatic CO
Infectious keratitis
Corneal dystrophy and degenerations
Trachomatous keratopathy
Aphakic/pseudophakic bullous keratopathy
Post-exanthematous CO
Iatrogenic CO
Vitamin A deficiency associated CO
Glaucoma with corneal decompensation
Miscellaneous
Unknown aetiology
55 (1895)
60 (1190)
65 (3094)
72.5 (5192)
68 (3299)
75 (6294)
65 (4282)
68 (6098)
45.5 (1458)
63.5 (6364)
65 (284)
62 (2274)
150 (34.5)
97 (22.3)
65 (14.9)
26 (6.0)
21 (4.8)
17 (3.9)
15 (3.5)
13 (3.0)
4 (0.9)
2 (0.5)
16 (3.8)
9 (2.1)
0
0
1
3
2
6
0
0
1
0
0
0
0 (0.0)
14 (25.9)
12 (22.2)
4 (7.4)
6 (11.1)
8 (14.8)
7 (13.0)
1 (1.9)
1 (1.9)
1 (1.9)
0 (0.0)
0 (0.0)
(0.0)
(0.0)
(7.7)
(23.1)
(15.4)
(46.2)
(0.0)
(0.0)
(7.7)
(0.0)
(0.0)
(0.0)
151
Global issues
study involved a large sample population which was larger than
any previously published study on corneal blindness, the sample
size was not adequate for ascertaining the true prevalence of
corneal blindness.17 18 However, the sample size was appropriate for assessing the primary objective of the study which was to
determine the population prevalence of corneal opacity.
The major strengths of this study are the high response rate
(93.9%) in a large sample population covering all age groups,
and that it is the rst reported population-based study, specically designed to study the prevalence of corneal opacity in
India, outlining all determinants and aetiological factors responsible for its occurrence. This study will prove useful in planning
blindness programme initiatives and estimating resources
required to provide comprehensive corneal services for the community, thereby helping to eliminate the causes of avoidable
corneal blindness and visual impairment.
Contributors NG: Literature search and compilation, study conception and design,
data collection and acquisition, data analysis and interpretation, drafting and writing
of manuscript. PV: Study conception and design, critical revision of manuscript,
administrative, technical and material support, supervision. RT: Study conception and
design, data interpretation, revision of manuscript for important intellectual content,
supervision. SKG: Study conception and design, data collection and acquisition,
revision of manuscript for important intellectual content, technical support. SD:
Statistical expertise, data analysis and interpretation, revision of manuscript for
important intellectual content. KM: Study design, statistical expertise, data analysis
and interpretation.
Competing interests None.
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REFERENCES
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doi: 10.1136/bjophthalmol-2014-305945
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Notes