Download Report

Clinical Performance of Extreme Range
Contact Lenses for High Refractive Errors
Cheryl McKinnon, OD, PhD, FAAO, Paul Chamberlain, BSc (Hons), Wenjuan Feng, MS
CooperVision, Inc., Pleasanton, CA
Results
To compare the clinical performance of cast-molded,
Biofinity® XR (XR) (CooperVision®) silicone hydrogel
lens (SH) with subjects’ habitual contact lens
corrections. All subjects were fitted in the
CooperVision Biofinity® XR lenses.
Methods and Materials
•
•
•
•
This was a two-week, open label, daily wear,
dispensing study conducted at four (4) investigational
sites.
19 single-vision contact lens wearers with lens
powers >-12D or > +8 with 20/50 or better in at least
one eye were recruited.
Subjects were examined at the baseline visit and
again after two weeks. High (HC) and low contrast
(LC) logMAR visual acuity, lens fit and subjective
ratings (0-100) were measured with habitual lenses.
Ocular health was also assessed.
Following an over-refraction, an XR lens was fitted
and lens power confirmed. Subjects were then
dispensed lenses .
At the two-week visit, vision, lens fit, subjective
ratings and ocular health were repeated.
logMAR
*
*
HC VA
Lens Fit
Response
Performance
Acuvue 1-D Moist
Acuvue Oasys (SH)
Biofinity (SH)
TruEye (SH)
Precision UV
Hydrosoft options
Exception (H)
O2 Optix custom (SH)
2-wk follow-up
50%
40%
30%
20%
10%
0%
5%
slightly
decentered
extremely
decentered
Habitual
Material
Water Content (%)
Dk/t (-3.00)
Modulus (MPa)
BC/Diameter
Design
Power Range (D)
Comfilcon A
48
128
0.75
8.6/14.0
Asphere front surface
+15.00 to -20.00
Biof XR
*p=0.01
1.2
0.8
0.6
Figure 1: Distribution of subjects’ habitual lenses
0.4
*
0.2
Visual Acuity
• The HC and LC logMAR visual acuity were
significantly better with the XR lenses compared to
subject’s habitual visual acuity (p<0.04) (Figure 2).
Comfort
end of day
Comfort
overall
Dryness
Dryness
Overall
end of day satisfaction
Figure 5: Subjective comfort, dryness and satisfaction ratings
*p=0.01
Habitual
XR 2 week
*
0
Red
Bulbar
Red
Limbal
Corn
Corn Ext
StainType
Conj Stain
Conj
Indent
Figure 4: Mean anterior ocular responses
Palp red
Haziness
Vision
qual day
Vision
qual night
Ease of
handling
Ease of
removal
Figure 6: Subjective vision and handling ratings
1
Table 1: Contact lens parameters
*
Conclusions
Figure 3: Lens centration
48%
*
Ghosting
optimum
12%
Dispensing
60%
C-Vue Adv hydrogel (SH)
5%
Habitual
*p≤0.03
XR 2 week
*
Comfort
100
90
80
70
60
50
40
30
20
10
0
70%
5%
5%
Physiological
• Anterior ocular responses were graded low (mean
grade 1.0) (Figure 4).
Proclear
5%
and
Habitual
100
90
80
70
60
50
40
30
20
10
0
• The fitting characteristics of the XR lens, including
centration, movement and fit acceptance were as
good as or better than habitual lenses (Figure 3).
• A high proportion of subjects were successfully
fitted with one trial lens pair (79%) using best sphere
80%
over correction and trial fitting set.
5%
LC VA
• There was no relationship between VA or vision
quality and the change in over-refraction (R²=14-16%).
Trial fitting success
5%
*p=0.04
Figure 2: High and low contrast VA
• Hydrogels accounted for 68% and SH for 32%
of subjects’ habitual lenses.
• Proclear (48%) was the most common lens
followed by Acuvue 1-D Moist (12%) (Figure 1).
• 5 out of 19 subjects (26%) were undercorrected at screening (mean 0.70D) due to
limited power ranges in their non-custom habitual
lenses.
5%
Biofinity XR
(0-4)
•
0.36
0.32
0.28
0.24
0.2
0.16
0.12
0.08
0.04
0
10/9
43 ± 17
21-73
13
-13.6D ± 1.42D
(-12.50 to -17.00D)
6
+9.25 ± 0.52D
(+8.50 to +10.00D)
(0-100)
Purpose
Habitual
Table 2: Summary of Biometric Data
Gender: female/male
Age (Mean ± SD)
Age range
No of Myopes
Mean ± SD
(Range)
No. of Hyperopes
Mean ± SD
(Range)
Subjective Ratings
• Comfort, overall satisfaction and handling were rated as
excellent and similar to Habitual lenses.
• Significantly less dryness symptoms reported with XR
compared with Habitual lens.
• The XR lenses showed significantly higher ratings at end
of day for comfort and vision quality (Figures 5 & 6).
• XR preferred over habitual for overall performance,
although not significant (63% vs 21%, p=0.10).
(0-100)
The expectations for successful contact lens wear in
patients with high refractive errors should be the
same as those for ‘normal’ refractive errors, i.e.
excellent comfort, vision and ocular health. However,
the challenges to achieve these are greater because
of the geometries inherent in lens designs for these
prescriptions. Complaints of unstable lens fit, undercorrected VA, poor comfort and hypoxia concerns
are commonplace in this refractive error range.
These patients also face limited lens choices,
particularly in silicone hydrogel materials.
Results (cont’d)
(0-100)
Introduction
Papillae
•This study demonstrated an improved performance on a
number of objective and subjective assessments and
successful transition when re-fitted with the Biofinity XR
lenses.
•The expanded parameter range of spherical lenses (+8.50
to +15.00D and -12.50 to -20.00D) offers practitioners the
opportunity to meet the needs and challenges of patients
with high refractive errors.
•XR lenses provide the benefits of an advanced design in a
high oxygen permeable cast molded SH material.
Acknowledgements
Study conducted at CRC-UCB (Berkeley), CCLR (Waterloo), CORL (IU) and
TERTC (Houston). Supported by CooperVision, Inc.