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Oph halmic Physiol Op . 2022;42:1062–1073.wileyonlinelib a y.com/jou nal/opo
ORIGINAL ARTICLE
Sho - e m ea ilm s abili y, op ical quali y and isual
pe o mance in wo dual- ocus con ac lenses o myopia
con ol wi h di e en op ical designs
José Vicen eGa cía- Ma qués1 | Ru e JulianaMacedo- De- A aújo2 | ColmMcAlinden3,4,5 |
MiguelFa ia- Ribei o2 | Alejand oCe iño1 | José ManuelGonzález- Méijome2
Recei ed: 22 Feb ua y 2022
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Accep ed: 20 June 2022
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Published online: 8 July 2022
DOI: 10.1111/opo.13024
This is an open access a icle unde he e ms o he C ea i e Commons A ibu ion License, which pe mi s use, dis ibu ion and ep oduc ion in any medium, p o ided
he o iginal wo k is p ope ly ci ed.
© 2022 The Au ho s. Oph halmic and Physiological Op ics published by John Wiley & Sons L d on behal o College o Op ome is s.
1Op ome y Resea ch G oup, Depa men o
Op ics and Op ome y and Vision Sciences,
Uni e si y o Valencia, Valencia, Spain
2Clinical and Expe imen al Op ome y
Resea ch Labo a o y (CEORLab) Cen e o
Physics (Op ome y), School o Sciences,
Uni e si y o Minho, B aga, Po ugal
3Depa men o Oph halmology, Royal
Gwen Hospi al, Newpo , UK
4Wenzhou Medical Uni e si y, Wenzhou,
China
5Eye & ENT Hospi al o Fudan Uni e si y,
Shanghai, China
Co espondence
Jose Vicen e Ga cía- Ma qués, Op ome y
Resea ch G oup, Depa men o Op ics and
Op ome y and Vision Sciences, Uni e si y o
Valencia, Valencia, Spain.
Email: jose. icen e.ga cia@u .es
Funding in o ma ion
Fundacao pa a a Ciencia e a Tecnologia,
G an /Awa d Numbe : UID/FIS/04650/2013,
PTDC/FIS- OPT/0677/2014 and PTDC/SAU-
BEB/098391/2008; Uni e si a de Valencia
Abs ac
Pu pose: To assess and compa e sho - e m isual and op ical quali y and ea ilm
s abili y be ween wo dual- ocus (DF) p o o ype myopia con ol con ac lenses
(CLs) ha ing di e en inne zone diame e s.
Me hods: Twen y- eigh myopic subjec s we e included in his andomised,
double- masked c osso e s udy. Re ac ion, bes - co ec ed isual acui y (VA) and
ea ilm s abili y we e measu ed a baseline (i.e., when unco ec ed). Subjec s
we e hen binocula ly i ed wi h he DF CLs, wi h only he senso ial dominan eye
being assessed. Lenses we e o he same ma e ial and had inne zone diame e s o
ei he 2.1 mm (S design) o 4.0 mm (M design). Visual and physical sho - e m lens
com o , o e - e ac ion, bes - co ec ed VA, s e eopsis a 40 cm, bes - co ec ed
pho opic and mesopic con as sensi i i y (CS), size and shape o ligh dis u bance
(LD), wa e on abe a ions, subjec i e quali y o ision (QoV Ques ionnai e) and
ea ilm s abili y we e measu ed o each lens.
Resul s: Bo h CL designs dec eased ea ilm s abili y compa ed wi h baseline
(p< 0.05). VA and pho opic CS we e wi hin no mal alues o he subjec s' age wi h
each CL. When compa ing lenses, he M design p omo ed be e pho opic CS o he
18 cycles pe deg ee spa ial equency (p< 0.001) and be e LD (p< 0.02). Howe e ,
highe - o de abe a ions we e imp o ed wi h he S design (p= 0.02). No signi ican
di e ence be ween he wo CLs was ound o QoV sco es and ea ilm s abili y.
Conclusions: Bo h DF CLs p o ided accep able isual pe o mance unde pho-
opic condi ions. The 4.0 mm inne zone ga e be e con as sensi i i y a high e-
quencies and lowe ligh dis u bance, while he 2.1 mm cen al diame e induced
ewe highe - o de abe a ions o a 5 mm pupil diame e . Bo h CLs p oduced he
same subjec i e isual sho - e m lens com o .
KEYWORDS
ligh dis u bance, mul i ocal con ac lens, myopia con ol, ea ilm s abili y, isual pe o mance,
isual quali y
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1063
GARCÍA- MARQUÉS e Al.
INTRODUCTION
The p e alence o myopia has inc eased d ama ically o e
he pas 60 yea s.1– 3 A numbe o me hods o con ol my-
opia p og ession in he paedia ic popula ion ha e been
de eloped, including cen al dis ance and dual- ocus (DF)
con ac lenses (CL).4 These lenses induce pe iphe al de-
ocus o educe o - axis hype opia, he eby a enua ing a
po en ial s imulus o axial elonga ion.1– 10 I has been e-
po ed ha DF CLs ha e an e icacy be ween 30% and 72%
o con olling he sphe ical equi alen e ac i e e o , and
up o 80% o con olling axial leng h.8,11– 15
Despi e hei posi i e e ec on con olling eye g ow h,
DF CLs ha e he d awback o limi ing e inal image qual-
i y since he ligh ha en e s he pupil is edis ibu ed in o
di e en oci.3,16– 18 Gene ally, DF CLs cause a educ ion in
con as sensi i i y and induce g ea e ligh dis u bance
and highe - o de abe a ions.1,3,7,16,18,19 These e ec s may
be pupil- dependen since he pe cen age o ligh dis ib-
u ed a he a and nea ocus depends upon he pupil di-
ame e . The e o e, he pe o mance o a DF CL is in luenced
by he zones designed o a and nea ision and he pupil
diame e exposed o hese zones.19– 25 I has also been e-
po ed ha isual quali y and pa ien sa is ac ion migh be
imp o ed by adjus ing he dis ance and nea zones o he
lens.1,8,20,26 Fo ins ance, Ma ins e al.1 and Talens- Es a elles
e al.20 ound ha he quali y o ision was less a ec ed by
lenses wi h la ge dis ance ision a eas. Howe e , di e en
ypes o CLs we e used in hese in es iga ions.
Ano he majo con ibu ion o he image quali y pe -
cei ed h ough a CL, i espec i e o whe he i is DF, is ea
ilm quali y. The ea ilm plays an impo an ole in he i -
ing and com o o CLs, and he isual quali y o he eye.
The e o e, assessing he ea ilm in CL wea e s is i al.27,28
When a CL is i ed, i spli s he ea ilm in o p e- lens and
pos - lens laye s, which may make he ea ilm less s a-
ble.28– 30 A ecen s udy28 epo ed ha he concen ic ing
pa e n o a DF CL o myopia con ol induced a educ ion
in he ea ilm s abili y and com o when compa ed o a
mono ocal lens composed o he same ma e ial. This may
be caused by he educed sp eading o he p e- lens ea
ilm ac oss he CL su ace due o he ab up changes in he
cu a u e o he an e io lens su ace. The p esen s udy
ex ends his wo k by assessing whe he he di e en inne
zones wi hin he concen ic ing pa e n o a DF CL also a -
ec ea ilm s abili y.
To ou knowledge, only a ew s udies o da e ha e as-
sessed he in luence o myopia con ol CLs on isual qual-
i y and ea ilm s abili y.1,8,16,28 Since isual quali y, com o
and he ea ilm play a ole in CL i ing and ea men ad-
he ence, expanding knowledge on how di e en designs
and ma e ials a ec hese clinical pa ame e s is highly
ele an .31
In his s udy, we compa ed sho - e m isual quali y,
op ical quali y, ligh dis u bance, sho - e m lens com o
and ea ilm s abili y be ween wo p o o ype myopia con-
ol DF CLs, manu ac u ed om he same ma e ial.8 We
hypo hesised ha hese pa ame e s may be in luenced by
he di e en CL designs. The p esen s udy may help clini-
cians adjus lens designs based on he pa ien 's needs o
imp o e adhe ence and sa is ac ion wi h DF CLs.
METHODS
Twen y- eigh heal hy myopic olun ee s aged be ween
18 and 32 yea s old we e en olled in his compa a i e, an-
domised, double- masked, c osso e s udy. W i en con-
sen was ob ained a e an explana ion o he pu pose and
he p o ocol o he s udy. The me hodology ollowed he
ene s o he Decla a ion o Helsinki and was app o ed
by he E hics Subcommi ee o Li e and Heal h Sciences
o he Uni e si y o Minho, Po ugal. All subjec s had bes -
co ec ed VA o 0.00 logMAR o be e in each eye. Subjec s
wi h any ocula disease, binocula anomaly, as igma ism
>0.75D7 o who we e aking any medica ion ha con ain-
dica ed he use o CLs we e excluded om he s udy. P io
CL wea was no conside ed. Regula CL wea e s we e in-
s uc ed no o wea hei CLs o a week be o e he ials.
Expe imen al p ocedu e
The p o ocol consis ed o wo isi s. A he i s isi (base-
line isi ), case his o y, subjec i e e ac ion wi h ial
lenses, isual acui y and p e- co neal ea ilm s abili y we e
assessed. The powe o he CLs o be used (ei he −2.00 D,
−3.50 D o −5.00 D) was chosen based on he subjec i e e-
ac ion esul s. Since only h ee powe s we e a ailable, he
powe ha was closes o he e ac ion o he subjec was
chosen. A he second isi , each pai o DF CLs we e i ed
(binocula ly) in andom o de and hese pa ame e s we e
assessed in he ollowing o de : o e - e ac ion wi h ial
lenses, quali y o ision (QoV) ques ionnai e, sho - e m
lens com o assessmen , isual acui y, s e eopsis, pho-
opic and mesopic con as sensi i i y, ligh dis u bance
assessmen , abe a ions and p e- lens ea ilm s abili y.
Only esul s om he senso ial dominan eye we e in-
cluded since we aimed o assess he e ec o CL design on
Key poin s
• The 4.0 mm cen al diame e con ac lens p o-
ided be e con as sensi i i y a highe spa ial
equencies and lowe ligh dis u bance han
he 2.1 mm cen al diame e lens.
• The 2.1 mm cen al diame e con ac lens-
induced lowe le els o highe - o de abe a ions
han he 4.1 mm cen al diame e lens.
• Nei he he sho - e m subjec i e isual com o
no he ea ilm s abili y was in luenced by he
cen al diame e o he lens.
1064
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PERFORMANCE OF TWO CLS WITH DIFFERENT DESIGNS
isual pe o mance wi hou conside ing o he ac o s such
as binocula summa ion. Ne e heless, bo h eyes we e
i ed wi h CLs o make he condi ions as ealis ic as pos-
sible. Senso ial dominance was ob ained by means o he
‘+1.50 D blu ’ me hod. Subjec s we e ins uc ed o look bin-
ocula ly a he smalles de ec able line on he le e cha .
A +1.50D sphe ical ial lens was held be o e one eye o a
ew seconds, emo ed and hen placed be o e he o he
eye. The dominan eye was aken as he one expe iencing
he g ea e isual dis up ion.32,33
Dual- ocus con ac lenses
The p o o ype CLs had a cen e dis ance inne zone o ei-
he 2.1 mm o 4.0 mm in diame e , su ounded by al e na -
ing zones wi h +2.0 D add powe (Figu es1 and 2).1,8,14,34
CL pa ame e s a e summa ised in Table1. The lenses we e
manu ac u ed by P ecilens (P ecilens, p eci lens.com). The
op ical design was he only di e ence be ween he CLs.
The smalle cen al diame e (S design) had an inne cen-
al zone o 2.1 mm, while he medium cen al diame e (M
design) had an inne zone diame e o 4.0 mm.
The mo emen and cen a ion o each CL we e assessed
using a sli lamp. Measu emen s began 25 min a e CL
inse ion o allow o lens se ling.7 A wash- ou pe iod o
15 min was allowed be ween he CLs.1,35 Du ing his in e -
lens pe iod, subjec s we e asked o emain in he labo a-
o y so ha di e ences in ligh , empe a u e o humidi y
did no a ec he second CL measu emen s. A he end o
he isi , subjec s we e asked o choose hei p e e ed CL.
Measu emen s
O e - e ac ion was pe o med using an open ield binoc-
ula au o e ac o (G and Seiko Au o e ac ome e WAM-
5500, g and seiko.com) and hen adjus ed subjec i ely wi h
sphe ical lenses. The end- poin c i e ion o maximum plus
o bes isual acui y was used.36 This o e - e ac ion, in
he o m o ial lenses, was e ained h oughou he es
o he p o ocol, excep o he measu emen o abe a-
ions. A plano ial lens was in oduced i no o e - e ac ion
was needed, so ha all subjec s we e measu ed unde he
same condi ions. A e assessing he o e - e ac ion, sub-
jec s wo e hese ial lenses o 25 min un il he measu e-
men s began, since only h ee CL powe s we e a ailable.
Subjec i e quali y o ision was assessed using he QoV
ques ionnai e,32,37,38 which includes 10 ques ions abou i-
sual symp oms: gla e, haloes, s a bu s , hazy ision, blu ed
ision, dis o ion, double o mul iple images, luc ua ion in
ision, ocusing di icul ies and di icul y in- dep h pe cep-
ion. The ques ionnai e is sco ed on a Rasch scale om 0 o
100 depending on he equency, se e i y and how bo h-
e some he symp oms we e. Lowe sco es indica e a be e
subjec i e quali y o ision.32,37
Gene al, physical and isual sho - e m lens com o
we e assessed using con inuous isual analogue scales
(VAS) be ween 0 and 10. Lowe sco es indica e be e com-
o . Subjec s we e asked i s abou he gene al com o ,
ollowed by physical and isual com o : ‘How do you a e
you o e all com o wi h he lens?’; ‘How do you a e you
physical com o (pain, o eign body sensa ion, g i y sen-
sa ion, d yness, i ching…) wi h he lens?’; ‘How do you a e
you isual com o (blu ed ision, dis o ion o halos,
gla e and la e a ound ligh s) wi h he lens?’
Pho opic isual acui y was measu ed using he
Loga i hmic Visual Acui y Cha 2000 (P ecision Vision,
p eci sion- ision.com). The Rando S e eo es (S e eo
Op ical, s e e oop i cal.com) was used o assess s e eopsis
a 40 cm. Mo eo e , a Vision Con as Tes Sys em VCTS
6500 was used o measu e bes - co ec ed pho opic and
mesopic con as sensi i i y a 3m.39 The a ea unde he
con as sensi i i y cu e was calcula ed using apezoidal
nume ical in eg a ion. Pho opic condi ions we e consid-
e ed ≥3cd/m2 and he mesopic ange om 0.01 o 3cd/
m2. Pupil diame e s we e measu ed om he G and Seiko
au o e ac ome e WAM- 5500.
FIGURE 1 Powe p o ile o he con ac lens wi h he small (2.1 mm) diame e o cen al dis ance nominal powe s o −2.00 D, −3.50 D and −5.00 D.
-6.00
-5.00
-4.00
-3.00
-2.00
-1.00
0.00
1.00
-2.96
-2.74
-2.52
-2.30
-2.08
-1.86
-1.64
-1.41
-1.19
-0.97
-0.75
-0.53
-0.31
-0.09
0.16
0.38
0.60
0.83
1.05
1.27
1.49
1.71
1.93
2.15
2.37
2.59
2.81
Powe (D)
Radial Dis ance (mm)
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1065
GARCÍA- MARQUÉS e Al.
Ligh dis u bance is a phenomenon c ea ed by he ligh
om a cen al luminous poin causing a halo su ounding
he ligh sou ce. This is an indica o o isual quali y. Ligh
dis u bance was assessed monocula ly using he Ligh
Dis o ion Analyse (LDA, CEORLab, ceo l ab.wixsu e.com);
a de ice de eloped a he Physics Depa men , Uni e si y
o Minho. I measu es he size and shape o he ligh dis-
u bance su ounding a cen al b igh ligh sou ce. Se e al
s udies ha e epo ed ha he LDA can assess ligh dis u -
bance success ully unde dim ligh condi ions.16,17,32,36,40,41 A
de ailed desc ip ion o he sys em, ligh sou ces and mea-
su ing p ocedu e can be ound in p e ious wo k.32,42 In he
p esen in es iga ion, semi- me idians wi h an angula sepa-
a ion o 30 deg ees we e measu ed using an in- ou ou ine.
Se e al me ics ela ed o he size and shape o he ligh
dis u bance we e calcula ed. The dis u bance a ea was
de ined as he sum o he semi- me idian a eas assessed
in mm2. The Ligh Dis u bance Index (LDI) exp esses he
pe cen age o he o al a ea co e ed by he ligh dis o -
ion and is he a io o he a ea o poin s missed by he
subjec o he o al a ea explo ed. The bes - i ci cle adius
desc ibes he ci cle ha bes i s he dis u bance a ea, ex-
p essed in millime es. The de ia ion o he ob ained po-
lygonal shape om he bes - i ci cle is he bes - i ci cle
i egula i y, while he s anda d de ia ion o he bes - i
ci cle i egula i y measu es he asymme y o he ligh dis-
u bance shape om he pe ec ci cula shape o he bes -
i ci cle and indica es he ligh dis u bance i egula i y.32,36
Pupil diame e was measu ed in he con ala e al eye while
subjec s we e pe o ming he ask using a Neu Op ics®
VIP™- 200 Pupillome e (Neu Op ics, neu o p ics.com).
A Ha mann- Shack Abe ome e (i x3™, Imagine Eyes,
imagi ne- eyes.com) was used o measu e ocula abe a-
ions and econs uc hem using Ze nike polynomials o
pupil diame e s o 3 and 5 mm. These diame e s we e cho-
sen in line wi h p e ious s udies.43– 45 Roo mean squa e
(RMS) was calcula ed wi h he CL in si u o lowe - o de ab-
e a ions (LOAs), highe - o de abe a ions (HOAs) up o he
9 h o de and o al abe a ions.
Finally, he Medmon E 300, e sion 6.1 (Medmon ,
medmo n .com.au) was used o assess Tea Film Su ace
Quali y (TFSQ). TFSQ is a p e iously alida ed algo i hm,
which has been epo ed o p edic ea ilm s abili y46 and
o be able o disce n be ween d y and non- d y eyes.47 I
analyses he s uc u e o he Placido disk pa e n e lec ed
on o he ea ilm a e blinking o e ime. TFSQ alues
ange om 0 o 1. A alue ≥0.30 indica es a des abilised
ea ilm wi h dis o ions in he ing pa e n. G ea e TFSQ
sco es ep esen a less egula ea ilm.46,47 Th ee me ics
a e au oma ically calcula ed by he de ice: TFSQ, TFSQ
a ea and au o Tea B eak- Up Time. TFSQ a ea co esponds
o he pe cen age o he a ea assessed wi h a TFSQ alue
>0.30, while au o Tea B eak- Up Time is he ime in sec-
onds in which he TFSQ a ea is a leas 5.0% in wo consec-
u i e images.46,47 Tea ilm s abili y was measu ed o 30 s
on h ee consecu i e occasions, and he mean and median
we e calcula ed o each measu emen . Room empe a-
u e and humidi y emained s able du ing all isi s.
Luminance and illuminance we e e alua ed using a lu-
minance me e (LS- 100, Konica Minol a, konic amino l a.
com) and an illuminance me e (T- 10, Konica Minol a, konic
amino l a.com), espec i ely. The a ying dayligh was e-
mo ed by using blackou cu ains in he examina ion oom.
Room illuminance was 255.58 ± 8.22 and 3.52 ± 0.12 lux
FIGURE 2 Powe p o ile o he con ac lens wi h he medium (4.0 mm) diame e o cen al dis ance nominal powe s o −2.00 D, −3.50 D
and −5.00 D.
-6.00
-5.00
-4.00
-3.00
-2.00
-1.00
0.00
-2.96
-2.74
-2.52
-2.30
-2.08
-1.86
-1.64
-1.41
-1.19
-0.97
-0.75
-0.53
-0.31
-0.09
0.16
0.38
0.60
0.83
1.05
1.27
1.49
1.71
1.93
2.15
2.37
2.59
2.81
Powe (D)
Radial Dis ance (mm)
TABLE 1 Pa ame e s o each con ac lens
Design S Design M
Inne zone (mm) 2.1 4.0
Add powe (D) +2.0 +2.0
Ma e ial Filcon V3 Filcon V3
Dk 60 uni s 60 uni s
Base cu e (mm) 8.6 8.6
Lens diame e (mm) 14.0 14.0
No e: Dk=pe meabili y; S=con ac lens wi h a small (2.1 mm) cen al dis ance
diame e ; M=con ac lens wi h a medium (4.0 mm) cen al dis ance diame e .
1066
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PERFORMANCE OF TWO CLS WITH DIFFERENT DESIGNS
unde pho opic and mesopic condi ions, espec i ely. The
mean luminance was 203.10± 3.68 cd/m2, 48.09 ± 1.15 cd/
m2 and 0.63 ± 0.01 cd/m2 o he measu emen o isual
acui y, pho opic and mesopic con as sensi i i y a 3m,
espec i ely.
S a is ical analysis
SPSS 26.0 s a is ical so wa e o Mic oso Windows (IBM,
ibm.com) was used o pe o m he s a is ical analysis. The
Shapi o– Wilk es was used o check da a o no mali y.
Resul s we e epo ed as median and in e qua ile anges
i hey we e no no mally dis ibu ed.
Di e ences be ween he wo CLs o each pa ame e
we e e alua ed wi h he pai ed - es o Wilcoxon signed-
ank es , depending upon he sample dis ibu ion.
Di e ences be ween each CL and baseline o he ea ilm
analysis we e e alua ed using ei he analysis o a iance
(ANOVA) o he F iedman es . Pos - hoc pai wise compa -
isons we e ca ied ou using Bon e oni co ec ion. The
in e ac ion be ween CL ype and he o de in which hey
we e i ed was assessed by means o a mixed ANOVA. P-
alues < 0.05 we e conside ed s a is ically signi ican .
RESULTS
Twen y- eigh eyes om 28 subjec s (17 emale and 11 male)
we e included, 20 o whom we e CL wea e s. The mean age
was 23.5± 4.1 yea s, anging om 18 o 32 yea s. Median
sphe ical e ac ion was −1.00 D (in e qua ile ange: −2.31
o −0.27 D), while median as igma ism was 0.00 D (in e -
qua ile ange: −0.50 o 0.00 D).
Eigh een subjec s we e i ed wi h a CL ha ing a dis-
ance nominal powe o −2.00 D, six wi h −3.50 D and ou
wi h −5.00 D. A e lens i ing, he median sphe ical o e -
e ac ion was +1.00 D (in e qua ile ange: +0.50 o +1.25
D) and +1.00 D (in e qua ile ange: +0.56 o +1.25 D) o
he small and medium diame e inne op ic zones, espec-
i ely. The CLs we e conside ed o ha e accep able mo e-
men , cen a ion and co e age in all subjec s.
Visual acui y, s e eopsis and con as
sensi i i y
Dis ance bes - co ec ed isual acui y, s e eopsis and bes -
co ec ed con as sensi i i y unde pho opic and mes-
opic condi ions o each CL design a e shown in Table2.
The majo i y o subjec s (60.7%) wea ing he S design
achie ed s e eopsis o 20 s o a c and 39.3% achie ed be-
ween 20 and 25 s o a c. Wi h he M design, 50% o sub-
jec s achie ed s e eopsis o 20 s o a c, 46.4% be ween 20
and 25 s o a c and 3.6% be ween 25 and 40 s o a c.
No signi ican di e ences we e ound be ween he wo
DF CLs o isual acui y, s e eopsis, pho opic and mesopic
con as sensi i i y, excep o pho opic con as sensi-
i i y a a spa ial equency o 18 cycles pe deg ee (cpd)
(p< 0.001), whe e con as sensi i i y was highe wi h he
M design.
The con as sensi i i y unc ion ollowed a no mal
physiological shape wi h he highes sensi i i y a 3cpd
(Figu e3). Bo h CLs showed simila pe o mance unde
bo h pho opic and mesopic condi ions. Pho opic con-
as sensi i i y cu es we e wi hin he no mali y zone39
o all spa ial equencies, excep o he S design a 6cpd.
Howe e , mesopic con as sensi i i y ell below he no -
mali y zone a all spa ial equencies wi h bo h CLs.
The mean pupil diame e unde pho opic condi ions
was 4.44 ± 0.43 mm and 4.45 ± 0.42 mm o he S and M de-
signs, espec i ely ( 27= −0.96, p=0.39). The mean pupil di-
ame e unde mesopic condi ions was 6.39 ± 0.38 mm and
6.36 ± 0.35 o he S and M designs, espec i ely ( 27= −1.16,
p=0.24). Pupil diame e was signi ican ly la ge unde me-
sopic condi ions o he S ( 2 7 = −13.73, p< 0.001) and M
design ( 27= −16.92, p< 0.001).
Ligh dis u bance
Table3 shows ligh dis o ion indings o each CL design.
Dis u bance a ea, ligh dis o ion index and bes - i ci cle
adius we e signi ican ly highe o he S design han o
he M design (p≤ 0.02). Ne e heless, no signi ican di e -
ences be ween he CLs we e ound in he i egula i y o
he ligh dis o ion (bes - i ci cle i egula i y and s anda d
de ia ion o bes - i ci cle i egula i y). Mean pupil diam-
e e o he S and M CLs while subjec s we e being assessed
o LDA was 5.20 ± 0.76 and 5.15 ± 0.79 mm, espec i ely
( 27= 0.29, p=0.82).
Wa e on abe a ions
Table4 shows LOA, HOA and o al abe a ions wi h 3 and
5 mm pupil diame e s o each CL. No signi ican di e ences
be ween CLs we e ound o LOA and o al abe a ions. Fo
he CL measu emen s, subjec s we e co ec ed wi h a lens
o simila powe o he subjec 's e ac i e e o , i.e., −2.00
D, −3.50 D o −5.00 D. Thus, compa isons o bo h LOA and
o al abe a ions we e ela ed o he esidual e ac i e e o
o he subjec s.48 Howe e , HOA we e no ela ed o he e-
sidual e ac i e e o and he e o e can be used o compa e
he abe a ions induced by he DF design. The M design
showed s a is ically highe le els o HOA o a 5 mm pupil
diame e , compa ed wi h he S design. No o he signi ican
di e ences we e obse ed be ween he lenses.
Tea ilm s abili y
Resul s o ea ilm s abili y a baseline (p e- co neal ea
ilm s abili y) and o each CL (p e- lens ea ilm s abili y)

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1067
GARCÍA- MARQUÉS e Al.
a e shown in Table5. Tea ilm s abili y was poo e when
subjec s we e wea ing ei he CL (highe TFSQ and TFSQ
a ea and lowe au o Tea B eak- Up Time) when compa ed
wi h baseline. Howe e , no signi ican di e ences we e
ound be ween he CLs o he ea ilm s abili y, which
sugges s ha a ia ions in he diame e o he CL inne
zone do no cause changes in ea ilm s abili y.
Ques ionnai es
Table6 shows he esul s om he QoV ques ionnai e. No
signi ican di e ences we e ound be ween he wo CLs
o QoV alues in he equency, se e i y and bo he some
subscales. Table7 shows he esul s o sho - e m lens
com o . Sco es did no di e signi ican ly be ween he
CL designs o o e all, physical and isual sho - e m lens
com o . Finally, 13 subjec s (46.4%) p e e ed he S design
CL, whils 15 subjec s (53.6%) p e e ed he M design CL.
No signi ican in e ac ion was ound be ween CL ype
and he o de in which he lenses we e i ed o any o he
pa ame e s epo ed he e (all p> 0.42). Thus, he o de o
lens i ing was no a con ounding ac o in he esul s.
DISCUSSION
DF CLs a e pupil- dependen , and hei pe o mance is
in luenced by he a io be ween he dis ance and added
powe zones, and he a ea o he pupil exposed o hese
zones.8,19– 25,49,50 Thus, wide cen al diame e s ha e he
added powe loca ed u he away om he cen e o he
TABLE 2 Bes - co ec ed dis ance isual acui y, s e eopsis and bes - co ec ed pho opic and mesopic con as sensi i i y o each CL design
Measu emen Condi ion Median (In e qua ile ange)
Signi icance le el
(S a is ic, p- alue)
Bes - co ec ed dis ance isual acui y (LogMAR) S −0.05 (0.00 o −0.10) ( 27= −0.98, p=0.38)a
M −0.10 (−0.02 o −0.10)
S e eopsis (seconds o a c) S 22.0 (20 o 25) (Z27= 1.51, p=0.13)b
M 22.5 (20 o 25)
Pho opic con as sensi i i y 1.5cpd (db) S 35 (35 o 70) (Z27=−1.14, p=0.25)b
M 35 (23.75 o 35)
Pho opic con as sensi i i y 3cpd (db) S 85 (85 o 170) (Z27=−1.04, p=0.30)b
M 85 (54.25 o 170)
Pho opic con as sensi i i y 6cpd (db) S 45 (45 o 111.25) (Z27= 1.14, p=0.26)b
M 70 (45 o 70)
Pho opic con as sensi i i y 12 cpd (db) S 23.50 (15 o 32) (Z27= 0.79, p=0.43)b
M 32 (15 o 55)
Pho opic con as sensi i i y 18 cpd (db) S 5.50 (4 o 10) (Z27= 3.88, p< 0.001)b,c
M 10 (10 o 15)
A ea unde he pho opic con as sensi i i y cu e S 577.5 (522 o 1157.63) (Z27= 1.02, p=0.35)b
M 754.5 (462.38 o 1098.75)
Mesopic con as sensi i i y 1.5cpd (db) S 20 (20 o 20) (Z27= 0.12, p=0.90)b
M 20 (20 o 20)
Mesopic con as sensi i i y 3cpd (db) S 24 (24 o 44) (Z27=−0.97, p=0.33)b
M 24 (24 o 44)
Mesopic con as sensi i i y 6cpd (db) S 11 (6.5 o 21) (Z27=−1.63, p=0.10)b
M 21 (11 o 21)
Mesopic con as sensi i i y 12 cpd (db) S 5 (0 o 5) (Z27= 0.29, p=0.77)b
M 5 (5 o 7.25)
Mesopic con as sensi i i y 18 cpd (db) S 0 (0 o 4) (Z27= 1.64, p=0.10)b
M 0 (0 o 4)
A ea unde he pho opic con as sensi i i y cu e S 148.5 (98.25 o 250.5) (Z27= 1.08, p=0.38)b
M 193.5 (148.5 o 264.0)
No e: S=con ac lens wi h he small (2.1 mm) cen al dis ance ing diame e ; M=con ac lens wi h he medium (4.0 mm) cen al dis ance ing diame e .
aT- es .
bWilcoxon.
cS a is ically signi ican di e ences; cpd=cycles pe deg ee; dB=decibel.
1068
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PERFORMANCE OF TWO CLS WITH DIFFERENT DESIGNS
isual ield, which causes less impai men o cen al ision.2
To in es iga e he in luence o he inne zone diame e on
isual pe o mance, wo p o o ype DF CLs designed o e-
duce myopia p og ession we e assessed in his s udy.
Visual acui y, s e eopsis and con as
sensi i i y
The esul s demons a e ha bo h CLs p o ided excel-
len isual acui y and s e eopsis, wi h no signi ican di -
e ences be ween he lenses. Values o isual acui y,
s e eopsis and con as sensi i i y we e simila o he e-
sul s ound in a p e ious s udy wi h a di e en DF CL.16
Talens- Es a elles e al.20 and Ma ins e al.1 epo ed be e
dis ance isual acui y in CLs wi h la ge a eas o dis ance
ision. Fu he , P zeko acka e al.2 ound ha a myopia
con ol CL wi h a cen al zone o 3 mm, +4.00 D Add and
a polynomial p og ession zone educed dis ance isual
acui y in compa ison wi h a CL wi h a 4.5 mm cen al zone.
Howe e , hey did no obse e any educ ion wi h a +2.00
Add. Addi ionally, he au ho s ound ha bo h diame e s
a ec ed con as sensi i i y by he same amoun , which
sugges s ha e en medium- dis ance cen al diame e s
FIGURE 3 Bes - co ec ed con as sensi i i y unc ion o each con ac lens design unde pho opic and mesopic condi ions. S=small (2.1 mm)
cen al diame e ; M=medium (4.0 mm) cen al diame e .
TABLE 3 Ligh dis u bance o each CL
Measu emen Lens Median (In e qua ile ange)
Signi icance le el
(S a is ic, p- alue)
Dis u bance a ea (mm2) S 3384 (2396– 5504) (Z27=−2.46, p=0.01)a,b
M2744 (1852– 4148)
Ligh dis o ion index (%) S 16.83 (11.92– 27.38) (Z27=−2.44, p=0.01)a,b
M13.65 (9.21– 20.63)
Bes - i ci cle adius (mm) S 33.30 (28.18– 42.65) (Z27=−2.39, p=0.02)a,b
M30.00 (24.85– 36.98)
Bes - i ci cle i egula i y (mm) S0.71 (0.37– 0.98) (Z27=−0.08, p=0.94)b
M0.79 (0.34– 1.03)
Bes - i ci cle i egula i y SD (mm) S4.86 (4.06– 7.65) (Z27=−1.48, p=0.14)b
M4.78 (3.15– 5.95)
No e: S=con ac lens wi h he small (2.1 mm) cen al dis ance ing diame e ; M=con ac lens wi h he medium (4.0 mm) cen al dis ance ing diame e .
aWilcoxon.
bS a is ically signi ican di e ences; mm=millime es.
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1069
GARCÍA- MARQUÉS e Al.
may impai con as sensi i i y. These esul s a e in line
wi h he esul s o he p esen s udy using a +2.00 D Add.
The e o e, isual acui y migh ha e been a ec ed had a
highe add powe been used. Howe e , hese s udies a e
no di ec ly compa able due o di e ences in me hodol-
ogy and lenses used.
Pho opic con as sensi i i y cu es lay inside he no -
mali y zone39 o all spa ial equencies excep o he S de-
sign a 6cpd. Ne e heless, young subjec s we e expec ed
o lie nea he op o he no mali y zone. Pho opic con as
sensi i i y o he 18 cpd spa ial equency was be e wi h
he M design (p < 0.001). This is in acco dance wi h he
TABLE 4 Lowe - o de , highe - o de and o al abe a ions o pupil diame e s o 3 and 5 mm o each condi ion
Measu emen Condi ion Median (In e qua ile ange)
Signi icance le el
(S a is ic, p- alue)
Lowe - o de 3 mm RMS (μm) S0.30 (0.19– 0.39) (Z27= 1.79, p=0.08)a
M0.37 (0.27– 0.50)
Highe - o de 3 mm RMS (μm) S0.23 (0.19– 0.25) ( 27= 0.47, p=0.64)b
M0.22 (0.17– 0.27)
To al abe a ions 3 mm RMS(μm) S0.38 (0.31– 0.45) (Z27= 1.82, p=0.07)a
M0.44 (0.32– 0.52)
Lowe - o de 5 mm RMS (μm) S0.55 (0.36– 0.81) (Z27= 0.44, p=0.66)a
M0.42 (0.30– 0.93)
Highe - o de 5 mm RMS (μm) S0.37 (0.33– 0.42) (Z27= 3.81, p< 0.001)a,b
M0.51 (0.44– 0.54)
To al abe a ions 5 mm RMS (μm) S0.63 (0.55– 0.89) (Z27= 1.92, p=0.06)a
M0.69 (0.60– 1.05)
No e: S=con ac lens wi h he smalle (2.1 mm) cen al dis ance ing diame e ; M=con ac lens wi h he medium (4.0 mm) cen al dis ance ing diame e .
aWilcoxon.
bT- es .
cS a is ically signi ican di e ences; μm=mic ome es; RMS= oo mean squa e.
TABLE 5 Tea Film Su ace Quali y (TFSQ) me ics o each expe imen al condi ion
Measu emen Condi ion
Median (In e qua ile
ange)
Signi icance le el
(S a is ic, p- alue) Pos - hoc (p- alue)
Mean TFSQ Baseline 0.13 (0.08– 0.20) <0.001a,cBaseline- S: <0.001b,c
S0.37 (0.26– 0.45) Baseline- M: <0.001b,c
M0.38 (0.31– 0.51) S- M: 0.54b
Median TFSQ Baseline 0.10 (0.07– 0.17) <0.001a,cBaseline- S: <0.001b,c
S0.36 (0.23– 0.43) Baseline- M: <0.001b,c
M0.38 (0.32– 0.53) S- M: 0.54b
Mean TFSQ a ea (%) Baseline 7.17 (1.44– 14.37) <0.001a,cBaseline- S: <0.001b,c
S32.20 (23.84– 46.18) Baseline- M: <0.001b,c
M37.10 (27.20– 52.36) S- M: 1.00b
Median TFSQ a ea (%) Baseline 4.10 (0.87– 12.85) <0.001a,cBaseline- S: <0.001b,c
S32.90 (21.78– 44.75) Baseline- M: <0.001b,c
M38.45 (25.60– 54.08) S- M: 0.43b
Mean au o ea b eak- up ime (seconds) Baseline 7.12 (4.73– 11.46) <0.001a,cBaseline- S: <0.001b,c
S2.54 (2.40– 2.60) Baseline- M: <0.001b,c
M2.47 (2.40– 2.56) S- M: 1.00b
Median au o ea b eak- up ime (seconds) Baseline 6.89 (4.73– 10.74) <0.001a,cBaseline- S: <0.001b,c
S2.50 (2.40– 2.60) Baseline- M: <0.001b,c
M2.50 (2.40– 2.60) S- M: 1.00b
No e: Baseline=no lens p esen ; S=con ac lens wi h an inne zone diame e o 2.1 mm; M=con ac lens wi h an inne zone diame e o 4.0 mm;
aF iedman.
bBon e oni.
cS a is ically signi ican di e ences; TFSQ= ea ilm su ace quali y.
1070
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PERFORMANCE OF TWO CLS WITH DIFFERENT DESIGNS
esul s o Ma ins e al.1 and Talens- Es a elles e al.,20 who
ound ha subjec s i ed wi h designs ha ing la ge inne
zone diame e s showed be e con as sensi i i y a bo h
medium and high spa ial equencies.
Va ious s udies ha e ound poo e con as sensi i i y
a high spa ial equencies in eyes i ed wi h mul i ocal
CLs.1,2,16,35,51,52 Conside ing ha bo h DF and mul i ocal
CLs ha e zones o powe ha o e co ec he dis ance e-
ac i e e o , hese supe imposed ou - o - ocus images will
c ea e eiling on he e ina and dec ease con as modula-
ion.21,52,53 The e o e, i is expec ed o ind a be e quali y
o ision a dis ance wi h designs ha ha e a highe con i-
bu ion o he dis ance co ec ion.
Ligh dis u bance
P e ious s udies1,32,41 ound mo e ligh dis u bance wi h
mul i ocal compa ed wi h single- ision CLs, which ended
o wo sen wi h lenses ha ing smalle zones o dis ance
ision. In his s udy, he size o he ligh dis u bance was
g ea e o he S design. Ne e heless, he shape o he ligh
dis u bance was no a ec ed. These indings a e aligned
wi h a p e ious s udy1 ha ound less ligh dis u bance
wi h myopia con ol lenses ha ing la ge a eas o dis ance
ision, wi hou di e ences in he shape o he halo. This
migh be explained by he ac ha lenses wi h la ge a eas
o dis ance ision send a g ea e pe cen age o ligh o
he dis ance ocus, he eby educing he amoun o ou -
o - ocus ligh , which ansla es in o less ligh dis u bance
and inc eased con as modula ion. Howe e , he shape o
he ligh dis u bance could emain unal e ed because bo h
lenses ha e ci cula ings o he same shape.
Al hough no di ec ly compa able, he CL wi h he me-
dium inne zone diame e showed simila ligh dis u bance
o a myopia con ol DF CL assessed in a p e ious s udy.16
Ne e heless, he design wi h he smalle inne zone diam-
e e showed g ea e ligh dis u bance compa ed wi h he
esul s ound in he p e ious in es iga ion.
Wa e on abe a ions
P e ious s udies1,5,16,54,55 ound ha DF and mul i ocal CLs
induce highe le els o HOA due o he concen ic zones
o inc easing powe . The medium inne zone diame e lens
showed highe le els o HOA o a 5 mm pupil diame e .
This does no co ela e wi h ou ligh dis u bance indings,
whe e subjec s i ed wi h he M design epo ed less ligh
dis u bance compa ed wi h he S design.
This migh be explained as he M lens has a mo e p o-
g essi e powe design han he S lens. In opposi ion o
hese indings, Ma ins e al.1 ound lowe HOA in lenses
wi h la ge a eas o dis ance ision. Mo eo e , i has also
been epo ed ha he image quali y o CLs wi h la ge cen-
al diame e s is less a ec ed by sphe ical abe a ion.8 HOA
in he p esen s udy we e simila o hose ound in a p e i-
ous in es iga ion using a di e en myopia con ol CL.16 I is
wo h no ing ha due o he ab up changes in he powe
p o iles o bo h designs, hese wa e on s migh no be
bes ep esen ed by a Ze nike expansion.48
Tea ilm s abili y
Tea ilm s abili y did no show signi ican di e ences be-
ween he CLs, sugges ing ha changes in he diame e o
he zones did no a ec p e- lens ea ilm sp eading and
s abili y ac oss he CL su ace. To ou knowledge, only one
p e ious s udy measu ed p e- lens ea ilm s abili y wi h a
DF CL.28 They ound dec eased ea ilm s abili y wi h a DF
CL compa ed wi h a single- ision CL made om he same
ma e ial. This migh be caused by he dec eased sp eading
o he p e- lens ea ilm ac oss he concen ic ing pa e n.
In compa ison wi h his p e ious wo k, ea ilm s abili y
was simila o o sligh ly be e wi h he CLs assessed in he
cu en in es iga ion.
The p esen s udy assessed ea ilm s abili y 25 minu es
a e lens inse ion. Howe e , ea ilm s abili y and com-
o migh change ollowing longe pe iods o CL wea .
Ne e heless, o he in es iga ions epo ed ha his pe-
iod is adequa e o e alua e he sho - e m pe o mance
o CLs.56– 59 The ea ilm changes du ing he i s 20 min
TABLE 6 Quali y o Vision ques ionnai e sco es o each con ac lens
Measu emen Lens
Median
(In e qua ile
ange)
Signi icance le el
(S a is ic, p- alue)
QoV equency
sco e
S49 (42– 59) (Z27=−0.99, p=0.32)a
M49 (37– 52)
QoV se e i y sco e S 42 (35– 48.5) (Z27=−1.16, p=0.25)b
M39 (32– 47)
QoV bo he some
sco e
S42 (29– 53) ( 27= 0.38, p=0.70)a
M38 (29– 49)
No e: S=con ac lens wi h an inne zone diame e o 2.1 mm; M=con ac lens
wi h an inne zone diame e o 4.0 mm; QoV=Quali y o Vision.
aWilcoxon.
bT- es .
TABLE 7 Visual analogue scale o sho - e m lens com o o each
con ac lens
Measu emen Lens
Median (In e qua ile
ange) p- Value
O e all sho - e m
lens com o sco e
S3.00 (2.00– 4.00) 0.33a
M3.50 (2.00– 5.00)
Physical sho - e m
lens com o sco e
S3.00 (2.00– 4.00) 0.89a
M3.00 (2.00– 4.00)
Visual sho - e m lens
com o sco e
S4.00 (3.00– 5.75) 0.26a
M4.00 (3.00– 4.75)
No e: S=con ac lens wi h an inne zone diame e o 2.1 mm; M=con ac lens
wi h an inne zone diame e o 4.0 mm.
aWilcoxon.