Unilateral multifocal lens implantation

in patients with
a contralateral monofocal or phakic eye
is a viable presbyopic correction option

Robert J. Cionni, MD
Cincinnati Eye Institute, Cincinnati, OH

This study was supported by a research grant from Alcon Laboratories, Inc.
The author is a consultant for Alcon but has no direct financial interest in any product mentioned.
 Purpose
To report visual outcome data and patient-reported
measures on 52 patients unilaterally implanted with an
aspheric apodized diffractive lens
Many presbyopic patients require only one lens implantation
for cataract correction1
No documented studies show whether unilateral patients
might avoid some halo or glare experienced by some bilateral patients
will benefit from a ReSTOR multifocal intraocular lens (IOL),
though results from other multifocal IOLs are supportive2-3

1. Williams A, et al. Arch Ophthalmol 2006;124:1308-1314. 2. Shoji N, Shimizu K. J Cataract Refract Surg 2002;28:1012-1017.
3. Haring G, et al. J Cataract Refract Surg 1999;25:1151-1156. 4. Steinert RF, et al. Ophthalmology 1999;106:1243-1255.
Methods:
Patient Enrollment
During a six-month window, enrolled 67 patients under age 71 without
ocular comorbidities and with 1 D astigmatism
any eligible patient with 1
previous ReSTOR IOL Implant each bilateral multifocal
was recruited: yield n = 15 1 ReSTOR group

recruited for unilateral

group until each group
reached at least 20
patients

Monofocal IOLs (any

Implant each multifocal/monofocal
model) were present in 1 ReSTOR group
one eye of 20 patients
multifocal/
mixed
32 patients had no supergroup
previous cataract surgery Implant each multifocal/phakic
and needed an IOL in 1 ReSTOR group
only one eye
Methods:
Surgical Technique
Clear corneal incision (2.8 mm) at a location based on
reducing any preexisting corneal astigmatism
Complete hydrodissection
Circular capsulorhexis (5.5 mm)
Lens removed via bimanual phacoemulsification
Posterior lens capsule polished
SN60D3 ReSTOR IOL (Alcon Laboratories, Inc.)
implanted via Monarch II injector system
No posterior lens capsule breakage or outward vitreous flow
Patients received standard postoperative medications and a
routine 1day postoperative exam
 Methods:
Testing and Analysis
All examinations were conducted six months (30 days) postoperatively
Visual acuity
Best corrected and uncorrected visual acuity at 31 cm, 50 cm, and 4 m
assessed using ETDRS charts
Contrast sensitivity tested using a CSV-1000 (VectorVision), under
photopic (81 cd/m2), mesopic (3 cd/m2), and mesopic + glare conditions
Stereopsis assessed with the Titmus Fly stereo ring test
Lifestyle vision
Patients completed a 28-question survey assessing the lifestyle impact of the
apodized diffractive lens, including questions about
visual difficulty of performing everyday tasks, such as reading a newspaper, driving,
playing board games, watching television, playing sports, cooking
visual disturbances (such as halos and glare)
night vision
patient satisfaction
spectacle freedom

ETDRS = Early Treatment of Diabetic Retinopathy Study

 Results:
Uncorrected Visual Acuity
No statistical differences between the two unilateral subgroups
Bilateral group significantly better than the unilateral supergroup
at 31 cm
0.2
Multifocal/
Phakic,
0.15 n = 32

Multifocal/
logMAR acuity

Monofocal,
0.1
n = 20

Multifocal/
0.05
* Mixed,
n = 52
0
Bilateral
Multifocal,
n = 15
-0.05
31 cm 50 cm 4m
Distance

*P < 0.05
 Results:
Contrast Sensitivity & Stereopsis
Few significant differences or trends in contrast sensitivity

Photopic Mesopic Mesopic with glare

2 2

log units
log units
2
log units

** 1.5 1.5
1.5 1 1
*
0.5 0.5
1
3 6 12 18 3 6 12 18 3 6 12 18
cycles per degree cycles per degree cycles per degree

Multifocal/Phakic, Multifocal/Monofocal, Multifocal/Mixed, Bilateral Multifocal,

n = 32 n = 20 n = 52 n = 15

Stereopsis
similar between the two unilateral subgroups
significantly different,
bilateral group (60 30 seconds of arc, test score 7.9 1.6) versus
unilateral supergroup (100 80 seconds of arc, test score 5.9 2.0).
*P < 0.05, multifocal/phakic versus multifocal/monofocal
**P < 0.05, multifocal bilateral versus multifocal/mixed
Results:
Patient Survey of Everyday Tasks
Difficulty of far-distance tasks without spectacles:
no significant differences among any groups

Difficulty of intermediate/near tasks without spectacles

Unilateral versus bilateral multifocal
6 tasks similar between groups: reading a book or newspaper, reading
large print, recognizing people, using a computer, cooking, playing board
games or card games
4 tasks significantly different: performing fine handwork, writing checks or
paying bills, reading small print, reading a restaurant menu in dim light
(all easier for the bilateral group than for the unilateral group)
Unilateral multifocal subgroups: phakic versus monofocal
results for 8 questions were similar between groups
two significant differences
favored phakic group for using a computer
favored monofocal group for reading large print
 Results:
Visual Disturbances
Halos were reported by a smaller proportion of unilateral patients (57%)
than bilateral patients (77%), but difference was not significant
Problems with glare were reported by a larger percentage of
multifocal/phakic patients than multifocal/monofocal patients, likely
due to early cataractous changes in the phakic group

Multifocal/ Multifocal/ Multifocal/ Bilateral

Phakic Monofocal Mixed Multifocal
(n = 32) (n = 20) P (n = 52) (n = 15) P
Report halo 58% 55% 0.83 57% 77% 0.19

Halo rating 1.3 1.3 0.73 1.3 1.4 0.20

Report glare 69% 30% 0.006* 54% 39% 0.32

Glare rating 2.1 2.0 0.33 2.1 2.4 0.46

*Significant at P < 0.05

Halo/glare scale: 1 (not bothersome), 2 (mildly bothersome), 3 (moderately bothersome), 4 (severely bothersome)
 Results:
Patient Satisfaction
A majority of all patients achieved spectacle independence
(60% unilateral, 77% bilateral, no statistical difference)
Almost all patients (>91% in any group) would choose
to have the procedure again
Average rating of satisfaction with vision was higher
in the bilateral group than in the unilateral group
Multifocal/ Multifocal/ Multifocal/ Bilateral
Phakic Monofocal Mixed Multifocal
(n = 32) (n = 20) P (n = 52) (n = 15) P
Spectacle
56% 65% 0.53 60% 77% 0.25
freedom
Would have
91% 95% 0.56 92% 92% 1.00
procedure again
Satisfaction
7.6 6.9 0.24 7.3 8.9 0.001*
with vision

*Significant at P < 0.05

Satisfaction scale: 1 (completely unsatisfied) to 10 (completely satisfied)

 Results:
Distribution of Satisfaction Scores

A majority of patients in all groups (75% to 92%)

were satisfied with their vision (score 7 out of 10)

More bilateral than unilateral patients

rated their vision 8 or 9

100% NS
Percent of patients

* Multifocal/
80% Phakic, n = 32
*
Multifocal/
60% Monofocal, n = 20

40% Multifocal/
Mixed, n = 52
20% Bilateral
Multifocal, n = 13
0%
9 or 10 8 7
Satisfaction rating

Statistically similar proportions of unilateral and bilateral patients

(P = 0.27) rated satisfaction 7 or higher

*P < 0.05, unilateral vs bilateral

NS = not statistically different, unilateral vs bilateral
Conclusions
The unilateral implantation of an aspheric apodized diffractive
multifocal IOL provided patients in this population with
functional near, intermediate, and distance vision
contrast sensitivity that was similar to bilateral ReSTOR patients
spectacle freedom in 60% of cases
vision that 75% of patients rated at satisfaction of 7 or higher (out of 10)

Unilateral multifocal lens implantation

in patients with
a contralateral monofocal or phakic eye
is a viable presbyopia correction option