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Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) and Opinion of Contact Lens Performance

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Purpose: To report on the development and validation of a short form of the Contact Lens Dry Eye Questionnaire (the CLDEQ-8) to enable it to reflect status of and change in overall opinion ("opinion") of soft contact lenses (SCLs). Methods: Item reduction for the CLDEQ was achieved by correlation with overall opinion of SCLs at follow-up visits in a sample of 38 SCL wearers at one academic clinical site. The CLDEQ-8 score (frequency plus late day intensity of dryness, discomfort, and "blurry vision"; frequency of "closing eyes to rest them" and "removing CLs to relieve discomfort") was then tested in 379 SCL wearers in a multicenter study with analysis stratified by opinion ratings at baseline and 2 weeks postrandomization to new silicone hydrogel SCLs. The sum of CLDEQ-8 scores (maximum 37) was correlated with opinion by Spearman's rank correlation coefficient and analyzed for change in opinion by analysis of variance (ANOVA). Results: The CLDEQ-8 scores in the validation sample were highly correlated with habitual baseline opinion (-0.44, p < 0.0001) and responsive to change in opinion postrandomization (-0.58, p < 0.0001). Baseline CLDEQ-8 scores by opinion status were as follows: Fair: 17.4 ± 8.7, Good 13.7 ± 6.4, Very Good 9.1 ± 4.7, and Excellent 6.4 ± 3.7 (ANOVA, F = 291.1, p < 0.0001). After 2 weeks, change in CLDEQ-8 scores by improvement status was as follows: Much Improved: -16.7 ± 10.0, Unchanged: -2.3 ± 5.0, to Much Worse +8.5 ± 5.8 (ANOVA, F = 16.5, p < 0.001). Conclusions: The CLDEQ-8 score significantly reflected baseline status and change in overall opinion after refitting with two types of silicone hydrogels. The CLDEQ-8 score is a valid outcome measure in SCL clinical trials to reflect opinion of SCLs.
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FEATURE ARTICLE ON LINE
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
and Opinion of Contact Lens Performance
Robin L. Chalmers*, Carolyn G. Begley
, Kurt Moody*, and Sheila B. Hickson-Curran
ABSTRACT
Purpose. To report on the development and validation of a short form of the Contact Lens Dry Eye Questionnaire (the
CLDEQ-8) to enable it to reflect status of and change in overall opinion (“opinion”) of soft contact lenses (SCLs).
Methods. Item reduction for the CLDEQ was achieved by correlation with overall opinion of SCLs at follow-up visits in a
sample of 38 SCL wearers at one academic clinical site. The CLDEQ-8 score (frequency plus late day intensity of dryness,
discomfort, and “blurry vision”; frequency of “closing eyes to rest them” and “removing CLs to relieve discomfort”) was then
tested in 379 SCL wearers in a multicenter study with analysis stratified by opinion ratings at baseline and 2 weeks
postrandomization to new silicone hydrogel SCLs. The sum of CLDEQ-8 scores (maximum 37) was correlated with opinion by
Spearman’s rank correlation coefficient and analyzed for change in opinion by analysis of variance (ANOVA).
Results. The CLDEQ-8 scores in the validation sample were highly correlated with habitual baseline opinion (0.44, p
0.0001) and responsive to change in opinion postrandomization (0.58, p 0.0001). Baseline CLDEQ-8 scores by
opinion status were as follows: Fair: 17.4 8.7, Good 13.7 6.4, Very Good 9.1 4.7, and Excellent 6.4 3.7
(ANOVA, F 291.1, p 0.0001). After 2 weeks, change in CLDEQ-8 scores by improvement status was as follows:
Much Improved: 16.7 10.0, Unchanged: 2.3 5.0, to Much Worse 8.5 5.8 (ANOVA, F 16.5, p 0.001).
Conclusions. The CLDEQ-8 score significantly reflected baseline status and change in overall opinion after refitting with
two types of silicone hydrogels. The CLDEQ-8 score is a valid outcome measure in SCL clinical trials to reflect opinion
of SCLs.
(Optom Vis Sci 2012;89:1435–1442)
Key Words: soft contact lens, symptoms, dryness, questionnaire, Contact Lens Dry Eye Questionnaire, CLDEQ
Although soft contact lenses (SCLs) have changed significantly
over the past 10 years with the introduction of silicone hydro-
gel materials and newer designs, discontinuation of wear
remains an important factor that limits the number of successful wear-
ers.
1,2
Ocular surface symptoms such as discomfort and dryness are
most often reported as the chief cause of discontinuation for both
hydrogel and silicone hydrogel lenses.
2–4
In a cross-sectional survey of
patients presenting for eyecare,
4
40% of former SCL wearers cited
dryness as their primary reason to discontinue use of lenses, and this
ranking has been confirmed in other recent studies.
2
Dryness and discomfort with SCL use are very common. The
prevalence of discomfort and dryness symptoms among SCL wear-
ers is high, approximately 50%, which is at least double than that
reported by subjects of similar age who were not using contact
lenses.
4,5
Even though so many SCL wearers report dryness and
discomfort, there is no established level of symptoms that is con-
sidered clinically significant. Definitive diagnosis of SCL-related
dryness remains a significant challenge, in part, because it is not a
disease, per se, but is a symptomatic condition that is amenable to
changes in SCL material
6–8
or lens care products
9,10
that can ame-
liorate symptoms. Finally, the SCL wearer may choose to cease lens
wear altogether as a remedy for dryness symptoms.
4
Recently the report from the 2007 Dry Eye Workshop included
contact lens-related dry eye in the evaporative category.
11
Soft
contact lens wear is associated with reversible changes in corneal
and conjunctival sensitivity and inflammation that may impact
dryness symptoms.
12–15
The potential to reverse SCL-related dryness
creates a considerable need for a well-designed validated questionnaire
for SCL-related dryness that is capable not only of assisting in diag-
nosis but also in measuring change in the condition that can be
improved by available treatments. A number of questionnaires
exist, but have not been validated so that the user knows the clinical
*OD, FAAO
OD, MS, FAAO
BSc(Hons), MCOptom, FAAO
Clinical Trial Consultant, Atlanta, Georgia (RLC), Indiana University School
of Optometry, Bloomington, Indiana (CGB), and Johnson & Johnson Vision
Care, Inc., Jacksonville, Florida (KM, SBH-C).
1040-5488/12/8910-1435/0 VOL. 89, NO. 10, PP. 1435–1442
OPTOMETRY AND VISION SCIENCE
Copyright © 2012 American Academy of Optometry
Optometry and Vision Science, Vol. 89, No. 10, October 2012
meaning of scores or change in scores. A valid questionnaire should
be able to identify SCL wearers who are struggling with clinically
significant SCL-related dry eye complaints
16
and be sensitive
enough to track their progress when treated with products de-
signed to reduce those symptoms.
17,18
The Contact Lens Dry Eye Questionnaire (CLDEQ) was devel-
oped more than a decade ago to measure dryness symptoms among
contact lens wearers.
19,20
The CLDEQ instrument was originally
designed in parallel to the Dry Eye Questionnaire (DEQ) for use in
patients who do not wear contact lenses. The long forms of both
the CLDEQ and DEQ instruments query contact lens-wearing
history, frequency and diurnal intensity, and intrusiveness of nine
ocular surface symptoms, along with questions about treatments,
computer use, and environmental triggers. Recently, a validated
five-item short form of the Dry Eye Questionnaire, the DEQ-5,
was developed for patients who do not wear contact lenses.
21
The
DEQ-5 instrument uses a scoring system that is anchored by the
patient’s self-assessment of dry eye severity and contains five items.
The purpose of this study was to develop and validate a short
version of the CLDEQ for SCL wearers by identifying a set of
questions that reflected satisfaction and overall opinion of SCLs
that was also responsive to change among wearers of modern SCL
materials.
METHODS
The development of the short form of the CLDEQ was conducted
in two phases. Both phases of this clinical research were conducted
after institutional review board approval. All subjects signed informed
consent before enrollment, and the studies were conducted in com-
pliance with the Declaration of Helsinki and local Health Insurance
Portability and Accountability Act guidelines.
This study took place in two phases, an item reduction phase and
aknown groups validity phase. Table 1 shows the lenses used in each
phase of the research, although results were analyzed and displayed
regardless of lens type. Subjects in both phases were included if
they were at least 18 years old, if they needed bilateral correction,
were in good general health, were willing and able to follow
instructions, and were a current full-time and adapted wearer of
SCLs. Subjects were not enrolled into the study if they were
using monovision correction, were wearing rigid gas-permeable
lenses, had clinically significant (grade 3 or 4) anterior segment
abnormalities (or any iritis or any infection of the eye, lids, or
adnexa), had ocular or systemic disease that would preclude SCL
wear, or best-corrected Snellen visual acuity of 20/30 in either
eye, or were pregnant or lactating females.
Item Reduction Phase
The purpose of the item reduction phase was to determine
which symptoms and SCL-wearer coping mechanisms most highly
correlated with the subjects’ overall opinion of the SCLs at all study
visits. This step was completed with data from a small study sample
at the Indiana University School of Optometry. After signing con-
sent documents, 38 (n 38) frequent replacement SCL wearers
completed a prospective randomized, cross-over SCL clinical trial
that lasted for 4 weeks. Subjects were randomized at baseline to
daily wear of either senofilcon A (Johnson & Johnson Vision Care,
Inc, Jacksonville, FL) or balafilcon A (Bausch & Lomb, Rochester,
NY) and then crossed over to the other lens at the 2-week visit
(Table 1). All subjects were given OPTI-FREE EXPRESS MPDS
(Alcon Laboratories, Ft. Worth, TX) with a screw-top lens case,
and OPTI-FREE EXPRESS Rewetting Drops (Alcon Laborato-
ries, Ft. Worth, TX) as needed.
At each visit (baseline, 1, and 2 weeks after each cross over for a
total of five visits), responses to the long form of the CLDEQ were
analyzed to identify items with the highest correlation to overall
opinion of the SCLs at that visit (Poor, Fair, Good, Very Good,
and Excellent). Groups of items that were most often highly cor-
related with overall opinion were tested in versions of the short
form of the CLDEQ instrument after checking for redundant
information (high inter-item correlation). Items with low correla-
tions were not included in the combinations of questions that were
tested. Items were removed in order of lower to higher correlation
until there was no further impact on the analysis of variance
(ANOVA) for the overall relationship to overall opinion of SCLs.
Known Groups Validity Phase
The purpose of the known groups validity phase was to val-
idate the short CLDEQ-8 consisting of eight questions—by
testing the sum scores for their ability to reflect overall opinion of
TABLE 1.
Study products
Feature
Item Reduction Phase n 38
Treatment arm A Treatment arm B
Lens material Senofilcon A Balafilcon A
Brand name ACUVUE OASYS Contact Lens with
HYDRACLEAR
BAUSCH & LOMB PureVision Visibility
Tinted Contact Lens
Power range 0.50 to 6.00 DS
Base curve 8.4 mm, 8.8 mm 8.3 mm, 8.6 mm
Diameter 14.0 mm
Lens care system OPTI-FREE EXPRESS MPDS
Screw top lens case
OPTI-FREE EXPRESS Rewetting Drops as needed
Wearing schedule Daily wear
1436 Dry Eye Questionnaire and Overall Opinion of Contact Lenses—Chalmers et al.
Optometry and Vision Science, Vol. 89, No. 10, October 2012
habitual SCLs at baseline and for the score’s responsiveness to
change in overall opinion after randomization to two silicone hy-
drogel SCL materials. To accomplish this, the short form of the
CLDEQ-8 was fielded to a much larger convenience sample in 24
North American clinical sites as part of a larger randomized pro-
spective clinical trial. Subjects (n 379) in an institutional review
board-approved, multicenter, randomized parallel group trial
completed the short form of the CLDEQ-8, and anchoring ques-
tion on overall opinion of SCLs, and other questionnaires at
baseline and 2 weeks after randomization to daily wear of either
senofilcon A or lotrafilcon B silicone hydrogel lenses (Table 1). In
this validation phase, subjects were allowed to continue to use their
habitual care system (if appropriate) with the following distribution:
OPTI-FREE RepleniSH 31%, ReNu MPDS 17%, OPTI-FREE
EXPRESS MPDS 11%, and Clear Care 11%. Thirty percent
(30%) of subjects were not using an appropriate care system (saline
only or unknown system) and were given COMPLETE Multipur-
pose lens care kits at the baseline visit.
Change in overall opinion was measured by comparing the over-
all opinion rating (“Which statement best describes your overall
opinion of your current contact lenses?” with response options of
Poor, Fair, Good, Very Good, and Excellent) of habitual lenses to
lenses to which the subject was randomized in the trial. For exam-
ple, change in a worse direction would exist if the subject reported
Very Good with habitual lenses and Good with new lenses.
Change in assessment by two steps was considered “Much Worse”
if it was in the worsening direction and “Much Better” if there were
two levels of improvement in the overall opinion.
Only subjects with complete data sets (n 309) were included
in this analysis. Summed CLDEQ-8 scores (possible 0–37) were
tested for correlation with overall opinion of habitual lenses
(Spearman’s rank correlation coefficient) and then for responsive-
ness to change in overall opinion after randomization by ANOVA.
Statistical significance was assumed if p 0.05.
RESULTS
Subject Demographics
Table 2 shows the demographics of the subject sample in each
phase of the research and the distribution of habitual SCLs and
care systems for subjects in each phase. Note that habitual lens care
system was not queried in the item reduction phase of the research.
Item Reduction Phase
A number of CLDEQ questions were significantly correlated
with overall opinion of contact lenses, with more questions show-
ing significant correlations at visits after randomization than at
baseline. Correlations between individual CLDEQ symptom
questions at all visits are listed in Table 3.
Ranking of these correlations was used to model the best mix of
questions for the short form of the CLDEQ. A strategy that chose
TABLE 2.
Subject demographics
Factor
Item Reduction
Phase n 38
Known Groups
Validity Phase
n379
Gender
Female: N (%) 29 (76%) 261 (69%)
Male: N (%) 9 (24%) 118 (31%)
Age (yr)
Mean (SD) 24.4 (3.4) 29.5 (6.9)
Range 19–34 18–45
Habitual CL power
Mean (SD) 3.56 (1.57) 3.17 (1.40)
Keratometry reading
Horizontal/vertical in DK 43.80/44.50 43.81/44.52
Habitual contact lens type
Silicone hydrogel 29 (76.3%) 246 (64.9%)
Hydrogel (reusable) 9 (23.7%) 99 (26.1%)
Hydrogel (daily disposable) 34 (9.0%)
Contact lens solution type
MPS 305 (80.4%)
Hydrogen peroxide Not queried 44 (11.6%)
None 29 (7.7%)
Unknown 1 (0.3%)
TABLE 1.
(Continued)
Feature
Known Groups Validity Phase n 379
Treatment arm A Treatment arm B
Lens material Senofilcon A Lotrafilcon A
Brand name ACUVUE OASYS Contact Lens with
HYDRACLEAR
AIR OPTIX Aqua
Power range 1.00 to 6.00 DS
Base curve 8.4 mm 8.6 mm
Diameter 14.0 mm 14.2 mm
Lens care system Continue Habitual System
(31% OPTI-FREE RepleniSH, 17% ReNu MPDS, 11% OPTI-FREE EXPRESS, 11% ClearCare)
OR 30% AMO COMPLETE Multi-Purpose if no appropriate system at baseline
Wearing schedule Daily wear
Dry Eye Questionnaire and Overall Opinion of Contact Lenses—Chalmers et al. 1437
Optometry and Vision Science, Vol. 89, No. 10, October 2012
questions with the highest correlations and highest proportions of
significant correlations was put into a sequence that was then tested to
reduce redundancy. Some questions, such as burning/stinging,
showed very high statistically significant correlations with other items
that also had high correlation to overall opinion. Those questions were
eliminated from the final CLDEQ-8 short form, as they did not affect
the overall performance of the instrument’s ability to discriminate by
the wearer’s overall opinion of the SCLs they were wearing at that visit.
The CLDEQ-8 questions are shown in Fig. 1.
Known Groups Validity Phase
Fig. 2 shows the mean and distribution of CLDEQ-8 scores by
overall opinion of habitual lenses at baseline for the known groups
validity phase. The distribution of CLDEQ-8 scores by overall opin-
ion of lenses was as follows: Fair: 17.4 8.7, Good: 13.7 6.4, Very
Good: 9.1 4.7, and Excellent: 6.4 3.7, and the overall distribu-
tion was significant (ANOVA, F 291.1, p 0.001). There were no
subjects who reported Poor overall opinion at baseline.
TABLE 3.
Correlation of CLDEQ questions with overall opinion of lenses in Item Reduction Phase
Item Baseline
1 week
Arm A
2 weeks
Arm A
1 week
Arm B
2 weeks
Arm B
Discomfort—frequency 0.43
a
0.65
a
0.67
a
0.72
a
0.62
a
AM severity 0.00 0.35
b
0.68
a
0.44
a
0.37
b
PM severity 0.34
b
0.57
a
0.64
a
0.59
a
0.59
a
Bother 0.35
b
0.37
b
0.66
a
0.57
a
0.56
a
Dryness—frequency 0.26 0.58
a
0.49
a
0.59
a
0.68
a
AM severity 0.002 0.45
a
0.71
a
0.36
b
0.27
PM severity 0.19 0.48
a
0.59
a
0.42
a
0.61
a
Bother 0.26 0.42
a
0.58
a
0.50
a
0.63
a
Blurry vision—frequency 0.17 0.43
a
0.42
a
0.27 0.26
AM Severity 0.03 0.42
a
0.39
b
0.22 0.15
PM severity 0.17 0.46
a
0.52
a
0.35
b
0.30
Bother 0.13 0.36
b
0.52
a
0.27 0.21
Burning, stinging—frequency 0.14 0.27 0.47
a
0.48
a
0.49
a
AM severity 0.14 0.28 0.47
a
0.52
a
0.41
b
PM severity 0.15 0.36
b
0.52
a
0.37
b
0.49
a
Bother 0.09 0.32 0.47
a
0.42
a
0.48
a
Grittiness—frequency 0.13 0.44
a
0.27 0.40
b
0.58
a
AM severity 0.07 0.36
b
0.28 0.26 0.41
a
PM severity 0.26 0.37
b
0.29 0.40
b
0.48
a
Bother 0.21 0.37
b
0.28 0.34
b
0.55
a
Tired eyes—frequency 0.03 0.18 0.25 0.34
b
0.47
a
AM severity 0.27 0.30 0.38
b
0.12 0.21
PM severity 0.04 0.22 0.06 0.34
b
0.43
a
Bother 0.002 0.21 0.08 0.42
a
0.41
b
Other questions
Red eyes—frequency 0.21 0.35
b
0.11 0.001 0.34
b
Watery eyes—frequency 0.01 0.33
b
0.24 0.007 0.47
a
Crusty eyelids—frequency 0.03 0.15 0.06 0.007 0.09
Coping questions
Close eyes for relief—frequency 0.25 0.29 0.49
a
0.50
a
0.64
a
Remove lenses for relief—frequency 0.35
b
0.38
b
0.59
a
0.52
a
0.65
a
Artificial tear use 0.04 0.50
a
0.41
b
0.35
b
0.41
b
Environmental triggers
Cigarette smoke 0.19 0.16 0.02 0.10 0.18
Air conditioning 0.20 0.10 0.17 0.55
a
0.49
a
Malls 0.30 0.04 0.04 0.26 0.11
Self-assessment of dry eye
Think dry eye? 0.17 0.17 0.23 0.10 0.10
Bolded question titles indicate items that were included in CLDEQ-8.
Bolded figures in those rows show significant items.
a
p0.001,
b
p0.05.
1438 Dry Eye Questionnaire and Overall Opinion of Contact Lenses—Chalmers et al.
Optometry and Vision Science, Vol. 89, No. 10, October 2012
FIGURE 1.
CLDEQ-8 questionnaire.
Dry Eye Questionnaire and Overall Opinion of Contact Lenses—Chalmers et al. 1439
Optometry and Vision Science, Vol. 89, No. 10, October 2012
The distribution of change in overall opinion by change in
CLDEQ-8 score is shown in Fig. 3. Note that a lower CLDEQ-8
score indicates fewer symptoms and less need for coping actions. In
general, the 73 subjects who reported a worse overall opinion status
had an 8.5 5.8 point increase in the CLDEQ-8, the 218 in the
unchanged group had a decrease of 2.3 5.0 points, and the 11
subjects with improved status had a change of 16.7 10.0 points in
CLDEQ-8 scores. The distribution was significantly related to change
in overall opinion of SCLs (ANOVA, F 16.5, p 0.001).
DISCUSSION
Although numerous questionnaires have been developed to as-
sess dry eye symptoms without contact lens use,
22–25
and others to
assess quality of life across refractive correction,
25–29
the CLDEQ
is one that was developed to assess dry eye symptoms among con-
tact lens wearers in particular. A population-specific SCL question-
naire is required because SCL wearers report a distinctly different
pattern of symptoms compared with people who do not wear
SCLs.
16
For example, in an age-matched sample of SCL wearers
and non-wearers, more than twice as many SCL wearers reported
intense dryness, especially late in the day, but these symptoms were
nearly eliminated when they removed lenses.
4
In that study, symp-
tom patterns also differed between SCL wearers and age-matched
non-wearers; in SCL wearers, dryness intensity was not correlated
with gender although it was inversely correlated with age among
contact lens wearers, differing significantly from the pattern
among non-lens wearers in which females and older patients report
more dryness.
Because SCL-related dryness is not a disease, we developed a
responsive tool to measure its recovery. The CLDEQ-8 was able to
reflect improvement and worsening of overall opinion after ran-
domization to new lenses. The SCL wearer’s opinion can change
after refitting with new lens designs, materials, lens care products,
and with new replacement schedules; thus, the score to reflect that
opinion should be developed by methods that sample patients’
symptoms during the refitting process.
The CLDEQ-8 is a short form of the CLDEQ questionnaire
that was designed to describe symptoms among SCL wearers. The
short form was developed by selecting items that related to the
wearer’s global opinion of the SCLs they were wearing across all
study visits. The number of items was then reduced to avoid re-
dundancy owing to very high inter-item correlation. The eight
remaining items were also capable of reflecting change in this opin-
ion after randomization to new lens brands in the second phase of
the study. Scores from an earlier short CLDEQ version relied on
the response to the question “Do you think you have dry eye?,”
which was useful as a stratifying question in dry eye patients with-
out SCL wear.
30
Reliance on the Gestalt “Do you think you have
dry eye?” question may not be a good approach with SCL wearers,
as many of them have few symptoms while not wearing lenses.
4
Therefore, SCL wearers with dry eye complaints may not globally
consider themselves to have dry eye separately from SCL wear. The
overall opinion question used in this study focuses on the SCLs and
not on the patient’s underlying condition of eye dryness. In addi-
tion, the earlier short CLDEQ formula was less intuitive and pos-
sibly more cumbersome for clinician users to implement.
The CLDEQ-8 score shows an excellent dose–response rela-
tionship to the subjects’ overall opinion of SCLs, making it a
potentially useful tool for capturing the patient-reported opinion
of new SCL treatments. There was a slight dampening of linearity
FIGURE 2.
CLDEQ-8 score by overall opinion of habitual lenses; known groups validity phase.
FIGURE 3.
CLDEQ-8 score against change in overall opinion; known groups validity
phase. (Much Worse, n 73; No Change, n 218; Much Better, n 11).
1440 Dry Eye Questionnaire and Overall Opinion of Contact Lenses—Chalmers et al.
Optometry and Vision Science, Vol. 89, No. 10, October 2012
in the scale when we related it to change in opinion after refitting
with new lenses. Subjects showed larger change in score when they
reported an improvement in overall opinion (mean decrease of
16.7 points) compared with when they had a lower overall opinion
of the new lenses (mean increase of 8.5 points). Other researchers
have shown that the structure of the DEQ questions showed lin-
earity by Rasch analysis.
31
In this sample, we were unable to assess
the lowest end of the scale, as none of the subjects presenting for
the clinical trial had an estimation of “Poor” for their habitual
SCLs. Contact lens-related dryness differs from dry eye disease
(fortunately for the lens wearers) in that the patient is able to cease
wear if the lenses are so uncomfortable that they would warrant a
poor rating. Inability to test that end of the scale is a limitation in
the development of the instrument. Repeatability of the instru-
ment should also be established in other patient populations in the
future.
For diagnostic use and categorization, a valid and useful instru-
ment must be able to distinguish between groups that are otherwise
identifying themselves as different, a feature referred to as having
construct validity. The items in the CLDEQ-8 were selected from
the ocular surface symptoms, environmental triggers, and coping
items in the longer CLDEQ questionnaire. Also, the selection was
based on patient opinion of SCLs after changes between marketed
lens brands, so the CLDEQ-8 is scaled to perform well to reflect
changes of a magnitude that are clinically achievable through
change in available products.
Ideally, we would like to understand the underlying biological
basis of SCL-related dryness symptoms and have means of measur-
ing those specific factors. However, with or without that basic
understanding, a gold standard, or highly repeatable clinical tests,
it remains important to be able to measure symptoms as assessed by
individual SCL wearers in the clinical or clinical trial setting. The
CLDEQ-8 allows a standardized quick means to measure this
symptom-based condition from the wearer’s point of view. Note
that two vision (frequency and late day intensity) and two coping
(removing lenses early and closing eyes for relief) questions are
included in the CLDEQ-8 but were not the most discriminating
questions in the short form of the DEQ-5.
21
With SCL wear, the
prelens tear film is significantly less stable with SCLs compared
with the precorneal tear film in patients without SCLs
32,33
; there-
fore, changeable blurry vision has been cited as a more prominent
symptom in the SCL population. Blurry vision that clears with a
blink is the third most common symptom among SCL wearers,
close behind discomfort and dryness. This complaint of transient
blurry vision most likely stems from the tear break up that occurs
between blinks in SCL wearers.
34
This recent study of blinking
patterns during different cognitive tasks with and without SCL
wear showed that the unstable prelens tear film, and symptoms
associated with it, drove an increase in blink frequency during SCL
wear compared with no wear.
The two coping questions included in the CLDEQ-8, the need
to close the eyes and early lens removal, capture the wearer’s strug-
gle with uncomfortable lenses. Subjects in this study with lowest
overall opinion of SCLs were more likely to frequently close their
eyes for a prolonged time or to finally capitulate and remove lenses
before the desired time. It is clear that these symptoms alter the
SCL-wearing experience and reflect a significant impact on the
wearers who experience them.
In this study, we validated the eight-item short form of the
CLDEQ as a means of testing the SCL wearer’s symptom-related
experience with their contact lenses. The sum of scores for the eight
items was significantly related to overall opinion of lenses and was
also able to reflect change in overall opinion in prospective treat-
ment trials. The CLDEQ-8 will be useful for identification of SCL
wearers who may benefit from lenses or lens care products designed
to reduce symptoms of dryness with SCL wear and to track their
progress in treatment trials.
ACKNOWLEDGMENTS
This study was funded by Johnson & Johnson Vision Care, Inc., and designed
by RLC, CGB, and KM. We thank Graeme Young, PhD, MPhil, FCOptom,
DipCL, FAAO, and Chris Hunt, MSc, and the staff at Visioncare Research for
their assistance in fielding the CLDEQ-8 in the Known Groups Validity
Phase.
Received March 5, 2012; accepted June 6, 2012.
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Robin L. Chalmers
Clinical Trial Consultant
2097 East Lake Road
Atlanta, Georgia 30307
e-mail: Chalmers2097@gmail.com
1442 Dry Eye Questionnaire and Overall Opinion of Contact Lenses—Chalmers et al.
Optometry and Vision Science, Vol. 89, No. 10, October 2012
... Participants also completed the eight-question Contact Lens Dry Eye Questionnaire (CLDEQ-8) survey, which specifically asks patients to answer the questions based upon their experiences over the past 2 weeks of lens wear. 22,23 Additionally, participants completed a final survey which included questions regarding the participants' experiences with daily disposable lenses and with the study lenses. The scales for convenience, ease of use, and preference for daily disposable contact lenses were 0 to 10, where a score of 0 was not convenient, easy, or preferred; 5 was marked as neutral; and 10 was labelled as very convenient, easy, or preferred. ...
Article
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Objective: The purpose of this study was to assess the wear experience of participants while wearing a toric daily disposable contact lens with water surface technology over long days of lens wear. Methods: Existing soft toric contact lens wearers were fit with the daily disposable study lenses. Participants assessed their initial comfort, vision, and satisfaction with the lenses by visual analog scale (VAS) survey. After a successful 1-week follow-up visit, participants were scheduled for 5 survey days, in which surveys were deployed to their smartphones for immediate assessments of comfort and quality of vision on a 1-10 scale at 10, 12, 14, and 16 hours of lens wear on 5 subsequent weeknights. The final study visit assessed visual acuity, and overall lens wear experience surveys were completed with VAS surveys. The overall median and interquartile (IQR) range of all surveys were calculated. Results: Thirty bilateral toric lens wearers completed the study. Median (IQR) initial impression VAS scores were 97(12) for quality of vision, 100(9) for comfort, and 96(10) for satisfaction. Median evening surveys resulted in comfort scores of 10(1) at 10 hours, 9(2) at 12 hours, 9(2) at 14 hours, and 8(2) at 16 hours of wear. Median evening surveys resulted in quality of vision scores of 10(1) at 10 hours, 10(2) at 12 hours, 9(2) at 14 hours, and 9(3) at 16 hours of wear. VAS scores for overall experience were 97(9) for comfort, 95(13) for vision, and 8(31) for dryness. End-of-day VAS scores were 93(21) for comfort, 90(15) for vision, and 21(38) for dryness. Mean (±standard deviation) OU LogMAR visual acuity with the study lenses was -0.19(0.06). Conclusion: Surveys of wear experience resulted in high scores for comfort and vision over the course of a long day of wear with the daily disposable study lenses in this population of patients with astigmatism.
... In the year 2009, an abbreviated version of this questionnaire was developed and validated with eight questions (CLDEQ-8) designed to evaluate the severity of dry-eye symptoms in soft-CL users in the past 2 weeks [14,15]. Each question was answered using a Likert scale of 0 to 4, 0 to 5, or 1 to 6, and the total score was evaluated based on a scale from 0 to 37. The cut-off score for dry-eye diagnosis was established at ≥12 points [15,16]. ...
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Background: Determine whether the presence of ocular symptoms in soft-contact-lens wearers changes depending on the refractive status. Methods: During the months of January to March 2022, the CLDEQ-8 questionnaire was administered to soft-contact-lens wearers. The statistical analysis was carried out using the SPSS 27.0 computer program (SPSS Inc., Chicago, IL, USA). Results: A total of 251 subjects participated in the study, with a higher percentage of myopes than hyperopes (82.1% versus 16.7%; p < 0.001). Out of all total participants, 21.5% suffered from dry-eye symptoms. It was noted that hyperopes presented a higher rate of dry-eye symptoms (p = 0.041). At the same time, the spherical equivalent was more positive in the participants with dry-eye symptoms (p = 0.014). Significant differences were found based on the symptoms present with contact lenses and the degree of myopia. The intensity of visual disturbances was higher in the participants with medium myopia (median [IQR]: 1/5 [2]) compared to those with low (median [IQR]: 0/5 [2]) and high myopia (median [IQR]: 0/5 [1]) (p = 0.009). Conclusions: Contact-lens wearers with hyperopia showed a higher rate of ocular dryness than those with myopia. In turn, wearing daily-replacement lenses could be one of the reasons for the lesser presence of ocular dryness compared to monthly-replacement lenses.
... 57 La Tabla 3 resume los cuestionarios de EOS más frecuentemente empleados en la práctica clínica. 57,[60][61][62][63][64][65][66][67] Aunque el Ocular Surface Disease Index (OSDI) es el cuestionario más utilizado para los ensayos clínicos sobre EOS y para medir la frecuencia de los síntomas, los desencadenantes ambientales y la calidad de vida relacionada con la visión, toma más tiempo responderlo y puede necesitarse ayuda para contestarlo. 62 La opinión de consenso del Panel Mexicano de Expertos en ojo seco es que el Cuestionario sobre la enfermedad del ojo seco (DEQ)-5 es una alternativa excelente para las clínicas oftalmológicas que manejan un alto volumen de pacientes, ya que lleva menos tiempo contestarlo, posee una excelente capacidad discriminatoria y está validado al español para su uso en la población mexicana. ...
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La enfermedad del ojo seco (EOS) tiene una prevalencia mayor que muchas otras enfermedades sistémicas importantes, como las enfermedades cardiovasculares y la diabetes mellitus, y supone un importante menoscabo en la calidad de vida de los pacientes afectados. Es un motivo de consulta habitual en clínicas oftalmológicas en todo el mundo. Hoy en día, el diagnóstico y el enfoque terapéutico de los especialistas en córnea y superficie ocular deben reservarse para casos de ojo seco graves y crónicos asociados con enfermedades sistémicas autoinmunes o con patologías complicadas de la córnea y la superficie ocular. En dichos casos, el diagnóstico y el enfoque terapéutico suelen ser complejos, elaborados, prolongados y costosos, dado el uso de cuestionarios extensos sobre ojo seco, equipos de diagnóstico electrónico no invasivos y pruebas clínicas de laboratorio y auxiliares de diagnóstico. Más aún, otros especialistas en el cuidado ocular atienden un considerable número de casos de EOS, por lo que su diagnóstico, clasificación y manejo deberían ser algo sencillo, práctico, asequible y efectivo. Considerando que muchos pacientes que van a clínicas no especializadas para el tratamiento del ojo seco se beneficiarían de una mejor atención oftalmológica, hemos decidido elaborar un sistema práctico de clasificación de la EOS en base a su gravedad, para ayudar a los profesionales de la salud visual a discriminar los casos que precisen derivación de los pacientes a clínicas de alta especialidad. Además, proponemos un enfoque sistemático y consideraciones generales de manejo para mejorar los resultados terapéuticos de los pacientes en base a la gravedad de la enfermedad.
... 57 Table 3 summarizes the most frequently used DED questionnaires in clinical practice. 57,[60][61][62][63][64][65][66][67] Although the Ocular Surface Disease Index (OSDI) is the most widely used questionnaire for DED clinical trials, measuring symptoms frequency, environmental triggers, and vision-related QoL, it takes longer to answer and may require assistance to do so. 62 The consensus view of the Mexican Dry Eye Disease Expert Panel is that the Dry Eye Questionnaire (DEQ)-5 is an excellent alternative for busy eye care practices because it takes a shorter time to answer, has an excellent discriminative ability, and is validated to the Spanish language for use among the Mexican population. ...
Article
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Dry eye disease (DED) has a higher prevalence than many important systemic disorders like cardiovascular disease and diabetes mellitus, representing a significant quality of life burden for the affected patients. It is a common reason for consultation in general eye clinics worldwide. Nowadays, the diagnostic and therapeutic approach at the high corneal and ocular surface specialty level should be reserved for cases of severe and chronic dry eye disease associated with systemic autoimmune diseases or complicated corneal and ocular surface pathologies. In such cases, the diagnostic and therapeutic approach is often complex, elaborate, time-consuming, and costly due to the use of extensive dry eye questionnaires, noninvasive electronic diagnostic equipment, and clinical laboratory and ancillary tests. However, other eye care specialists attend a fair amount of DED cases; therefore, its diagnosis, classification, and management should be simple, practical, achievable, and effective. Considering that many patients attending non-specialized dry eye clinics would benefit from better ophthalmological attention, we decided to elaborate a practical DED classification system based on disease severity to help clinicians discriminate cases needing referral to subspecialty clinics from those they could attend. Additionally, we propose a systematic management approach and general management considerations to improve patients' therapeutic outcomes according to disease severity.
... There is a direct relationship between the time of CL use and the development of ocular discomfort, increasing its severity at the end of the day [23][24][25] and affecting daily life activities. It is not surprising then that the use of CL is one of the risk factors to developing dry eye disease (DED) [26,27], and that specific questionnaires for CL users have been developed, such as the contact lens dry eye questionnaire (CLDEQ) [28], the eight-item contact lens dry eye questionnaire (CLDEQ-8) [29], the contact lens impact on quality of life [30] and the recently designed contact lens discomfort index (CLDI) [31]. ...
Article
Full-text available
Dry eye disease (DED) is difficult to detect in young contact lens (CL) wearers, who usually have no signs, mild symptoms and an ocular surface disease index (OSDI) below the DED diagnosis values (OSDI ≥ 13). We investigate if some of the 12 OSDI questions (OSDI A—ocular symptoms; OSDI B—vision-related functionality; OSDI C—environmental triggers) contribute the most to classify young CL as symptomatic. TBUT and tear volume are also measured. Age, gender and refraction error-matched eye glasses (EG) wearers participated as the control. CL and EG data were compared with t-test and z-test. Confusion matrices and logistic correlation analyses were performed to define the contribution of each OSDI question to classify symptomatic subjects. OSDI classified symptomatic CL better than the tear volume or TBUT values. In CL, only OSDI B and C values were significantly higher in symptomatic vs. asymptomatic subjects (p < 0.001), while values of all twelve OSDI questions were significantly higher in symptomatic vs. asymptomatic EG (p < 0.05–0.001). All OSDI questions contribute equally to identify symptomatic EG, while only OSDI B questions on daily life visual functions are significant to classify symptomatic CL wearers at risk to develop DED or at a subclinical stage. CL wearers scoring ≥ 2 on the OSDI B questions should be considered for preventive treatments, even if their clinical sings are scarce or absent.
Article
Purpose To present the process that led to the creation of the French Canadian translated version of the Contact Lens Dry Eye Questionnaire-8 (which allows for an assessment of symptoms while wearing soft contact lenses) as well as the validation data of the f-CLDEQ-8. Methods The CLDEQ-8 went through the process of reverse translation, which was then reviewed and improved by an experts’ committee to create a first version of the French questionnaire. Cognitive interviews were conducted to pretest the tool and ensure content validity. After a review of the pretest, the f-CLDEQ-8 was created. A web-based version of this questionnaire was sent to contact lens wearers (CLW) recruited out of a clinical setting for completion at two different endpoints interspaced by 7 days. Internal consistency and test-reliability were calculated using Cronbach’s alpha and Intra-class Correlation coefficient (ICC), respectively. Convergent validity between the f-CLDEQ-8 score and overall opinion of the contact lenses was evaluated with a correlation. Results 9 CLW with different socio-economic statuses and education levels went through a cognitive interview with the back-translated version of the f-CLDEQ-8 to improve the questionnaire wording and enhance its comprehension. 63 CLW (34.2 ± 10.1 years old and 2/3 of them women) completed the f-CLDEQ-8 twice. An average Cronbach alpha of 0.928 was found and an ICC of 0.944 (CI at 95 % 0.905;0.966). A moderately strong correlation of −0.714 (CI at 95 % −0.817;-0.566) was found between the overall opinion of the contact lenses and the total score to the f-CLDEQ-8. Conclusion The French language version (f-CLDEQ-8) generated from the original CLDEQ −8 was shown to be easy to use, reliable and culturally adapted to French spoken in Canada.
Article
Purpose: Clinicians play a key role in prescribing contact lenses that best suited for fitting which materials had an impact on ocular surface parameters. The present study aimed to evaluate the impact on symptomatology, tear film dynamics and ocular surface integrity of a silicone-hydrogel (Somofilcon-A) and a hydrogel (Omafilcon-A) lens before and after wearing for one week in contact lens neophyte participants. Methods: A Somofilcon-A and Omafilcon-A were randomly fitted to one or other the eye on an initial group of 28 participants. Subjects were scheduled for three sessions: basal session previous fitting, second session after 4-wear hours, and final session after 7-wear days for up to 10 h. In each session, CLDEQ-8, tear meniscus height and hyperemia with and without lenses, as well as lipid layer thickness and corneal/conjunctival staining without lenses were assessed. Values were compared between lenses and sessions. Results: In intrasession comparison, there were no differences in any parameter between materials on any session with or without lenses (all p≥0.176), except on the conjunctival staining where values obtained during Somofilcon-A wear (all p ≤ 0.006). In intersession analysis, CLDEQ-8 score, tear meniscus height and lipid layer thickness showed a statistical difference during both materials wear (all p ≤ 0.009), while conjunctival hyperemia does not (p = 0.237); corneal staining showed differences during Omafilcon-A wear (p = 0.037), contrary to conjunctival staining which showed differences only during Somofilcon-A wear (p < 0.001). Conclusion: Contact lenses wear had an impact on ocular parameters that have some specific influences of the material on which lenses were manufactured.
Article
Purpose: To compare objective and subjective digital near visual performance and comfort in low to moderate astigmatic participants fitted with toric versus spherical equivalent silicone hydrogel daily disposable contact lenses. Methods: This was a double-masked, randomised, crossover study. Participants aged 18 to 39 years with astigmatism of -0.75 to -1.50 D were recruited and fitted with toric and spherical contact lenses, in random order. Outcomes were measured at baseline and after 1 week of wear with each contact lens type after the follow-up visits. High- and low-contrast near logMAR visual acuity, automated visual acuity, zoom (%), contrast (%), reading distance (cm), critical print size (logMAR) and reading speed were assessed. Participants also completed the validated Near Activity Visual Questionnaire (NAVQ) and Contact Lens Dry Eye Questionnaire 8 (CLDEQ-8) for each correction type. Results: Twenty-three participants completed the study (74% female, average age 24.4 ± 4.2 years). When participants wore toric contact lenses, near high- and low-contrast visual acuity and automated visual acuity improved by 3-4 letters (all p < 0.03) and participants were able to read faster on an iPad (p = 0.02). Participants were also able to read with 8% less contrast on the iPad with toric lenses (p = 0.01). Participants reported better subjective vision on the overall NAVQ (p = 0.001) and better comfort on the CLDEQ-8 (p = 0.02) with toric lenses. Fewer participants reported difficulty with maintaining focus at near, reading small print, reading labels/instructions, reading the computer display/keyboard and reading post/mail with toric correction. Conclusions: Toric contact lenses improve comfort, subjective and objective visual performance with digital devices and other near tasks compared with the spherical equivalent correction in participants with low to moderate astigmatism.
Article
Purpose: To assess the safety and tolerability of a new contact lens sensor (CLS) system for continuous 3- and 24-hr intraocular pressure (IOP) monitoring in human eyes. Methods: Twenty-five subjects were recruited for 3-hr IOP measurement by CLS. Corneal fluorescein staining (CFS) scores were evaluated before and after measurement. Then, 30 participants (10 normal subjects and 20 glaucoma patients) were recruited for 24-hr IOP monitoring. Ocular surface disease index (OSDI) was assessed before and one day after measurement. Contact lens dry eye questionnaire-8 was assessed immediately after measurement. Visual analog scale of discomfort was measured before, immediately after, and one day after measurement. Best-corrected visual acuity (BCVA), tear break-up time (TBUT), and CFS were assessed before, immediately after, and 1 day after measurement. Results: All participants completed 3- or 24-hr IOP measurement by CLS. Corneal fluorescein staining increased from 0.6±0.7 to 2.4±1.5 after 3-hr IOP measurement (P<0.001). For participants undergoing 24-hr IOP monitoring, OSDI increased from 9.1±9.7 to 18.0±12.4 (P=0.001). CLDEQ-8 score was 11.6±5.8. Visual analog scale increased from 11.1±14.2 to 35.2±21.8 after measurement (P<0.001) and decreased to 26.7±18.4 one day later (P<0.001 compared with baseline). BCVA decreased from 1.0±0.01 to 0.8±0.1 (P<0.001) and returned to 0.9±0.1 after one day (P<0.001 compared with baseline). TBUT decreased from 5.1±3.9 to 2.6±1.5 s (P=0.001) and returned to 4.8±2.5 s (P=0.465 compared with baseline). Corneal fluorescein staining increased from 0.7±0.9 to 4.3±0.8 (P<0.001) and dropped to 0.8±0.7 (P=0.599 compared with baseline). No significant difference was found for all variations of indicators between normal subjects and glaucoma patients (P>0.1 for all comparisons). Conclusions: The CLS shows a great potential for a safe and tolerable 24-hr IOP monitoring in normal subjects and glaucoma patients. Clinical attention to the worsening signs and symptoms after measurement is required.
Article
Purpose To determine the frequency and severity of ocular symptoms and signs in new orthokeratology (ortho-k) subjects using a povidone iodine (PI) disinfecting system compared to those present before lens wear, and whether these were associated with cleaning regimes. Methods This study recruited 80 subjects from two myopia control studies, who used a PI disinfecting solution for routine use. Ocular symptoms and signs at baseline, one- and six-month after lens wear were reported via questionnaires and ocular examination, respectively. To determine if rates of occurrence were attributable to differences in cleaning regime, subjects were randomly assigned into four groups with respect to routine care procedures, which involved various combinations of rubbing and use of a daily and/or enzymatic cleaner. Results Sixty-eight subjects completed all aspects of the study. As there were no significant differences in incidence of signs and symptoms between the four groups before and after lens wear (Friedman tests, p > 0.07), data were combined for further analysis. Prior to lens wear, itchiness (69 %) and dryness (53 %) were the most commonly reported symptoms. The frequency and severity of all symptoms remained similar after lens wear (p > 0.10). Presence of follicles in the lower tarsal conjunctiva (22 %) and conjunctival injection (15 %) was frequently observed, but reduced significantly after lens wear (p < 0.01). Mild corneal staining, noted in 13 % of subjects at baseline, did not change significantly over time (p = 0.17). Ocular signs were not necessarily reflected in symptoms and vice versa. Conclusion Use of a PI-based solution did not increase the frequency or severity of ocular signs and symptoms observed before lens wear. Absence of a difference in occurrence of ocular discomfort with respect to cleaning regimes indicated that the use of the PI-based solution may adequately clean the lenses over a 6-month period.
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To develop and validate a comprehensive patient-reported outcomes instrument focusing on the impact of dry eye on everyday life (IDEEL). Development and validation of the IDEEL occurred in four phases: 1) focus groups with 45 dry eye patients to develop a draft instrument, 2) item generation, 3) pilot study to assess content validity in 16 patients and 4) psychometric validation in 210 subjects: 130 with non-Sjögren's keratoconjunctivitis sicca, 32 with Sjögren's syndrome and 48 controls, and subsequent item reduction. Focus groups identified symptoms and the associated bother, the impact of dry eye on daily life and the patients' satisfaction with their treatment as the central concepts in patients' experience of dry eye. Qualitative analysis indicated that saturation was achieved for these concepts and yielded an initial 112-item draft instrument. Patients understood the questionnaire and found the items to be relevant indicating content validity. Patient input, item descriptive statistics and factor analysis identified 55 items that could be deleted. The final 57-item IDEEL assesses dry eye impact constituting 3 modules: dry eye symptom-bother, dry eye impact on daily life comprising impact on daily activities, emotional impact, impact on work, and dry eye treatment satisfaction comprising satisfaction with treatment effectiveness and treatment-related bother/inconvenience. The psychometric analysis results indicated that the IDEEL met the criteria for item discriminant validity, internal consistency reliability, test-retest reliability and floor/ceiling effects. As expected, the correlations between IDEEL and the Dry Eye Questionnaire (a habitual symptom questionnaire) were higher than between IDEEL and Short-Form-36 and EuroQoL-5D, indicating concurrent validity. The IDEEL is a reliable, valid and comprehensive questionnaire relevant to issues that are specific to dry eye patients, and meets current FDA patient-reported outcomes guidelines. The use of this questionnaire will provide assessment of the impact of dry eye on patient dry eye-related quality of life, impact of treatment on patient outcomes in clinical trials, and may aid in treatment effectiveness evaluation.
Article
Purpose. The impact of dry eye on everyday living (IDEEL) is a valid, reliable questionnaire with 3 modules; symptom bother (SB), quality of life, and treatment satisfaction. This study tests the utility of the 20-item IDEEL-SB to discrimate self-assessed severity in dry eye subjects and to determine the clinically important difference (CID) in IDEEL-SB score that relates to a self-report of global change in dry eye condition after treatment. Methods. After randomization to 1 of 3 marketed tear replacements, dry eye subjects completed the IDEEL-SB at baseline, I and 4 wk and global change questionnaire on status of general health and dry eye at 1 and 4 wk (5-point Likert scale; "much better" to "much worse"). The IDEEL-SB score was the unweighted mean score X 25. CID was initially estimated by receiver-operator curve analysis (ROC) and global change questionnaire. Various IDEEL-SB change criteria were tested to maximize % agreement, K score, and effect size. Results. The 74 subjects were 54.0 +/- 17.2 years old and 52 (70.3%) were female. At baseline, 56.3% rarely/never used replacement tears. Subjects rated their dry eye severity as mild (41%), moderate (50%), or severe (9%). IDEEL-SB discriminated dry eye severity well; average baseline scores were mild: 40.0 (SD = 7.5), moderate: 50.6 (SD = 11.0) and severe 64.3 (SD = 8.0) (p = 0.001). After 4 wk of drops usage, IDEEL-SB dropped among "improved" subjects by -13.3 (SD = 10.9), "same" shifted by -4.7 (SD = 9.4), "worsened" changed by 1.4 (SD = 11.1). ROC results show that a 12-point change in IDEEL-SB is a clinically significant change in symptoms. Conclusions. 12-Point shift in the IDEEL-SB module is a CID based on ROC and the distribution across self-assessed severity groups compared with their global assessment of change in condition with treatment.
Article
Objective To evaluate the validity and reliability of the Ocular Surface Disease Index (OSDI) questionnaire.Methods Participants (109 patients with dry eye and 30 normal controls) completed the OSDI, the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25), the McMonnies Dry Eye Questionnaire, the Short Form-12 (SF-12) Health Status Questionnaire, and an ophthalmic examination including Schirmer tests, tear breakup time, and fluorescein and lissamine green staining.Results Factor analysis identified 3 subscales of the OSDI: vision-related function, ocular symptoms, and environmental triggers. Reliability (measured by Cronbach α) ranged from good to excellent for the overall instrument and each subscale, and test-retest reliability was good to excellent. The OSDI was valid, effectively discriminating between normal, mild to moderate, and severe dry eye disease as defined by both physician's assessment and a composite disease severity score. The OSDI also correlated significantly with the McMonnies questionnaire, the National Eye Institute Visual Functioning Questionnaire, the physical component summary score of the Short Form-12, patient perception of symptoms, and artificial tear usage.Conclusions The OSDI is a valid and reliable instrument for measuring the severity of dry eye disease, and it possesses the necessary psychometric properties to be used as an end point in clinical trials.
Article
Objective/backgroundTo describe the Refractive Status and Vision Profile (RSVP), a questionnaire that measures self-reported vision-related health status (symptoms, functioning, expectations, concern) in persons with refractive error.
Article
The aim of the DEWs Definition and Classification Subcommittee was to provide a contemporary definition of dry eye disease, supported within a comprehensive classification framework. A new definition of dry eye was developed to reflect current understanding of the disease, and the committee recommended a three-part classification system. The first part is etiopathogenic and illustrates the multiple causes of dry eye. The second is mechanistic and shows how each cause of dry eye may act through a common pathway. It is stressed that any form of dry eye can interact with and exacerbate other forms of dry eye, as part of a vicious circle. Finally, a scheme is presented, based on the severity of the dry eye disease, which is expected to provide a rational basis for therapy. these guidelines are not intended to override the clinical assessment and judgment of an expert clinician in individual cases, but they should prove helpful in the conduct of clinical practice and research.
Article
To collect questionnaire data from patients in a large clinical population that would allow for an estimate of the prevalence of self-reported symptoms of dry eyes. A 13-point questionnaire (The Canada Dry Eye Epidemiology Study, CANDEES) was mailed to all optometric practices in Canada in October 1994, with the request that it be completed by 30 successive nonselected patients. Four hundred fifty sets of questionnaires (total, 13,517) were analyzed (a 15.7% return rate) from patients aged from < 10 years to > 80 years; 55% were in the 21- to 50-year age group; 60.7% were female; and 24.3% were contact lens wearers. A total of 28.7% reported dry eye symptoms, of whom 24.2% reported concurrent dry mouth, 24.5% had worse symptoms in the morning, 30.3% reported concurrent lid problems, and 35.7% reported a history of allergies. Of the 3716 patients reporting symptoms, 62 (1.6%) were in the "severe" category and 290 (7.8%) were in the "constant but moderate" category. Contact lens wear, concurrent allergies, dry mouth, lid problems, or use of medications increased the chance of a patient reporting dry eye symptoms. The prevalence of patients reporting any level of symptoms of dry eyes was approximately 1 in 4; severe symptoms were reported by 1 in 225 patients.
Article
Objective To collect questionnaire data from patients in a large clinical population that would allow for an estimate of the prevalence of self-reported symptoms of dry eyes, Methods, A 13-point questionnaire (The Canada Dry Eye Epidemiology Study, CANDEES) was mailed to all optometric practices in Canada in October 1994, with the request that it be completed by 30 successive nonselected patients, Results, Four hundred fifty sets of questionnaires (total, 13,517) were analyzed (a 15.7% return rate) from patients aged from <10 years to >80 years; 55% were in the 21- to 50-year age group; 60.7% were female; and 24.3% were contact lens wearers, A total of 28.7% reported dry eye symptoms, of whom 24.2% reported concurrent dry mouth, 24.5% had worse symptoms in the morning, 30.3% reported concurrent lid problems, and 35.7% reported a history of allergies, Of the 3716 patients reporting symptoms, 62 (1.6%) were in the ''severe'' category and 290 (7.8%) were in the ''constant but moderate'' category, Contact lens wear, concurrent allergies, dry mouth, lid problems, or use of medications increased the chance of a patient reporting dry eye symptoms, Conclusions, The prevalence of patients reporting any level of symptoms of dry eyes was approximately 1 in 4; severe symptoms were reported by 1 in 225 patients.
Article
To prospectively investigate the effects of 2 week senofilcon A contact lens (CL) daily wear on the functional visual acuity (VA), ocular surface and tear film. Seventeen right eyes of 17 senofilcon A CL wearers without any ocular or systemic diseases were examined before and 2 weeks after lens wear. Visual acuity measurements, tear evaporation rate, ELISA for tear cytokines, strip meniscometry, tear lipid layer interferometry, tear film break-up time (BUT), in vivo confocal microscopy, corneal sensitivity, ocular surface vital staining, Schirmer I test and brush cytology for MUC5AC mRNA expression were performed before and after CL wear. The best corrected Landolt VA, functional VA parameters, the mean lipid layer interferometry grades, tear evaporation rates, Schirmer test values, vital staining scores and in vivo confocal microscopy parameters did not show any significant differences after 2 weeks of CL wear. The tear film BUT showed a significant decrease together with a significant down regulation of MUC5 AC mRNA expression after CL wear. A statistically significant elevation in the mean tear interleukin (IL)-6 concentration was also observed after 2 weeks of CL wear. Two week senofilcon A daily CL wear seems to be associated with tear instability, a decrease in MUC5AC expression, and elevation of IL-6 in tears without significant alterations in epithelial damage scores or in the morphology or density of in vivo keratoconjunctival cells and nerves. Alterations associated with long term wear and patients with dry eye disease need to be studied in future trials.