Influence of ocular biometric factors on the defocus curve in an enlarged depth-of-focus intraocular lens

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h ps://doi.o g/10.1007/s10792-022-02496-y
ORIGINAL PAPER
In luence o ocula biome ic ac o s on hede ocus cu e
inanenla ged dep h‑o ‑ ocus in aocula lens
Galad ielGiménez‑Cal o · F anciscode AsísBa ol‑Puyal·
I eneAl emi · Sil iaMéndez‑Ma ínez· C is inaAlmena a·
DianaSo iano‑Pina· AneMu ue a‑Goyena· JoséManuelLa osa
Recei ed: 29 Decembe 2021 / Accep ed: 20 Augus 2022 / Published online: 27 Sep embe 2022
© The Au ho (s) 2022
abe a ions we e measu ed. 1 mon h a e su ge y,
dis ance, in e media e, and nea isual acui ies (VA)
we e eco ded. A 3mon hs, monocula and binocu-
la co ec ed con as sensi i i ies unde pho opic
and mesopic ligh ing condi ions we e measu ed wi h
CSV-1000E es . A 6-mon hs, he de ocus cu e
be ween −5.00 o + 3.00 diop e s (D) was assessed in
s eps o 0.50 D, and NEI-RQL-42 ques ionnai e was
adminis e ed.
Resul s One hund ed hi y one eyes o 66 pa ien s
we e included. Binocula logMAR VA be e han
0.1 o in e media e ision was ob ained in 90% o
pa ien s, whe eas only 17.7% ob ained ha esul in
nea ision. The a e o sa is ac ion was high (96%)
and mos o hem (85.5%) had no o li le di icul ies
in nea ision. The mean ampli ude o he de ocus
cu e was 2.35D ± 0.73D, and smalle AL, smalle
pupils, younge age, and male sex we e associa ed
wi h wide ange o clea ision.
Conclusions Tecnis Sym ony IOL enables unc-
ional ision a all dis ances, bu demog aphic a i-
ables and p eope a i e biome ic measu emen s like
AL and pupil size in luence he pos ope a i e ampli-
ude o he de ocus cu e. These pa ame e s could be
used o p edic he pe o mance o EDoF IOLs.
Keywo ds Mul i ocal IOLs· EDoF IOLs·
Di ac i e· Ca a ac · Quali y o ision
Abs ac
Backg ound To assess he in luence o biome ic
measu emen s on he de ocus cu e a e he implan-
a ion o enla ged dep h-o - ocus (EDoF) in aocula
lens (IOL).
Me hods Pa ien s who unde wen ca a ac su ge y
wi h bila e al implan a ion o Tecnis Sym ony IOL
we e en olled. P eope a i ely, axial leng h (AL),
co neal ke a ome y (K), pupil size and co neal
G.Giménez-Cal o· F.d.Ba ol-Puyal· I.Al emi ·
S.Méndez-Ma ínez· C.Almena a· D.So iano-Pina·
J.M.La osa
Oph halmology Depa men , Miguel Se e Uni e si y
Hospi al, Paseo Isabel la Ca ólica, 1-3, 50009Za agoza,
Spain
G.Giménez-Cal o· F.d.Ba ol-Puyal· I.Al emi ·
S.Méndez-Ma ínez· C.Almena a· D.So iano-Pina·
J.M.La osa
Miguel Se e Oph halmology Resea ch G oup (GIMSO),
A agón Ins i u e o Heal h Resea ch (IIS A agón),
Za agoza, Spain
G.Giménez-Cal o(*)· F.d.Ba ol-Puyal· I.Al emi ·
J.M.La osa
Uni e si y o Za agoza, Za agoza, Spain
e-mail: ggimenez@uniza .es
A.Mu ue a-Goyena
Neu odegene a i e Diseases G oup, Bioc uces Bizkaia
Heal h Resea ch Ins i u e, Ba akaldo, Bizkaia, Spain
A.Mu ue a-Goyena
Depa men o Neu osciences, Uni e si y o  heBasque
Coun y (UPV/EHU), Leioa, Bizkaia, Spain
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Value s a emen
Wha was known
• Clinical e icacy and sa e y o ex ended dep h o
ocus (EDoF) IOLs a e ca a ac su ge y has been
p o en.
• Visual capabili ies in nea ision a e usually lim-
i ed o 1m in pa ien s implan ed wi h EDoF IOLs,
al hough ou comes a y om pa ien o pa ien ,
some subjec s achie ing excellen isual acui ies
(≤ 0.1 LogMAR) in nea ision.
• Ocula biome ic pa ame e s a e known o in lu-
ence on he ange o clea ision wi h mul i ocal
IOL, bu o ou knowledge, no p io s udy has
e alua ed his ela ionship in EDoF IOLs.
Wha his pape adds
• Bila e al implan a ion o EDoF IOLs p o ides sa -
is ac o y isual esul s in highly selec ed pa ien s.
• Demog aphic and p eope a i e biome ic meas-
u emen a e associa ed wi h he ampli ude o he
de ocus cu e, e en a e con olling o he e ec
o age and sex.
In oduc ion
Al hough monocula in aocula lenses (IOLs) ha e
imp o ed he isual quali y o pa ien s unde going
ca a ac su ge y, he independence o co ec ion o
in e media e and nea ision is inc easing. In he las
decade, se e al ypes o mul i ocal IOLs ha e been
designed o imp o e spec acle independence a e
ca a ac su ge y. Unlike he p eceding mono ocal
IOLs, mul i ocal IOLs p o ide good isual ou comes
a di e en dis ances [1]. Mo eo e , new gene a ion
mul i ocal IOLs ha e been designed o o e come
some disad an ages o p e ious mul i ocal IOLs
a ibu able o hei inhe en op ical design, such as
hepe cep ion o pho ic phenomena, educed con as
sensi i i y (CS), and dec eased isual unc ion in dim
ligh en i onmen s [2, 3].Fo a success ul ou come
and mee pa ien s’ expec a ion, i is c ucial o con-
side p eope a i e ac o s, including biome ic meas-
u emen s, pupil eac i i y o pa ien ’s li es yle [1].
Tecnis® Sym ony® ZXR00 (Abbo Labo a o ies,
Illinois, USA) p oduces an ex ended dep h o ocus
in o de o imp o e isual ou comes a in e media e
dis ances. P e ious s udies ha e e ealed ha Tecnis
Sym ony IOLs exhibi good isual ou comes a e
su ge y [4, 5]. In pa icula , hey p o ide be e objec-
i e and subjec i e quali y o ision and CS compa ed
o i ocal lenses and p oduce less pho opic phenom-
ena [5–7]. Ne e heless, hei pe o mance is wo se
a nea ision, and accep able in e media e ision
a ies la gely among pa ien s. The e o e, he aim o
his s udy was o analyze demog aphic and p eope a-
i e ac o s ela ed o enla ged pos ope a i e dep h-
o - ocus in pa ien s implan ed wi h Tecnis Sym ony
ZXR00.
Me hods
S udy design and pa icipan s
This p ospec i e s udy included 131 eyes o
66 pa ien s wi h bila e al ca a ac s ha unde wen
phacoemulsi ica ion ca a ac su ge y and Tecnis Sym-
ony IOL implan a ion. Pa ien s we e ec ui ed a he
oph halmology depa men o Nues a Seño a de G a-
cia Hospi al in Za agoza, and p ospec i ely e alua ed
a 1-mon h, 3-mon hs, and 6-mon hs. Pa ien s we e
selec ed acco ding o he guidelines o he gene al
p o ocol o ca a ac su ge y dic a ed o ou hospi al.
Inclusion c i e ia we e no al e a ions o p e iousoph-
halmological su ge ies, no d y eye, opog aphic
as igma isms lowe han 1.00 D ( o al as igma ism,
including pos e io su ace), pos ope a i e co ec ed
isual acui y (CDVA) be e han 0.2 logMAR, no
in a- o pos ope a i e complica ions, absence o pos-
e io capsule opaci ica ion (PCO) du ing he s udy,
and a cen e shi alue (dis ance be ween co neal
apex and cen e o pupil) lowe han 1mm.The s udy
p o ocol was app o ed by he local e hics commi ee
CEICA (Comi é de É ica de la In es igación de la
ComunidadAu ónoma de A agón) and pa ien s ga e
w i en in o med consen ollowing he ene s o Dec-
la a ion o Helsinki.
In aocula lens
Tecnis® Sym ony® ZXR00 lens is a single-piece,
bicon ex, hyd ophobic ac ylic olding lens, wi h a
pos e io di ac i e su ace and an an e io asphe i-
cal su ace ha adds a −0.27μm sphe ical abe a ion
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o compensa e he posi i e co neal sphe ical abe a-
ion. I also uses a p op ie a y ach oma ic di ac i e
Echele e design ha co ec s he co neal ch oma ic
abe a ion o enhanced CS [4]. I s o e all diame e
is 13.0mm, and i s op ical zone diame e is 6.0mm.
The powe spec um a ailable anges om + 5.0 o
+ 34.0 D and inco po a es an ul a iole (UV) ligh -
abso bing il e .
Su gical p ocedu e
Su ge y was pe o med unde opical anes hesia by
he same expe ienced su geon (J.M.L.) and using
he same s anda d phacoemulsi ica ion echnique.
A 2.7 mm clea incision was made a empo al
si e (180º-0º) using a blade. The capsulo omy size
in ended by he su geon was 5.5mm and he esul -
ing size o capsulo omy nex day o he su ge y was
app oxima ely 5.25 mm. SRK-T, Kane and Ba -
e Uni e sal II o mulas we e used o calcula e he
powe o he IOL. The a ge e ac i e ou come was
emme opia. The selec ed IOL cons an was 119.36.
The second eye was in e ened 1mon h a e he i s
one.
S udy e alua ions
All pa ien s unde wen a comple e p eope a i e
examina ion ha included: explo a ion o he an e-
io segmen wi h sli lamp, Goldmann applana ion
onome y and pos e io pole undoscopy a e pha -
macological myd iasis. Op ical biome y was pe -
o med using IOLMas e 500 (Ca l Zeiss Medi ec
AG, Jena, Ge many). AL, an e io chambe dep h
(ACD), mean ke a ome y, as igma ism (A) and
sphe ical equi alen (SE) we e ob ained.Co neal ke -
a ome y (K) and abe a ions we e measu ed using
he Pen acam Scheimp lug came a (OculusWe zla ,
Ge many). In addi ion, pupilla y size and co neal
abe a ions we e measu ed using he KR-1W wa e-
on analyze (Topcon Medical Lase Sys ems, Inc.,
CA, USA) p eope a i ely and one mon h a e  he
implan a ion o bo h IOLs.
One-mon h a e he su ge y o he second eye,
monocula and binocula CDVA and unco ec ed dis-
ance isual acui ies (UDVA) we e measu ed unde
pho opic ligh condi ions (85 cd/m2), using Ea ly
T ea men Diabe ic Re inopa hy S udy (ETDRS)
cha s (ESV-3000 ETDRS Sys em, Vec o ision,
Inc.) a 4m. The p ocedu e was epea ed o ob ain-
ing VA a in e media e (63 cm) and nea (40 cm)
dis ances wi h bes dis ance co ec ion. Dis ance VA
unde en i onmen al mesopic ligh condi ions (6cd/
m2), and using a il e on op o he ETDRS cha ,
was also measu ed in his isi .
A 3- mon hs, monocula and binocula dis ance
co ec ed CS unde pho opic (85cd/m2) and mesopic
(6cd/m2) ligh condi ions we e measu ed a 2.5m
wi h CSV-1000E es using sine wa e g a ings wi h
di e en spa ial equencies: 3cpd (cycles pe deg ee
o isual angle), 6cpd, 12cpd and 18cpd. Pa ien s
ha did no see he i s s imuli we e assigned a 0
alue.
Six mon hs a e he su ge y, he de ocus cu e
was calcula ed using powe ed lenses om −5.00
o + 3.00 D, in in e als o 0.50 D. ETDRS cha s
we e andomly changed 3 imes du ing hese p oce-
du es o a oid memo iza ion. The i s one was used
o measu e DCVA wi h 0 de ocus. Then, he cha
was changed o measu e VA using lenses om −5 o
−0.50 D, in s eps o 0.50D. A hi d ETDRS cha was
used o measu ing VA om + 3D o + 0.50D. The
ange o clea ision (RCV) was ob ained monocu-
la ly as he magni ude o diop e s wi hin he de o-
cus cu e in which he bes co ec ed isual acu-
i y (BCVA) was equal o g ea e han 0.1 logMAR.
Pa ien s answe ed he NEI-RQL-42 ques ionnai e,
which measu es ision on daily ac i i ies (i ems 2 o
22), pe cei ed pa ien ’s ision (i ems 13 o 22), op i-
cal co ec ions (i ems 23 o 35), and ela ed possible
p oblems (36 o 42). The NEI-RQL-42 sco e anges
om 0 o 100, 100 ep esen ing he bes quali y o
li e pe cei ed by he pa ien . Usually, 13 subi ems a e
calcula ed based on he ollowing ca ego ies: cla i y
o ision, expec a ions, nea ision, a ision, diu -
nal luc ua ions, ac i i y limi a ions, gla e, symp oms,
dependence on co ec ion, wo y, subop imal co ec-
ion, sa is ac ion wi h co ec ion.
S a is ical analysis
S a is ical analysis was done in R ( e sion3.6.1) and
RS udio ( e sion 1.2.1335). Da a dis ibu ion was
checked o no mali y using he Shapi o-Wilks es .
Analyses we e conduc ed using gene alized es ima -
ing equa ion (GEE) models wi h an exchangeable
wo king co ela ion s uc u e o accoun o co ela-
ion be ween he wo eyes om a single pa icipan
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and using geepack package o pe o m all GEE analy-
ses. p- alues lowe han 0.05 we e conside ed o be
s a is ically signi ican .
Resul s
We included 131 eyes om 66 subjec s implan ed
wi h Tecnis® Sym ony® ZXR00 IOL. One eye was
excluded because o epi e inal memb ane. Demo-
g aphic and p eope a i e biome ic measu emen s
a e ep esen ed in Table 1. B ie ly, 31 emales
and 35 males we e included aged be ween 40 and
Table 1 Demog aphic
and p eope a i e biome ic
measu emen s
K ke a ome y, HOA high
o de abe a ions, RMS
oo mean squa e, WFA
wa e on abe a ion, Z40
sphe ical abe a ion (6-mm
zone)
Mean (SD) Range (min–max)
Demog aphics
Age (yea s old) 64.64 (6.67) 40–76
Gende , n( % emale) 31 (47%)
P eope a i e biome ic measu emen s
Re ac ion
CDVA (logMAR) 0.28 (0.21) −0.12–1.00
Sphe ical equi alen −0.03 (0.22) −0.92–0.71
IOLMas e
Axial leng h 23.52 (0.85) 21.61–25.50
An e io chambe dep h 3.25 (0.38) 2.40–4.14
Pen acam
Mean K43.73 (1.30) 40.80–46.50
WFA Z40 (6-mm) 0.39 (0.12) 0.07–0.80
WFA RMS (4-mm) 0.19 (0.08) 0.07–0.47
KR-1W o 4-mm pupil size
To al HOA 0.15 (0.06) 0.06–0.53
Sphe ical 0.05 (0.02) −0.01–0.11
As igma ism −0.68 (0.42) −2.33–−0.03
Thi d 0.13 (0.05) 0.02–0.45
Fo h 0.08 (0.03) 0.02–0.29
T e oil 0.09 (0.06) 0.01–0.44
Coma 0.08 (0.04) 0.01–0.19
Te a oil 0.03 (0.03) 0.00–0.29
2nd As igma ism 0.03 (0.02) 0.00–0.08
KR-1W o 6-mm pupil size
To al HOA 0.48 (0.27) 0.26–2.31
Sphe ical 0.27 (0.19) −0.15–1.73
As igma ism −0.53 (0.53) −4.53–−0.03
Thi d 0.36 (0.51) 0.07–4.74
Fo h 0.36 (0.44) 0.07–4.21
T e oil 0.24 (0.41) 0.03–3.81
Coma 0.24 (0.31) 0.02–2.83
Te a oil 0.13 (0.33) 0.00–3.02
2nd As igma ism 0.11 (0.26) 0.00–2.37
KR-1W pupil size
Sco opic 5.22 (0.94) 2.74–7.41
Pho opic 3.44 (0.79) 1.69–5.81
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76 yea s (mean age, 64.6 ± 6.7 yea s old). Mean
AL was 23.52 ± 0.85mm, and mean implan ed IOL
powe was 21.48 ± 2.36 D.
Pos ope a i e isual acui y and quali y o li e
Table2 and Fig.1 show he 1-mon h pos ope a i e
measu emen s. The mean sphe ical equi alen a e
su ge y was −0.09 ± 0.27 D and UCDVA and CDVA
we e −0.01 ± 0.07 and −0.02 ± 0.06 logMAR, espec-
i ely. The unco ec ed isual acui ies a in e medi-
a e (63cm) and nea (40cm)dis ances 1-mon h a e
su ge y we e 0.07 ± 0.11 and 0.27 ± 0.12, espec-
i ely, and VAs sligh ly imp o ed wi h co ec ion
(Fig.1A). O e all, mesopic dis ance VAs we e lowe
han pho opic dis ance VAs, bu we e subjec o mo e
imp o emen a e e ac i e co ec ion (Table 2).
The cumula i e VAs in Fig. 1A show ha , o e all,
he unco ec ed VAs we e be e a in e media e and
nea ision bu wo se a dis ance, as all pa ien s wi h
pos ope a i e e ac i e e o s—no eaching emme-
opia—had myopia o myopic as igma ism (10.6%).
Table3 shows CS a di e en spa ial equencies
3mon hs a e su ge y. Al oge he , binocula CS was
be e han monocula CS in all spa ial equencies.
Simila ly, pho opic CS was sligh ly highe han mes-
opic CS (Fig.1B, C). The highes CS was ob ained
wi h 6cpd g a ings wi h a con inuous dec ease in CS
wi h inc easing cycles pe deg ee. All measu emen s
o CS we e conside ed o be wi hin no mal anges.
Impac o e ac i e e o on quali y o li e
Table4 shows he subjec i e quali y o ision ela ed
o e ac i e e o epo ed by 53 ou o 66 pa ien s
6 mon hs pos ope a i ely. The sa is ac ion subi em
o he ques ionnai es showed ha 96% o pa ien s
we e e y o comple ely sa is ied wi h he esul s.
A 6mon hs, 85.5% o pa ien s had li le o no di -
icul ies in nea ision, and 98% o pa ien s e e ed
op imal ision. Indeed, 90.5% o pa ien s had com-
ple e independence o e ac i e co ec ion, and 34%
epo ed o ha e no o li le di icul y d i ing. S ill, a
small pe cen age o pa ien s epo ed gla e (7.7%) o
halos (13.2%) mos o all he ime.
Range o clea ision a 6-mon hs
Six mon hs a e he in e en ion o he second eye,
he ange o clea ision was calcula ed. Monocu-
la de ocus cu e (Fig. 2) showed ha CDVA was
ob ained wi h −0.18D ± 0.40 de ocus lens on a e age,
co esponding o dis ance ision. The de ocus lenses
o bes VA anged be ween + 0.5D and −1.50D.
Table 2 One-mon h
pos ope a i e e ac i e and
isual ou comes
CDVA co ec ed dis ance
isual acui y, DCIVA
dis ance co ec ed
in e media e dis ance isual
acui y, DCNVA dis ance
co ec ed nea isual acui y,
SE sphe ical equi alen ,
UDVA unco ec ed dis ance
isual acui y, UIVA
unco ec ed in e media e
dis ance isual acui y,
UNVA unco ec ed nea
isual acui y, VA isual
acui y
Monocula Binocula
Mean (SD) Range (min–max) Mean (SD) Range (min–max)
SE (D) −0.09 (0.27) −1.5–0
Pho opic VA (logMAR)
UDVA −0.01 (0.07) −0.2–0.3 −0.06 (0.07) −0.40–0.10
UIVA 0.07 (0.11) −0.2–0.44 0.01 (0.08) −0.16–0.28
UNVA 0.27 (0.12) 0.06–0.58 0.19 (0.10) −0.06–0.46
CDVA −0.02 (0.06) −0.2–0.14 −0.07 (0.07) −0.40–0.08
DCIVA 0.08 (0.13) −0.2–0.76 0.00 (0.09) −0.20–0.24
DCNVA 0.28 (0.12) 0.06–0.58 0.20 (0.10) −0.06–0.46
Mesopic VA (logMAR)
UDVA 0.25 (0.10) 0.10–0.64 0.18 (0.08) 0.00–0.36
CDVA 0.24 (0.09) 0.10–0.48 0.17 (0.08) 0.00–0.36
Pho opic VA wi h gla e (logMAR)
UDVA 0.00 (0.08) −0.18–0.36 −0.06 (0.06) −0.18–0.10
CDVA −0.01 (0.07) −0.18–0.18 −0.07 (0.06) −0.18–0.08
Mesopic VA wi h gla e (logMAR)
UDVA 0.25 (0.11) −0.04–0.52 0.16 (0.10) −0.06–0.40
CDVA 0.24 (0.11) −0.04–0.50 0.16 (0.10) −0.06–0.40

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Fig. 1 Pos ope a i e isual ou comes a e bila e al Tecnis
Sym ony implan a ion. A Cumula i e monocula isual acui-
ies a di e en dis ances. Pe cen age o pa ien s ha achie ed
he dis ance-co ec ed logMAR VA a 4m (dis ance), 63cm
(in e media e) and 40cm (nea ) a 1mon h a e he implan a-
ion o Sym ony IOL. B Unco ec ed mean monocula and bin-
ocula isual acui ies a e 1-mon h pos ope a i ely. Monocu-
la and binocula co ec ed con as sensi i i y a 3mon hs in
pho opic (B) and mesopic (C) ligh condi ions. CS, con as
sensi i i y; VA, isual acui y
Table 3 Con as
sensi i i y esul s wi h
CSV1000e es a 3mon hs
cpd cycles pe deg ee
Monocula Binocula
Mean (SD) Range (min–max) Mean (SD) Range (min–max)
Pho opic
3cpd 1.58 (0.20) 1.17–2.08 1.71 (0.17) 1.34–2.08
6cpd 1.78 (0.22) 1.38–2.29 1.86 (0.23) 0.70–2.29
12cpd 1.37 (0.25) 0.61–1.99 1.51 (0.25) 0.40–1.84
18cpd 0.96 (0.29) 0.13–1.64 1.09 (0.21) 0.64–1.55
Mesopic
3cpd 1.43 (0.22) 0.70–2.08 1.55 (0.24) 0.81–2.08
6cpd 1.46 (0.24) 0.91–1.99 1.57 (0.24) 0.91–2.14
12cpd 0.88 (0.29) 0.00–1.69 0.99 (0.31) 0.61–1.99
18cpd 0.47 (0.33) 0.00–1.25 0.58 (0.28) 0.17–1.25
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O e all, 90% o he pa ien s ob ained an unco ec ed
binocula logMAR isual acui y be e han 0.1 o
in e media e ision (-1.5D de ocus lens), whe eas
in nea ision, only 17.7% o pa ien s ob ained ha
esul . Howe e , 61.2% o pa ien s p esen ed an
unco ec ed binocula VA o 0.2 logMAR o highe
in nea ision. The mean ange o clea ision was
2.35D ± 0.73D, bu i a ied conside ably among
pa ien s, anging om 0D o 4.5D.
P eope a i e biome ic measu emen s associa ed wi h
ange o clea ision
To iden i y signi ican p eope a i e p edic o s o he
RCV a 6mon hs, we i ed Gene alized Es ima ing
Equa ions o con ol om in e -eye in asubjec co -
ela ions (Table5). We ound ha age was nega i ely
associa ed wi h he RCV (p = 0.002). The es ima ed
dec ease in RCV was −0.05D o e e y one-uni
inc ease in age. Male sex was signi ican ly associ-
a ed wi h b oade RCV (β: 0.61, p = 0.047). Among
he ocula biome ic pa ame e s, we ound ha axial
leng h and pupil size we e signi ican ly associa ed
wi h RCV a 6mon hs, a e con olling o he e ec
o age and sex. The la ge he axial leng h o he
pupil size, he na owe he RCV. Fo axial leng h,
1-mm inc ease esul ed in 0.35D dec ease in RCV
(p = 0.023). Rega ding pupil size, RCV dec eased
app oxima ely 0.40D pe 1 uni inc ease in pupil
diame e (pho opic pupil size, β = −0.41, p = 0.009;
sco opic pupil size, β = −0.397, p = 0.002), a e con-
olling o he e ec o age and sex. We ailed o
ind signi ican associa ions o p eope a i e an e io
chambe dep h, sphe ical and high-o de ocula abe -
a ions o 4-mm pupil size o mean ke a ome y wi h
pos ope a i e RCV. None heless, we ound a signi i-
can nega i e associa ion o sphe ical abe a ion, hi d
and ou h o de abe a ions, and 2nd as igma ism o
6-mm pupil size wi h RCV in adjus ed models.
Table 4 NEI-RQL-42 ques ionnai e esul s by ca ego y
Mean (SD) Range (min–max)
Cla i y o ision 89.87 (13.78) 39.6–100
Expec a ion 60.24 (33.20) 0–100
Nea ision 84.84 (12.48) 56.25–100
Fa ision 80.02 (20.17) 35–100
Diu nal luc ua ions 81.78 (16.32) 45.8–100
Ac i i y limi a ion 95.00 (12.39) 31.3–100
Gla e 69.29 (25.24) 0–100
Symp oms 79.79 (16.28) 35.7–100
Dependence on co ec ion 64.05 (29.86) 0–100
Wo y 61.43 (28.70) 0–100
Subop imal co ec ion 97.14 (7.99) 62.5–100
Appea ance 92.76 (12.12) 60–100
Sa is ac ion 91.81 (11.33) 60–100
Fig. 2 Mean monocula dis ance-co ec ed de ocus cu es a
6mon hs a e bila e al Tecnis Sym ony EDoF IOL implan a-
ion. Pa ien s we e classi ied in o 3 uni o m g oups acco ding
o hei pupil size in pho opic and sco opic ligh condi ions.
De ocus cu es a e ep esen ed o each pa ien subg oup
o show how he VA depends on pupil size. The limi s o
pupilla y diame e o each subse we e as ollows: in pho-
opic ligh  condi ions, small [1.69mm–3.14mm), medium
[3.14mm–3.73mm), and la ge [3.73mm–5.82mm); in sco opic
ligh condi ions, small [2.73mm–4.97mm), medium [4.97mm–
5.73mm), and la ge [5.73mm–7.42mm).VA, isual acui y
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Discussion
In his s udy, we in es iga ed demog aphic and p e-
ope a i e biome ic measu emen s associa ed wi h
6-mon hs pos ope a i e ange o clea ision o eyes
implan ed wi h Tecnis® Sym ony® ZXR00 IOL a e
phacoemulsi ica ion. Ou esul s indica e ha young
age, male sex, and smalle axial leng h and pupilsize
we e associa ed wi h wide ange o clea ision a
6-mon hs. These esul s indica e ha e en in highly
selec ed pa ien s o IOL implan a ion (less han 1D
co neal as igma ism, low ocula abe a ions, no ocu-
la pa hology), he e a e demog aphic and biome ic
ac o s ha could p edic pos ope a i e ange o clea
ision.
Tecnis® Sym ony® ZXR00 is an EDoF IOL ha
p esen s a wide ange o sha p ision wi h minimal
associa ed pho ic phenomena. The esul s o his
s udy e eal ha pos ope a i e UDVA and CDVA
we e a o able, achie ing p ope in e media e VAs
and enla ged ampli ude o pseudo-accommoda ion.
In addi ion, subjec i e op imal co ec ion and pos -
ope a i e pa ien sa is ac ion we e high. The s udies
published o e he las wo yea s a e in line wi h he
cu en indings, highligh ing good isual ou comes
a e Tecnis Sym ony implan a ion [8–12]. Howe e ,
Table 5 Gene al es ima ing
equa ion models o he
associa ion o p eope a i e
a iables wi h pos ope a i e
ange o clea ision
Signi ican p- alues a e
highligh ed in bol
GEE gene al es ima ing
equa ions, SE s anda d
e o , HOA high o de
abe a ions, K ke a ome y,
RMS oo mean squa e,
WFA wa e on abe a ion,
Z40 sphe ical abe a ion
(6-mm zone)
GEE Age and gende adjus ed
GEE
Es ima e SE p alue Es ima e SE p alue
Age −0.053 0.017 0.002
Gende (male) 0.614 0.309 0.047
IOLMas e
Axial leng h (mm) −0.232 0.172 0.177 −0.350 0.154 0.023
An e io Chambe Dep h (mm) 0.037 0.397 0.925 −0.429 0.337 0.203
KR-1W
Pho opic pupil size (mm) −0.525 0.169 0.002 −0.406 0.156 0.009
Sco opic pupil size (mm) −0.428 0.155 0.006 −0.397 0.127 0.002
4-mm pupil size
To al HOA 0.853 1.741 0.620 0.433 1.220 0.796
Sphe ical abe a ion −5.01 5.78 0.39 −3.562 5.523 0.519
3 d-o de 1.874 2.061 0.36 1.074 1.974 0.587
4 h-o de −2.671 3.692 0.47 −2.162 3.323 0.513
T e oil 2.81 2.38 0.24 1.280 2.216 0.564
Coma −1.863 3.317 0.57 0.142 3.259 0.965
Te a oil −0.865 2.819 0.76 0.068 2.376 0.977
2nd as igma ism −2.75 6.877 0.69 −4.018 6.481 0.535
6-mm pupil size
To al HOA (6-mm pupil) −0.269 0.421 0.520 −0.338 0.401 0.399
Sphe ical abe a ion (6-mm pupil) −0.859 0.454 0.059 −0.900 0.421 0.034
3 d-o de −0.162 0.088 0.068 −0.183 0.093 0.049
4 h-o de −0.243 0.118 0.040 −0.285 0.127 0.025
T e oil −0.174 0.146 0.230 −0.226 0.141 0.107
Coma −0.188 0.204 0.360 −0.177 0.221 0.425
Te a oil −0.253 0.146 0.083 −0.294 0.151 0.052
2nd as igma ism −0.416 0.242 0.085 −0.503 0.256 0.049
Pen acam
Mean K0.239 0.131 0.068 0.197 0.120 0.101
WFA Z40 −1.038 1.244 0.400 −0.597 1.252 0.634
WFA RMS 1.272 1.732 0.460 1.694 1.702 0.320
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mos au ho s ag ee ha nea ision migh be limi ed
in some pa ien s. E en wi h dis ance co ec ed e ac-
ion, i has been obse ed ha some pa ien s achie e
good isual acui ies (≤ 0.1 LogMAR o 0.8 decimal)
as nea as 20cm, whe eas o he s only each a sha p
ision un il one me e . Some au ho s ha e sugges ed
ha a ge ing a mild myopia in non-dominan eye
imp o es pos ope a i e ou comes [10]. The a iabil-
i y in he ange o clea ision wi h mul i ocal IOL
has been a ibu ed o se e al ac o s, bu he in lu-
ence on ex ended ocus IOLs has no been ex ensi ely
explo ed. In he cu en s udy, we ound ha younge
age was associa ed wi h wide ange o clea ision,
which is in line wi h s udies e alua ing appa en
accommoda ion in eyes wi h a mono ocal IOLs [13].
Mo eo e , we also ound ha male gende was associ-
a ed wi h wide ange o clea ision in he de ocus
cu e measu ed a 6mon hs. Howe e , i should be
no ed ha he younges pa ien s we e all male, and
his ac migh ha e con ounded he cu en esul s.
On he o he hand, sphe ical abe a ion is known o
inc ease he dep h o ocus, al hough i de e io a es
CS [14]. Fu he mo e, o he p eope a i e high o de
abe a ions ha e also been associa ed wi h di e -
en pos ope a i e ision measu emen s, mainly in
nea ision [15]. Howe e , we only ound signi ican
associa ions be ween p eope a i e sphe ical and high
o de abe a ions and pos ope a i e de ocus cu e
wi h 6-mm pupil size, and no wi h 4-mm, which is
he e ec i e pupil size in mesopic condi ions. This
could be because pa ien s we e highly selec ed o
he p esen s udy and p onounced p eope a i e abe -
a ions we e conside ed an exclusion c i e ion, na -
owing he a iabili y o abe a ions o smalle pupil
sizes.
Las ly, p eope a i e pho opic pupil size is c i ical
o mul i ocal IOL implan a ion [16], being la ge
pupil sizes co ela ed wi h be e dis ance isual acu-
i y and wi h wo se nea isual acui y [17, 18]. S ill,
he ela ionship wi h p eope a i e pupil size and
he pos ope a i e ange o clea ision has no been
explo ed in EDoF IOLs. Acco ding o ou esul s,
p eope a i e pupil size was nega i ely associa ed wi h
he ange o clea ision, sugges ing ha pa ien s wi h
la ge pupil sizes p esen ed educed de ocus cu es.
Las ly, ocula biome ic measu emen s change as a
unc ion o age and gende [19–23] and bo h ac o s
we e signi ican ly associa ed wi h he ou come o
in e es . The e o e, all GEE models we e adjus ed o
age and sex. These analyses e ealed ha axial leng h
was also nega i ely associa ed wi h he ange o clea
ision. P e ious s udies ha e epo ed ha bo h sho
axial leng h and small pupil size p edic good nea
ision a e mono ocal IOL implan a ion [23], bu
hei ela ionship was no  explo ed in EDoF IOLs
un il now.
This s udy has se e al limi a ions. Fi s , he p i-
ma y endpoin was he monocula de ocus cu e
measu ed 6mon hs a e implan a ion, and no u -
he isual a iables we e conside ed, like nea and
in e media e ision VA o CS o pa ien sa is ac-
ion. Howe e , we belie e ha he de ocus cu e
is a ai h ul ep esen a ion o he dynamic ange o
clea ision in a single a iable. Second, IOL cen-
a ion was no assessed a e IOL implan a ion,
which migh ha e con ounded he isual ou comes
and he cu en esul s. Ne e heless, he EDoF
IOLs a e mo e obus agains op ical quali y deg a-
da ion caused by IOL decen a ion [24]. Also, he
lack o a con ol g oup is a majo limi a ion o he
cu en his s udy, and u u e wo ks ocusing on he
pe o mance o EDoF IOLs in compa ison wi h
mono ocal and mul i ocal IOLs a e needed. Finally,
i is impo an o highligh ha we excluded pa ien s
wi h poo e isual pe o mance, like pa ien s wi h
capsula opaci ica ion, isual acui y abo e 0.2 log-
MAR… so i should be aken in o accoun ha ou
esul s do no de e mine he eal clinical pe o -
mance o EDoF lenses. On he o he hand, his wo k
has se e al s eng hs. The use o GEE o e comes
some o he s a is ical sho coming o p e ious s ud-
ies, in which he in asubjec in e -eye co ela ion
was con olled by including one eye pe pa ien s o
no con olling a all o his e ec . Mo eo e , as
a as we know, his is he i s s udy e ealing he
associa ion be ween p eope a i e demog aphic and
biome ic measu emen s and pos ope a i e ange
o clea ision a e an EDoF IOL implan a ion and
se s he g ound o u u e s udies in he ield.
In conclusion, he p esen s udy demons a ed ha
age, sex, p eope a i e pupil size, and p eope a i e
axial leng h we e associa ed wi h an enla ged ange o
clea ision in eyes implan ed wi h Tecnis Sym ony
ZXR00 IOL. The pe o mance o Tecnis Sym ony is
expec ed o be maximized by smalle pupil sizes and
axial leng hs, and in young pa ien s. Rega dless o
hese a iables, Tecnis Sym ony p o ides excellen
isual esul s a dis ance and a in e media e dis ances