Injury, Int. J.

Care Injured 44 (2013) 118–125

Contents lists available at SciVerse ScienceDirect

Injury
journal homepage: www.elsevier.com/locate/injury

Increasing compliance with protective eyewear to reduce ocular injuries in

stone-quarry workers in Tamil Nadu, India: A pragmatic, cluster randomised
trial of a single education session versus an enhanced education package
delivered over six months
James S.K. Adams a, Renu Raju a, Victor Solomon a, Prasanna Samuel b, Amit K. Dutta c,
Jeyanth S. Rose a, Prathap Tharyan d,*
a
Department of Ophthalmology, Christian Medical College, Vellore 632002, Tamil Nadu, India
b
Department of Biostatistics, Christian Medical College, Vellore 632002, Tamil Nadu, India
c
Department of Gastrointestinal Sciences, Christian Medical College, Vellore 632004, Tamil Nadu, India
d
South Asian Cochrane Centre, Prof. BV Moses & Indian Council for Medical Research Centre for Advanced Research and Training in Evidence-Informed Healthcare,
Carman Block II Floor, Christian Medical College, Vellore 632002, Tamil Nadu, India

A R T I C L E I N F O A B S T R A C T

Article history: Objective: To evaluate the efficacy of standard education versus enhanced education in increasing
Accepted 1 October 2011 compliance with protective eyewear to prevent ocular injuries in stone-quarry workers.
Design: Pragmatic, allocation concealed, participant and outcome assessor blinded, cluster randomised
Keywords: trial.
Intervention study Setting: Six stone-quarries around Vellore, Tamil Nadu, South India.
Cluster randomised trial Participants: 204 consenting adult stone quarry workers.
Eye injuries
Interventions: Protective eyewear plus enhanced education (one education session, plus 11 sessions of
Stone Quarry
group education, individual discussions, and educational plays over six months) versus protective
Occupational health
Occupational injury eyewear plus standard education (one education session and 5 follow up visits).
Eye protective devices Outcomes: The primary outcomes were observer-rated compliance with protective eyewear and
Safety glasses reduction in incidence of ocular injuries (slit-lamp examination by an observer blinded to allocation
Protective eyewear usage status) at three and six months. Analysis was by intention to treat.
Compliance Results: Quarries and participants were similar at enrolment. All quarries; 92/103 (90%) of workers in
three quarries given enhanced intervention, and 91/101 workers (89%) in three quarries given standard
education, completed six months follow up. Compared to standard education, enhanced education
significantly increased compliance with protective eyewear by 16% (95% CI 3–28%) at three months (OR
2.1; 95% CI 1.2–3.8); and by 25% (95% CI 11–35%) at six months (OR 2.7; 95% CI 1.5–4.8). Protective
eyewear and enhanced education reduced the incidence of eye injuries at three months by 16% (95% CI
7–24%); and standard education by 13% (95% CI 4–22%), compared to the three months before
interventions. The cumulative reduction over baseline in eye injuries at the six months was greater with
enhanced education (12% decrease; 95% CI 3–21%) than with standard education (7% decrease; 95% CI
17% decrease to 3% increase). However, this incidence did not differ significantly between intervention
arms at three months (OR 0.7% 95% CI 0.3–2.1); and at six months (OR 0.8; 95% CI 0.4–1.5).
Conclusion: Provision of appropriate protective eyewear reduces the incidence of eye injuries in stone-
quarry workers. Periodic educational and motivational sessions with individuals and groups facilitates
sustained use of protective eyewear.
ß 2011 Elsevier Ltd. All rights reserved.

Introduction

* Corresponding author. Tel.: +91 416 2284499; Mobile: +91 9443743851.
E-mail addresses: jamesadams@gmail.com (James S.K. Adams),
renuraju@hotmail.com (R. Raju), saralsolomon@yahoo.com (V. Solomon),
prasanna_samuel@hotmail.com (P. Samuel), akdutta1995@yahoo.co.in
(A.K. Dutta), jeyanthrose@hotmail.com (J.S. Rose), prathap@cmcvellore.ac.in
(P. Tharyan).
Ocular injury is an important preventable cause of blindness
and a global public health problem. It is estimated that 55 million
eye injuries occur each year that restrict activities for more than a
day; in about 1.6 million these injuries lead to blindness, with an
additional 2.3 million people developing bilateral low vision, and

0020–1383/$ – see front matter ß 2011 Elsevier Ltd. All rights reserved.
doi:10.1016/j.injury.2011.10.001

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 J.S.K. Adams et al. / Injury, Int. J. Care Injured 44 (2013) 118–125
an estimated 19 million developing unilateral blindness or low
vision.1 Ocular injury most often occurs in the workplace in low-
and middle-income countries, particularly in the construction,
agricultural, mining, and manufacturing industries. Environmental
factors; migrant labour; unorganised working conditions; lack of
implementation of regulations; lack of knowledge, availability, or
regular use of protective equipment such as safety goggles; and
delays in seeking appropriate treatment, lead to a high burden of
ocular trauma, high treatment-related and productivity-related
economic costs, and lower quality of life in affected people in these
countries.2–27
Occupations involving hammering, drilling, and the use of
pneumatic chisels are hazardous, where projectile chips of stone,
metal, and wood result in corneal lacerations and penetrating
ocular injuries.4,5,10,17,18,28 A particularly hazardous occupation in
relation to the potential for ocular injuries in India is stone-
quarrying. Quarry or mining workers are at significantly elevated
risk of multiple, non-fatal injuries than construction, or other,
workers.29 India has numerous stone quarries that cater to the
growing domestic and international construction industry. India is
a leading exporter to the EU and to other countries, of granite,
sandstone, marble, and other natural stones. Quarries in India
employ several hundreds of men and women workers mostly from
migrant, socio-economically disadvantaged sections, who are
vulnerable to ocular and other injuries. Whilst there are many
regulations governing mining and quarrying in India, their
enforcement is unsatisfactory, and quarry owners are not
mandated to provide safety equipment to their workers. Studies
on ocular injuries in stone quarry workers from India are scant,
though one hospital-based survey did document a high rate of eye
injuries in stone-crushers, amongst those with work-related eye-
injuries that required hospitalisation.29
We conducted a pilot study (un-published) from July to October
2005 in six granite quarries around Vellore town to document the
prevalence of work-related eye injuries and to evaluate the efficacy
and acceptability of protective eyewear amongst stone quarry
workers. Over the three months prior to the baseline survey, 15.1%
of 218 consenting adult workers (18–65 years) reported eye
injuries sufficiently severe for them to seek treatment, often from
private clinics; 10% of these were vision threatening. After
documenting and charting the injuries using a hand-held slit
lamp, we distributed plastic protective eyewear to all workers after
an educational session consisting of a health-education talk
stressing the importance of regular use of the protective eyewear,
and display of posters depicting ocular trauma due to stone
quarrying. At the end of three months, a repeat slit-lamp
examination documented that the incidence of fresh eye injuries
had reduced to 6% (13/218), and none were vision threatening.
Regular use of protective eyewear was monitored by a health
worker during surprise checks, and at three months 188/218
workers (86%) were regularly using them. Whilst workers
expressed the need for protective eyewear, they were dissatisfied
with the fogging and staining with sweat, a feeling of heaviness,
and easy development of scratches within two weeks in them,
leading to difficulty with vision and requiring their frequent
replacement. This pilot study demonstrated the acceptance of
protective eyewear amongst quarry owners and workers, and their
efficacy in reducing the incidence of eye trauma; but highlighted
the need for scratch-proof, impact-resistant, lightweight, afford-
able eyewear, and for follow up education and motivation to
encourage their sustained and regular use.
Evidence from published reports of interventions or strategies
to promote the use of protective eyewear during work has not
shown any particular strategy to be effective. A systematic review
of published and unpublished research till 1999 of the effective-
ness of interventions that were designed to prevent work-related
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119
eye injuries in the construction, manufacturing and agricultural
industries, reported that policy changes were effective in changing
behaviours and reducing eye injuries in the manufacturing
settings, either in conjunction with a broader programme focusing
on eye safety or by policy alone. However, this review found
limited scientific literature about the effectiveness of interventions
in preventing eye injuries and called for more well-designed
studies.30 A Cochrane systematic review evaluated the effective-
ness of educational interventions in preventing ocular injuries
from randomised controlled trials (RCTs) and controlled before and
after studies undertaken and reported till August 2008, and found
no reliable evidence from the five included studies that educational
interventions reduced ocular injuries. The authors stressed the
need for well-conducted RCTs, particularly from low- and middle-
income countries, and with longer periods of follow-up.31
In this report we describe a pragmatic, cluster randomised trial
that was designed to compare the effectiveness of an enhanced
educational package over standard education in increasing the
regular use of protective eyewear and in reducing the incidence of
eye injuries amongst quarry workers around Vellore, in the
southern state of Tamil Nadu, India. This study was approved by
the Institutional Review Board (Research & Ethics committees) of
the Christian Medical College, Vellore.
Participants and methods
Objectives
The primary objectives of this study were to compare two
strategies of education, one more intensive and sustained than the
other, in increasing compliance with the use of protective eyewear
amongst stone-quarry workers; and to evaluate whether partici-
pants allocated to either educational strategy differed in the
incidence of detected eye injuries three months and at six months
after commencement of the study, compared to the three-month
incidence of eye-injures before the study.
Design
We used a pragmatic, cluster randomised design where the
units of randomisation were stone-quarries. A cluster randomised
design was chosen to prevent contamination of the two types of
educational interventions between quarries. The design was
pragmatic in that we used few exclusion criteria, employed no
additional research staff for this study, and utilised outcomes that
were practical and relevant to real-world conditions. We were
guided in the design and reporting of this trial by the CONSORT
extension for cluster randomised trials.32
Inclusion and exclusion criteria
Selection and randomisation of quarries
Of the 152 registered stone (blue-metal) quarries in the district
of Vellore, in Tamil Nadu in 2006, 41 were situated around the
district headquarter town of Vellore. They ranged from small
quarries (employing around 10–20 workers), to larger quarries
(employing >30 workers) and their registered legal status was
often unclear. Quarries were eligible for inclusion if they employed
more than 30 workers aged 18–60 years, were situated within a
20 km radius of the district headquarters town of Vellore, and if the
quarry owners consented to participate in the study. Since there
are no accurate geographical maps or lists of these registered
quarries, we approached all quarries within a 20 km radius of
Vellore town to create a list of eligible quarries. Randomisation and
allocation of quarries to interventions was achieved using a simple,
computer-generated, randomisation sequence by a statistician
120 J.S.K. Adams et al. / Injury, Int. J. Care Injured 44 (2013) 118–125
(PS) who was not involved in the conduct of the study or assessing
outcomes. Of the 10 eligible quarries (excluding the six quarries in
our pilot study), six quarries were randomly allocated to
interventions (three in each arm).
Participants
Participants were quarry workers aged 18–60 years in the
selected quarries who did not use prescription glasses for a
refractive error or presbyopia whilst working, were willing to use
protective eyewear and to participate in the study, and undergo the
baseline, three and six months ocular examinations. Quarry
workers who joined the quarries after commencement of the
study were excluded from the study though they were offered
protective eyewear and education on their use as provided to that
quarry. Formal informed consent to participate in the study was
obtained in the vernacular from the stone quarry owners and from
each quarry worker. Details of the educational interventions
randomised were not provided to participants in order to preserve
blinding of allocated interventions.
Interventions and comparisons
This study was conducted between September 2006 and March
2007. All study participants were provided scratch-proof, impact-
resistant, heat-toughened protective eyewear with side shields,
which they were instructed to wear regularly during work. If
needed, this protective eyewear was replaced at any point during
the study period, from stocks left with the quarry supervisors for
this purpose.
Standard education
The initial health education was common for the standard and
the enhanced education arms, and consisted of a health education
talk by health educators; display and discussion of posters showing
various minor and major ocular injuries and their consequences;
and instructions regarding the care, handling and usage of
protective eyewear. This occurred in a single session lasting
between 1–2 h, where opportunities were provided for clarifica-
tions. Participants in the standard education arm were followed up
twice in the first month, once in the second and third month and at
the end of six months to replace protective eyewear, collect reports
on regular compliance with protective eyewear, answer any
clarifications on their use from workers, and assess outcomes (five
follow-up visits).
Enhanced education
The enhanced education package consisted of the initial
standard education session at the time of dispensing the protective
eyewear, and additional education in the form of pre-recorded,
short street-plays and messages, regarding the need to prevent
ocular injury by the regular use of protective eyewear; group
motivational sessions; and individual counselling provided by
health workers to those who were not regularly using protective
eyewear. These sessions occurred over 1–2 h every week in the
first month, twice in the second and third month, and once a month
in the fourth, fifth and sixth months (11 educational sessions), at
which data were also collected on outcomes, as with the standard
education arm.
Outcomes
We selected two primary outcomes: one assessed compliance
with protective eyewear over the three and six-month period, and
the other assessed the incidence of eye injuries detected by slit
lamp examinations between intervention arms at three and six
months, and the reduction in the incidence of eye injuries at these
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time points compared to the baseline eye injury rate in the three
months preceding the study.
Compliance with protective eyewear
This was assessed in two ways. We selected one worker from
each quarry, who volunteered to help implement the regular use of
protective eyewear, to record and report to the study team the
quarry workers who regularly defaulted in wearing protective
eyewear whilst working in the quarry. In addition, a health worker
and the study team made surprise visits and recorded non-
compliance.
Incidence of eye injuries
At the baseline assessment an ophthalmologist (JSKA) collected
data from each worker in all quarries regarding any past eye
injuries, and specifically injuries in the previous three months that
caused enough discomfort to the individual to seek treatment; the
nature and details of the injuries, and their relation to the workers
activities at the time of injury. The three-month incidence was
selected in order to minimise recall bias. Vision was checked
unaided, and with a pinhole using a Snellen ‘E’ chart, in the quarries
under available conditions, to get a rough estimate of the visual
status of the individuals. We categorised vision into six grades as
per the World Health Organization, 1992 system (International
Statistical Classification of Diseases and related health problems,
Tenth revision). Refraction was not included as part of the protocol.
The ophthalmologist conducted ocular examinations with the
help of a torch and a portable, hand-held slit-lamp, of all the quarry
workers for evidence of old and fresh injuries, foreign bodies in the
conjunctiva and on the cornea. The injuries were charted and the
charts were locked away and not referred to till the end of the trial.
At three months and at six months, another ophthalmologist
(JSR), who was blind to the allocated interventions and not
involved in their administration, repeated the slit-lamp examina-
tions and charting of injuries on all workers remaining in the study
at these time points. The incidence of new eye injuries was arrived
at by consulting both sets of injury charts of each worker, through
worker self-reports, and through consensus amongst the three
ophthalmologists in the study (JSKA, RR, and JSR).
The secondary outcomes recorded were drop-outs in both
intervention arms, particularly due to injuries, and the reasons
expressed by workers about non-compliance with protective
eyewear that were obtained by health workers through open-
ended questions and through discussions.
Sample size calculation
We estimated sample size accounting for the intra-cluster
correlation coefficient. The intra-cluster coefficient in our pilot
study was 0.04. We estimated that a total sample size of 180 from
6 quarries would have a power of 85% to detect a difference of 15%
in compliance rates with protective eyewear between the
standard and enhanced education arms with an alpha error of
5%. Additionally if the baseline injury rate was assumed to be 15%,
and the injury rate was 6% for the standard intervention, as in our
pilot study, and 0% for the enhanced intervention, we estimated
that 180 workers would be required. We recruited 204 workers
from the six randomised quarries, to accommodate potential
drop-outs.
Data analysis
Continuous variables were summarised using mean and
standard deviation; categorical variables were described using
 J.S.K. Adams et al. / Injury, Int. J. Care Injured 44 (2013) 118–125 121

frequencies and percentages. Odds ratios with 95% confidence Eligible Stone Quarries = 16
intervals (CI) were calculated for differences in compliance rates
Excluded = 10

Enrolment
and incidence of injuries between intervention arms. We
4 quarries with number
estimated the absolute difference in the percentage change (with of workers < 30
their 95% CI) for these estimates and for the incidence of eye Randomised 6 quarries from the pilot
injuries in the first three months after interventions, as well as the 6 stone quarries study
percentage change in the cumulative incidence of eye injuries at
six months, compared with the baseline incidence rate over the
three months prior to the study. Analysis was conducted at the
level of quarry workers, and the intra-cluster correlation coeffi- Enhanced education Standard education
cient (ICC) was calculated for the primary outcomes. The ICC was Quarries = 3 Quarries = 3

Allocation
0.02 for the incidence of eye injuries and 0 for compliance with Quarry Size = 35, 35, 33 Quarry size = 34, 33, 34
Workers = 103 Workers = 101
protective eyewear, and, in consultation with statistical experts in
cluster randomised trials, we concluded that these were negligible Workers excluded = 1 Workers excluded = 0
and therefore present unadjusted effect estimates. (Wearing prescription
glasses)
Analysis involved all workers present at the three- and six-month
follow-up, but two additional analyses were done using intention to
treat principles. In one analysis, all drop outs were assumed to have

Follow up at 3 months
Quarries = 3 Quarries = 3
been compliant with eyewear and not injured for all workers Quarry size = 33, 34, 32 Quarry size = 34, 31, 32
randomised (best case scenario), whilst in the conservative worst Workers = 99 Workers = 97
case scenario, since workers who had left the quarries were assumed
Lost to follow up Lost to follow up
to be not wearing protective eyewear, and fresh eye injuries had not
Quarries = 0 Quarries = 0
been ruled out objectively, all workers lost to follow up were Workers = 4 Workers = 4; (Left area
assessed as not compliant with eyewear, and as having fresh eye (Left area = 4) = 3; Joined another
injuries. Since the primary outcome was reduction in detected eye quarry = 1)
injuries between baseline and at the endpoints, only data from those
who had an endpoint evaluation by slit-lamp were utilised. We Quarries = 3 Quarries = 3
Quarry size = 31, 31, 30 Quarry size = 33, 29, 29
Follow up at 6 months

present the results of all analyses.

Workers = 92 Workers = 91

Results Lost to follow up Lost to follow up

Fig. 1 depicts the flow of workers in the six quarries through
selection, allocation and at three and six months. We randomised
204 quarry workers comprising of 103 workers in three quarries
randomly allocated to enhanced education and 101 workers in
three quarries randomly allocated to standard education. Overall
92/103 workers in the enhanced education arm and 91/101 in
standard education arm completed all assessments till six months
after commencement. None of the clusters (quarries) dropped out.
Proportions of participants lost to follow up in the enhanced
education arm over six months (10.7%) and in the standard
education arm (9.9%) did not differ significantly and none of these
workers were reported to have been injured or been non-
compliant with protective eyewear before they were lost to
follow-up or dropped out from the trial.
Table 1 describes the demographic profiles, work character-
istics at recruitment; and eye injuries in the three months
preceding recruitment, in the enhanced and the standard
education arms. Males outnumbered females, and the average
work experience was around 15 years, with most male workers in
both arms engaged in cutting large stones. No significant
differences were noted in these characteristics between interven-
tion arms at baseline.
Compliance with protective eyewear
Table 2 details the compliance rates with protective eyewear.
Compared to standard education, enhanced education significantly
increased compliance with protective eyewear by 16% (95% CI 3–
28%) at three months (OR 2.1; 95% CI 1.2–3.8); and by 25% (95% CI
11–35%) at six months (OR 2.7; 95% CI 1.5–4.8).
Incidence of eye injuries
At baseline, 80/103 (78%) in the arm given enhanced education
and 88/101 (87%) given standard education reported eye injuries at
Quarries = 0 Quarries = 0
Workers = 7 Workers = 6
(Joined other quarries = (Joined other quarries =
6; died in road traffic 4; left area = 1)
accident = 1)
Lost over 6 months = Lost over 6 months =
11/ 103 (11%) 10/ 101 (10%)
Fig. 1. Flow chart of clusters and participants through the phases of the study.
some time in the past. The three-month incidence of eye injuries
prior to the intervention was 18.4% (19/103) in the enhanced
education arm and 17.8% (18/101) in the standard education arm.
Seven (3.4%) workers (3 in the enhanced group and 4 in the
standard group) had suffered serious injury to an eye whilst
cutting stones. Of the seven, vision was less than 1/60 to perception
of light in five, and in two, vision was less than 6/60 in one and 3/60
in the other. One worker had suffered a corneal tear, traumatic
cataract, intraocular foreign body, and retinal detachment that
required surgery. Another worker gave a history of corneal tear
suturing and intraocular foreign body removal. Two had traumatic
cataract, and three others with a history of corneal tear suturing
were noted to have corneal scars causing decreased vision.
Protective eyewear and enhanced education reduced the
incidence of eye injuries at three months by 16% (95% CI 7–
24%); and standard education by 13% (95% CI 4–22%), compared to
the three months before interventions (Table 3). The cumulative
reduction over baseline in eye injuries over the six months of the
trial was greater with enhanced education (12% decrease; 95% CI
3–21%) than with standard education (7% decrease; 95% CI 17%
decrease to 3% increase). However, the difference in the incidence
of eye injuries were not statistically significant between interven-
tion arms at three months (OR 0.7% 95% CI 0.3–2.1); and at six
months (OR 0.8; 95% CI 0.4–1.5).
Of the 18 workers in intervention arms with new ocular injuries
over the six months (7 in the enhanced education arm; 11 in the

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Table 1
Baseline characteristics of the quarries and study participants.

Characteristics Enhanced education Standard education

Quarries
Number of quarries 3 3
Number of workers 35, 35, 33 34, 33, 34

Participants Number = 103 Number = 101

Mean age (SD) 38.7 (10.4) 39.3 (10.6)

Number female (%) 24 (23.3) 22 (21.8)
Number literate (%) 49 (47.6) 44 (43.6)
Number with income < 1000 rupees (140 pounds)/month (%) 26 (25.2) 16 (15.8)
Mean years of work (SD) 14.4 (9.3) 14.5 (9.1)
Number involved in cutting large stones (%) 84 (81.6) 82 (81.2)
Number with eye injuries in three months prior to intervention (%) 19 (18.4) 18 (17.8)
Number with a family member working in the quarry (%) 80 (87.7) 72 (81.3)
Number with a family history of ocular trauma (%) 59 (57.3) 54 (53.5)

Table 2
Compliance with protective eyewear at three and six months in stone-quarry workers given enhanced versus standard education.

Compliance with protective eyewear Enhanced education Standard education Odds Ratio (95% CI)a Absolute change % (95% CI)
Quarries = 3 Quarries = 3
Participants = 103 (%) Participants = 101 (%)

At three months
In those remaining 90/99 (90.9) 80/97 (82.5) 2.1 (0. 9–5.0) +8 ( 1 to +18)
In all randomised (Best case) 90/103 (87.3) 80/101 (79.2) 1.8 (0.9–3.9) +8 ( 2 to +18)
In all randomised (Worst case) 77/103 (74.7) 59/101 (58.4) 2.1 (1.2–3.8) +16 (+3 to +28)
At six months
In those remaining 83/92 (90.2) 69/91 (75.8) 2.9 (1.3–6.8) +14 (+3 to +25)
In all randomised (Best case) 83/103 (80.6) 69/101 (68.3) 1.9 (1.0–3.7) +12 (+0 to +23)
In all randomised (Worst case) 63/103 (61.2) 37/101 (36.6) 2.7 (1.5–4.8) +25 (+11 to +35)
a
Intra-cluster correlation coefficient (ICC) = 0; CI, confidence interval.

standard education arm), 13 had corneal scars (non-linear and
linear) at baseline; at the end of six months, eight new scars were
identified. Out of the eight, five were non-linear scars and three
were linear scars; none were vision-threatening.
Satisfaction with protective eyewear
Unlike in our pilot study, only 30/24 (15%) of workers required a
change in eyewear due to scratches, staining or breakage, and the
protective eyewear that was specially designed for this study
through a local commercial source was found to be quite durable.
Each pair cost around 50 Indian rupees (<1 GB pound). According
to the workers surveyed, the cost of seeking treatment for an eye
injury ranged from 500 to 5000 Indian rupees (7–70 GB pounds).
The reasons given for not wearing protective eyewear included
discomfort caused by the side-shields pressing on the orbital rim;
dissatisfaction with the size of eyewear provided; not perceived as
fashionable; and beliefs that since they had not been injured in the
past, they did not need protection. Workers not regularly
compliant with protective eyewear and those with new eye

Table 3
Incidence of eye injuries and reduction in the incidence at three and six months compared to baseline incidence in stone-quarry workers provided enhanced versus standard
education.

Eye injuries Enhanced education Standard education Odds Ratio (95% CI)a Absolute change % (95% CI)
Quarries = 3 Quarries = 3
Participants = 103 (%) Participants = 101 (%)

At three months
In those remaining 3/99 (3.0) 5/97 (5.1) 0.6 (0.1–2.5) 2 ( 9 to +4)
In all randomised (Best case) 3/103 (2.9) 5/101 (4.9) 0.6 (0.1–2.5) 2 ( 9 to +4)
In all randomised (Worst case) 7/103 (6.8) 9/101 (8.9) 0.7 (0.3–2.1) 2 ( 10 to +6)
At the end of six months
In those remaining 7/92 (7.6) 11/91 (12.0) 0.6 (0.2–1.6) 4 ( 13 to +4)
In all randomised (Best case) 7/103 (6.8) 11/101 (10.9) 0.6 (0.2–1.6) 4 ( 12 to +4)
In all randomised (Worst case) 17/103 (16.5) 21/101 (20.8) 0.8 (0.4–1.5) 4 ( 15 to +6)
Reduction in eye injuries compared to three months before interventions (baseline)
Baseline 19/103 (18.5) 18/101 (17.8) 1.1 (0.5–2.1)
Reduction in incidence at three months
In all randomised to enhanced education 16/103 (15.5) 0.1 (0.0–0.5) 16 ( 7 to 24)
In all randomised to standard education 13/101 (12.8) 0.2 (0.1–0.7) 13 ( 4 to 22)
In all randomised 16/103 (15.5) 13/101 (12.8) 1.3 (0.6–2.7) 3 ( 7 to +12)
Reduction in incidence at six months
In all randomised to enhanced education 12/103 (11.6) 0.3 (0.1–0.8) 12( 3 to 21)
In all randomised to standard education 7/101 (6.9) 0.6 (0.3–1.3) 7 ( 17 to +3)
In all randomised 12/103 (11.7) 7/101 (6.9) 1.8 (0.7–4.7) 5 ( 4 to +1)
a
Intra-cluster correlation coefficient (ICC) = 0.02; CI = confidence interval.

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 J.S.K. Adams et al. / Injury, Int. J. Care Injured 44 (2013) 118–125
injuries did not differ significantly from those regularly compliant,
or those with no new eye injuries over the six months, on any
demographic or work related variable.
Drop-outs
The commonest reason for dropping out of this study that could
be ascertained was migration to other quarries, and none were
reported to have dropped out due to eye injuries. The proportions
that dropped out did not differ significantly between intervention
arms.
Discussion
Quarry workers, particularly in India, are a group of people who
are especially exposed to the risk of ocular trauma by the nature of
work; they also face a host of other physical illnesses and social
problems. These problems are compounded by the lack of
organised health care facilities and physical amenities at their
places of work. Indian data on the prevalence of ocular injuries
amongst quarry workers is scant and we found no published study
from India or elsewhere of any preventive interventions in this
group of disadvantaged workers.
This study demonstrates that: (a) protective eyewear designed
to suit the harsh working conditions in these quarries are accepted
and welcomed by quarry workers; (b) their regular use reduces the
incidence of ocular trauma, and prevents vision threatening
injuries; and (c) continued compliance with protective eyewear
amongst stone quarry workers is improved by an enhanced
educational programme that is sustained over longer periods than
just one educational session.
All quarry owners were welcoming of this intervention,
possibly since the interventions were provided at no cost to them,
and were seen to potentially increase productivity and job
retention; the quarry supervisors also endorsed the use of
protective eyewear and provided replacements, as instructed, to
workers when needed. The legal status of the quarries randomised
in this intervention was unclear and the quarry owners were
elusive about such details. More than half the workers were
illiterate; explained by the fact that many members of the same
families work in quarries, and their children take up quarry work at
an early age to add to the family income, rather than go to school.
Hence educational interventions were designed to address this
lack of literacy and used locally appropriate media such as street
plays that are commonly used to communicate health messages.
Whilst many community-led initiatives attempt to address the
problem of children employed in quarries in India, none of the
quarries used in this study reported that they employ children; and
none of our participants were below the age of 18 years. There
were children seen in some quarries and addressing their health
needs in interventions such as ours is made difficult by their refusal
to be identified by owners, the workers, themselves, or their
families as working in these quarries.
Protective eyewear made of polycarbonate lenses would
provide better protection from projectile injuries at close range
than heat-treated lenses33 but their considerably higher costs
preclude their use in large scale interventions with quarry workers.
Comparison with other published studies in low and middle income
countries and high income countries
Comparison of the results of this study with other randomised
interventions is difficult since the two randomised trials identified
by the Cochrane review31 were conducted in school children34 or
male squash players35 and did not assess the incidence of eye
injuries. Both trials were judged not to be free of the risk of bias due
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123
to unclear reporting of random sequence generation, allocation
concealment, and blinding. The three other studies in the review
were controlled before and after studies, of which two reported
self-reported data on the incidence of eye injuries, though no
objective evaluations were done. One involved ship-fitters in the
US and trained their supervisors in 5–10 h of classroom training
over a period of one week. Incentives such as praising workers who
wore safety glasses were used to help the ship-fitters modify their
behaviour.36 No statistically significant differences in injury rates
were seen after the intervention; and no information on
compliance with safety glasses was provided. The second study
used community health workers to train migrant farm workers in
the US, who had at least two training sessions that included
enlarged photographs, presentations, and other written materials
that demonstrated eye injuries and hazards; two other groups of
workers had no safety training but were provided information
sheets on preventing injuries. Each farm worker in the three groups
was also provided safety glasses.37 This study did not report injury
rates but noted that the self-reported and observed use of safety
glasses had improved significantly over the 4–12 weeks of follow
up in the group that received the community health worker’s
education compared to the two groups that did not receive the
community worker’s educational intervention. Both studies were
judged by be at high risk of bias due to methodological limitations.
A search of the Cochrane Central Register of Controlled Clinical
Trials (CENTRAL) in Issue 8, 2011 of The Cochrane Library and of
PubMed in August 2011, using the terms ‘eye’ AND ‘injury’, did not
reveal any other trials of interventions to reduce the incidence of
eye injuries. A search via the WHO International Clinical Trials
Registry Platform’s search portal (http://apps.who.int/trialsearch/
default.aspx) also did not identify any relevant ongoing trials. Thus,
whilst occupational eye injuries continue to pose a global public
health problem, scientific evaluation of interventions aimed at
their prevention appear to be a low priority worldwide.
Strengths of this study
To the best of our knowledge, this is the first study conducted in a
low-income country to focus on the prevalence of ocular injury in
this vulnerable population of stone-quarry workers and to design
and evaluate an intervention to prevent this. The conclusions of the
Cochrane systematic review31 justified the need for this trial. The
pilot study provided useful information to design better protective
eyewear and to estimate sample sizes for the intervention. The
pragmatic nature of the intervention permits generalisation to other
quarries in India. This cluster randomised trial32 was designed
according to CONSORT guidelines for cluster randomised trials and
attempted to adjust for clustering effects, which were negligible. The
internal validity of the trial was ensured by randomisation to
balance confounders; concealment of allocation to the intervention
arms to prevent selection bias; and blinding of participants and
outcome assessors, and the use of objective determinations of
primary outcomes to prevent performance and detection biases. We
restricted eye-injury incidence to the three-month period before the
intervention and assessed eye injuries over two successive three-
month periods in order to minimise recall bias. We used intention to
treat principles in analyses to prevent reporting biases. Though
economic outcomes were not a specific focus of this study, the
interventions described in this report are likely to be more cost-
effective than treating eye injuries.
Limitations of the study
The main limitation of the study was the relatively short
duration of follow up of six months, though this was longer than
any controlled intervention reported to date in promoting the use
124 J.S.K. Adams et al. / Injury, Int. J. Care Injured 44 (2013) 118–125
of protective eyewear to prevent occupational ocular injuries. A
longer duration of follow up would help determine the long term
acceptability of protective eyewear, the frequency with which they
need to be replaced, and the optimal follow-up educational
sessions required to ensure the continued effectiveness of this
strategy in preventing ocular injuries in stone-quarry workers.
The reduction in the incidence of eye injuries at three and six
months between the interventions arms was not statistically
significant, though the point estimates favoured enhanced
education over standard education. The eye-injury rates used for
calculation of the estimated sample size and derived from our pilot
study differed from the rates actually observed between inter-
ventions in the randomised study. A sample size of over 8000
people in each arm would be required to demonstrate a
statistically significant difference in the reduction in injury rates,
if the actual differences observed with the interventions were used
to estimate the required sample size.
This trial only randomised six of the numerous quarries that
exist in the area. Quarry workers migrate in search of work to other
quarries and rarely leave their occupation, in spite of injuries. From
a public health perspective, interventions would need to cover all
stone-quarries to effectively reduce the risk of eye injuries to
quarry workers, and this intervention would need to be replicated
to include a larger number of quarries to assess its feasibility on a
larger scale.
Protective eyewear were provided free of cost to quarry
workers in this study and replaced free of cost, when required.
Future interventions would need to consider other financing
options such as encouraging quarry owners or employers to
subsidise their cost or provide them free of cost to their workers,
thorough effective social marketing strategies or through legisla-
tion. A more practical option may be to convince workers to invest
in the relatively small cost of protective eyewear compared to the
costs of treating ocular injuries.
Conclusions
Providing protective eyewear along with education reduces the
incidence of ocular trauma in stone-quarry workers. Mandatory
provision of protective eyewear by owners of quarries or
employers to their quarry workers and encouraging their continual
use will ensure significant reductions in ocular injuries in these
vulnerable people. Even if mandated by legislation, the results of
this trial indicate that periodic educational and motivational
sessions with individual and groups would be needed to facilitate
the continued use of protective eyewear, in order to sustain the
reductions in the incidence of ocular injury.
Contributions
JSKA and RR conceived the study and, with PT, designed and
wrote the trial protocol. JSR, VS, and AKD helped design the
protocol. JSKA, VS, and JSR conducted the trial, as detailed in this
report, under the supervision of RR. PS provided statistical
expertise, helped design the study, analysed and helped interpret
the data and write the draft report. JSKA wrote the initial draught of
the report and AKD helped revise the draught of the report. PT
conducted additional analyses, and wrote the final version of the
report. All authors provided critical input of the report and
approved the final version of the submitted manuscript.
Guarantors
RR had access to all study data and takes responsibility for the
integrity of data collection. PT takes responsibility for the accuracy
of data analysis.
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Conflicts of interest statement
All authors declare no competing academic or financial conflicts
of interest that bear on the design, conduct or reporting of this trial.
Ethics
This trial was approved by the Institutional Review Board
(Research and Ethics committees) of the Christian Medical College,
Vellore.
Funding source
This trial was funded by an intra-mural research grant from the
Fluid Research Fund of the Christian Medical College, Vellore,
administered through the Office of Research. Protective eyewear
was funded by a project grant from the Christoffel-Blindenmission
(CBM) to the Department of Ophthalmology, Christian Medical
College, Vellore. The funding sources had no role in the design,
conduct, or reporting of this trial.
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