Great
advances have occurred in contact lenses over the last several
years. High-oxygen-transmissibility silicone hydrogel lenses such as
Night & Day (CIBA Vision) have the comfort, movement and wettability
of conventional hydrogel contact lenses with the additional benefit
of nearly eliminating corneal hypoxia and its adverse effects on
corneal tissue.
Today
practitioners are increasingly prescribing and dispensing silicone
hydrogel lenses and even switching existing contact lens patients
into silicone hydrogel lenses. One advantage of the increased oxygen
transmissibility of these materials is a decrease in the probability
of developing corneal neovascularization or pannus. This increased
oxygen supply may actually contribute to regression of already
existing neovascularization.
In
addition to their higher oxygen permeability, some silicone
hydrogels have a higher material modulus. It's been postulated that
a stiffer material may provide improved vision because of decreased
lens flexure. How, then, would the quality of vision with a silicone
hydrogel contact lens compare with the quality of vision in a
conventional hydrogel lens?
Measuring Visual Acuity
The basis
of evaluating visual acuity (VA) with traditional letter charts is
that the smallest high-contrast letters that a patient can correctly
read provides an accurate measurement of visual function. We should
use some measure of low-contrast vision when a discrepancy seems to
exist between relatively good high-contrast visual performance and
the extent of reduced subjective visual function. Researchers have
used high- and low-contrast VA measurements for evaluating modes of
correction for refractive error including contact lenses, but with
varying results.
We
performed a clinical evaluation comparing vision with Night & Day
planned replacement lenses and CIBA's Focus Monthly lenses using
high- and low-contrast Bailey-Lovie charts under conditions of
normal room illumination.
Lens Designs
Both
Night & Day and Focus Monthly lenses are intended for replacement
every 30 days. However, their similarities end here as Night & Day
is an aspheric silicone hydrogel lens whereas Focus Monthly is a
spherical conventional hydrogel lens. Night & Day is made of
lotrafilcon A (38 percent water content) and is FDA-approved for 30
nights of extended wear. Focus Monthly is made of vifilcon A (55
percent water content) and is approved for daily wear and up to six
nights of extended wear. Night & Day has a 13.8mm diameter and comes
in 8.4mm and 8.6mm base curves. Its listed optical zone is 8.0mm and
its center thickness is 0.08mm (average). The Focus Monthly has a
diameter of 14.0mm and comes in 8.6mm and 8.9mm base curves. Its
optical zone is 8.0mm and its center thickness is 0.08mm (at
-3.00D).
Twenty-five subjects who were current soft spherical contact lens
wearers (19 women and six men, ages 23 to 50 years) from the
faculty, staff and student body of SUNY College of Optometry
completed the study. There were no restrictions regarding sex, race,
gender, current contact lens type or current care system. We
recruited only subjects who had 0.75D or less of refractive
astigmatism and were correctable to 20/25 or better with spherical
contact lenses. We obtained informed consent from all study patients
and our IRB approved the study.
The study
involved four visits. To determine that all eligibility criteria
were met, on the first visit each candidate underwent a sphero-cylindrical
refraction using maximum plus to best acuity, Snellen VA
measurements, slit lamp evaluation and manual keratometry. We then
diagnostically fit each patient with both Night & Day and Focus
Monthly lenses in each eye, determining the appropriate base curve
in accordance with the manufacturer's guidelines for initial base
curve selection and criteria for optimal lens movement. We
determined appropriate lens power by over-refraction using the
criteria of maximum plus to best VA.
At the
second visit, we randomly assigned the patients to begin lens wear
with a Night & Day lens in one eye and a Focus Monthly lens in the
fellow eye. We provided detailed instructions on application,
removal, wearing schedule and cleaning regimen utilizing Aquify
Multi-Purpose Solution (in accordance with CIBA's guidelines) at
this visit. We instructed all patients to wear the lenses on a daily
wear basis for two weeks for a minimum of five days each week and
for a minimum of eight hours each day.
Two weeks
later at the third visit, we used the slit lamp to re-evaluate each
patient's ocular health and lens fit. We determined high- and
low-contrast VA separately for right and left eyes using printed
Bailey-Lovie charts under controlled room illumination (70cd/m2
to 110cd/m2). We recorded visual acuity
as the total number of letters correctly identified until the
patient was unable to correctly identify three consecutive letters.
Patients then completed a subjective evaluation of vision using a
0mm to 100mm scale (where 0 represents the worst possible vision and
100 the clearest) for each eye separately. The scale contained five
descriptive markers at the 0mm, 25mm, 50mm, 75mm and 100mm marks to
assist patients in marking their vision as accurately as possible
(appendix A, available in the online version of this article at
www.clspectrum.com ).
At this
visit we provided an alternate pair of contact lenses such that the
eye previously wearing a Night & Day lens was switched into a Focus
Monthly lens and vice versa. Once again we confirmed fit and lens
power with the new lenses. Two weeks later at the fourth and final
visit we re-evaluated the fit of the lenses and ocular health in
each eye. We measured high- and low-contrast VA using the criteria
described above. The subjects again provided a subjective evaluation
of vision for each eye separately.
Results
Two
subjects who initially screened for inclusion in the study chose to
drop out because of poor lens comfort. The remaining 25 subjects
completed all four visits. Each of them demonstrated a good soft
lens fit with proper limbal to limbal centration with both the Night
& Day and the Focus Monthly lenses.
Tables 1 and 2 show the average number of correctly identified
high- and low-contrast letters after two weeks of lens wear, by
subject, for each lens type. Table 3
shows approximated Snellen equivalent acuity based on the total
number of correctly identified letters.
For the
Night & Day lenses, the average high- and low-contrast Snellen
equivalent acuity was 20/20+2 and 20/25-2
respectively. For the Focus Monthly lenses, the average high- and
low-contrast Snellen equivalent acuity was 20/20+1
and 20/25-2 respectively. A paired
t-test statistical comparison of the high-contrast Bailey-Lovie
visual acuity scores between the Night & Day and the Focus Monthly
lens types revealed no statistically significant difference (t =
1.037). Likewise, paired t-test comparison of the low-contrast
Bailey-Lovie visual acuity scores between the Night & Day and the
Focus Monthly lens types revealed no statistically significant
difference (t = 0.094). Study patients also provided subjective
vision scores following two weeks of wear for both the Night & Day
and the Focus Monthly lens types (Table
4). Similarly, we found no statistically significant difference
for subjective vision (t = 0.084).
Discussion
Many
different studies have evaluated visual acuity across various modes
of refractive error correction, but results of these studies have
been inconsistent. Some of the unpredictability of these results may
stem from continual improvement in contact lens design, different
methods of visual acuity measurement and/or small sample sizes.
Interestingly, the combination of high- and low-contrast visual
acuity is reportedly sensitive enough in normal subjects to provide
the same information that you would gain by measuring contrast
sensitivity. Because a contact lens rests directly on the eye,
flexure, decentration and tear lens formation are all possible and
each of these may impact final visual acuity. However, previous
studies have demonstrated that flexure and tear-lens formation do
not change the amount of on-eye aberration.
In
addition to the differences in material characteristics, Night &
Day, unlike Focus Monthly, is aspheric in design. This may
contribute to a difference in either objective or subjective visual
response. However, Vaz and Gundel (2003) failed to show any
consistent difference in vision between aspheric vs. spherical
design hydrogel lenses tested under similar conditions of normal
room illumination. As most normal eyes show only small amounts of
axial monochromatic aberration for photopic pupils up to around 3mm,
the limits to retinal image quality would then be set by
diffraction, uncorrected or imperfectly corrected refractive error,
accommodative error and/or chromatic aberration.
Our
results did not yield a statistically significant difference in
either objective or subjective visual acuity between the two lens
types in this study despite differences in lens material
flexibility. Some of the possible reasons for this may include small
study size, photopic pupil size and room illumination (as related to
pupil size).
Conclusion
Although
it's clear that silicone hydrogel lenses provide a superior
environment for the human cornea, our study failed to reveal a
difference in visual acuity and patient reported quality of vision
between the Night & Day silicone hydrogel lens and the Focus Monthly
hydrogel lens. Further studies limited to individuals who have large
pupils and/or testing under scotopic conditions may yield different
results.