Ci a ion: Macías-Mu elaga, B.;
Ga ay-A ambu u, G.;
Be gado-Mijangos, R.; Coello-Ojeda,
D.; Ozae a, I.; Ga cia-Gómez, P.J.;
Ga ido-Fie o, J.; Rod íguez-Vallejo,
M.; Fe nández, J. P edic ion E o
S abiliza ion and Long-Te m
S anda d Resul s wi h a Mono ocal
In aocula Lens. Vision 2022,6, 5.
h ps://doi.o g/10.3390/
ision6010005
Academic Edi o : Da id P. Pine o
Recei ed: 23 No embe 2021
Accep ed: 10 Janua y 2022
Published: 13 Janua y 2022
Publishe ’s No e: MDPI s ays neu al
wi h ega d o ju isdic ional claims in
published maps and ins i u ional a il-
ia ions.
Copy igh : © 2022 by he au ho s.
Licensee MDPI, Basel, Swi ze land.
This a icle is an open access a icle
dis ibu ed unde he e ms and
condi ions o he C ea i e Commons
A ibu ion (CC BY) license (h ps://
c ea i ecommons.o g/licenses/by/
4.0/).
ision
A icle
P edic ion E o S abiliza ion and Long-Te m S anda d Resul s
wi h a Mono ocal In aocula Lens
Bea íz Macías-Mu elaga 1, Gonzaga Ga ay-A ambu u 2, Robe o Be gado-Mijangos 3, Daniel Coello-Ojeda 3,
I zia Ozae a 3, Pio Jésus Ga cia-Gómez 4, Jesús Ga ido-Fie o 3, Manuel Rod íguez-Vallejo 5,* and
Joaquín Fe nández 5
1Depa men o Oph halmology, C uces Uni e si y Hospi al, 48903 Ba akaldo, Spain;
[email p o ec ed]
2Begike -Oph halmology Resea ch G oup, Depa men o Oph halmology, Bioc uces Bizkaia Heal h
Resea ch Ins i u e, OSI Bilbao Basu o, Facul ad de Medicina, Campus de Vi o ia-Gas eiz, Uni e si y o he
Basque Coun y, UPV/EHU, A enida Mon e ideo 18, 48013 Bilbao, Spain; [email p o ec ed]
3Depa men o Oph halmology, A aba Uni e si y Hospi al, 01004 Vi o ia-Gas eiz, Spain;
obe o.be [email p o ec ed] (R.B.-M.); [email p o ec ed] (D.C.-O.);
icia [email p o ec ed] (I.O.); jesusma ia.ga ido ie [email p o ec ed] (J.G.-F.)
4Depa men o Oph halmology, Qui onsalud Hospi al, 01002 Vi o ia-Gas eiz, Spain;
piojesus.ga cia@qui onsalud.es
5Q ision, Depa men o Oph halmology, VITHAS Hospi al, 04120 Alme ia, Spain;
[email p o ec ed]
*Co espondence: manuel [email p o ec ed]
Abs ac :
The aim o his s udy was o assess he s abili y and di e ences be ween objec i e (O-Rx)
and subjec i e (S-Rx) e ac ion o he assessmen o he p edic ion e o (PE). A seconda y aim was
o epo he esul s o a mono ocal in aocula lens (IOL). 100 subjec s we e included o whom S-Rx
and O-Rx we e ob ained o all isi s, and o isual pe o mance, pos e io capsula opaci ica ion
incidence and Nd:YAG a es a 12 mon hs. Ei he S-Rx and O-Rx showed a hype opic shi om 1 o 6
mon hs (p< 0.05) and s abiliza ion a e 6 mon hs. S-Rx was ela ed wi h he axial leng h ( ho =
−
0.29,
p= 0.007), ob aining a majo endency owa ds hype opia in sho eyes implan ed wi h high-powe
IOLs. O-Rx showed a myopic shi in compa ison o S-Rx (p< 0.05). This esul ed in a dec ease o
he numbe o eyes in
±
0.50 D and
±
1.00 D om 79 o 67% and om 94 o 90%, espec i ely. The
median (in e qua ile ange) unco ec ed and co ec ed isual acui ies we e 0.1 (0.29) and 0 (0.12)
logMAR, espec i ely, and se en eyes equi ed Nd:YAG capsulo omy a 12 mon hs. Some cau ion
should be aken in PE s udies in which O-Rx is used o S-Rx is measu ed in a 1-mon h ollow-up.
Cons an op imiza ion should be conduc ed o his IOL a e S-Rx s abiliza ion.
Keywo ds: in aocula lens; p edic ion e o ; s abiliza ion
1. In oduc ion
Sa is ac ion a e ca a ac su ge y wi h he implan a ion o a mono ocal in aocula
lens (IOL) esul s om a mul i ac o ial app oach [
1
–
3
], which includes achie ing he lowes
possible pos ope a i e esidual e ac ion ha allows dis ance spec acle independence [
4
].
Se e al o mulas ha e been de eloped and compa ed h ough he p edic ion e o (PE),
which is he di e ence be ween he pos ope a i e sphe ical equi alen (SE) ob ained om
he subjec i e e ac ion and he p edic ed e ac ion (PR) p o ided by he o mula o
a pa icula implan ed IOL powe [
5
]. Fo una ely, s anda ds o epo ing esul s wi h
mono ocal IOLs and o o mulae compa ison ha e been de eloped o educe he bias
among esul s epo ed by se e al au ho s [
6
–
10
]. Howe e , some s udies s ill ail in
epo ing he o mula used o selec ing he implan ed IOL powe [
11
], use objec i e
e ac ion o assessing he PE [
12
–
14
], and he e is s ill a lack o consensus on e ac ion
s abiliza ion a one mon h [
7
] o longe pe iods o ime [
6
]. The main aim o his s udy was
Vision 2022,6, 5. h ps://doi.o g/10.3390/ ision6010005 h ps://www.mdpi.com/jou nal/ ision
Vision 2022,6, 5 2 o 8
o assess how PE could be in luenced by a e ac ion p ocedu e, objec i e e sus subjec i e,
a se e al pe iods o ollow-up. A seconda y aim was o assess he s anda d esul s ob ained
a e 12 mon hs o implan a ion o a mono ocal p eloaded hyd ophobic IOL.
2. Ma e ials and Me hods
2.1. Subjec s and P ocedu es
The s udy was app o ed by he D ug Resea ch E hics Commi ee o Euskadi (PS2018031)
and was pe o med in adhe ence o he ene s o he Decla a ion o Helsinki. All pa ien s
p o ided in o med consen o pa icipa e in he s udy.
100 subjec s consecu i ely ope a ed o ca a ac su ge y be ween Ma ch 2019 and De-
cembe 2019 a A aba Uni e si y Hospi al we e p ospec i ely ollowed du ing a 12-mon h
pe iod. The inclusion c i e ia we e pa ien s wi h ca a ac and p eope a i e monocula
co ec ed dis ance isual acui y (CDVA) >0.1 logMAR wi h o wi hou co neal as igma ism,
ollowing he s anda ds o clinical p ac ice o he public heal h si e on which he s udy was
conduc ed. Exclusion c i e ia included any ac i e ocula diseases, ch onic u ei is, e inal
degene a ions, glaucoma/ocula hype ension >24 mmHg, pseudoex olia ion synd ome,
ke a oconus, co neal endo helial dys ophies, p e ious in aocula su ge y, clinical his o y
o co neal lase e ac i e su ge y, co neal ec asia, auma, opaci ica ions and he e usal o
sign he in o med consen .
Objec i e (TRK-2P, Topcon Co po a ion, Tokyo, Japan) and subjec i e e ac ions
we e ob ained a all he ollow-up isi s by he same op ome is using he pho op e
and an op o ype cha loca ed a 4 m; no co ec ions o he sphe ical e ac ion o 6 m o
in ini y we e applied as a single o mula o he IOL powe calcula ion used in his s udy.
Changes in co neal powe and as igma ism be ween he p eope a i e and he 12-mon h
isi we e measu ed wi h he Si ius co neal opog aphe (Schwind eye- ech-solu ions
GmbH & Co. KG; Kleinos heim, Ge many). The unco ec ed dis ance isual acui y (UDVA)
was measu ed a 4 m, and he CDVA wi h he subjec i e e ac ion was ob ained a his
dis ance wi hou e gence co ec ion. The con as sensi i i y unc ion (CSF) was measu ed
monocula ly wi h a bes dis ance co ec ion a 4 m wi h he CC-100XP de ice (Topcon
Co po a ion, Tokyo, Japan). The pos e io capsula opaci ica ion and Nd-YAG a es we e
collec ed as dicho omous a iables.
2.2. In aocula Lens and Su ge y
All pa ien s we e implan ed wi h an asphe ical non- o ic hyd ophobic mono ocal
p eloaded IOL (AIALA DRY, LLASHP60-PL, AJL Oph halmic SA; Ala a, Spain), which is
made o hyd ophobic ma e ial wi h a c-loop pla o m wi h an op ical diame e o 6 mm
and o al leng h o 13 mm. The IOL powe was calcula ed using he cons an ecommended
by he manu ac u e (A = 119.7) and he Ba e o mula in eg a ed in he Lens a LS 900
biome e (Haag-S ei AG, Koeniz, Swi ze land). All su ge ies we e conduc ed by di e en
su geons wi h phacoemulsi ica ion h ough a 2.2 mm incision size a empo al loca ion
and while conduc ing a con inuous ci cula capsulo hexis. The lens was emo ed by
phacoemulsi ica ion using he su geon’s p e e ed me hodology and while implan ing
he p eloaded mono ocal IOL. The eco ded in aope a i e in o ma ion was: p esence o
pupilla y p oblems and any complica ions ha occu ed, including loppy i is synd ome
(IFIS), pos e io capsule ea s, zonula dehiscence, i eous p olapse o lens implan a ion
di icul ies, among o he s.
2.3. S a is ical Analysis
The desc ip i e s a is ics a e de ailed in he esul s sec ion as he mean
±
s anda d
de ia ion o no mally dis ibu ed a iables and as he median (in e qua ile- ange) o non-
no mally dis ibu ed ones. The dis ibu ions we e es ed wi h he Kolmogo o –Smi no
es and h ough a his og am inspec ion. The one-sample Wilcoxon signed ank es was
used o es ing he null hypo hesis o he median di e ence o PE equal o ze o in o de
o assess i cons an op imiza ion was equi ed. The median absolu e e o (AE) was
Vision 2022,6, 5 3 o 8
also calcula ed as he absolu e alue o he PE. The s abili y o subjec i e and objec i e
e ac ions was assessed wi h a F iedman es wi h a pos -hoc pai ed compa ison and
Bon e oni co ec ion. Co ela ions be ween he subjec i e e ac ion s abili y and axial
leng h o IOL powe we e assessed wi h he Spea man ho. The assessmen o con ounding
ac o s as co neal powe changes be ween 1 and 12 mon hs was e alua ed wi h he pai ed
- es . The in luence o biome ic pa ame e s and PE was desc ip i ely e alua ed wi h plo s
p e iously desc ibed in he li e a u e [
15
]. The associa ion be ween PCO o Nd:YAG and
PE changes was e alua ed wi h he Fishe ’s exac es . SPSS e sion 24 so wa e (SPSS Inc,
Chicago, IL, USA) was used o he s a is ical analysis. The Re ac i e Analysis oolbox
( 1.0.5) o MATLAB (R2009; Ma hWo ks, Na ick, MA, USA) was used o conduc he
s anda d plo s [16].
3. Resul s
3.1. P edic ion E o
Fi y men and 50 women we e included in he s udy. The demog aphic cha ac e is ics
o he sample a e shown in Table 1. 97% o he eyes achie ed a CDVA
≤
0.2 logMAR
a he 12-mon h ollow-up. The median PEs a one, six and 12 mon hs we e 0.20 (0.38),
0.32 (0.57)
and 0.33 (0.64) D, espec i ely, and we e signi ican ly di e en om 0 o he
h ee ollow-up pe iods (p< 0.05), sugges ing ha cons an op imiza ion was equi ed
o each one o he isi s. On he o he hand, he median AEs a one, six and 12 mon hs
we e
0.33 (0.33)
, 0.41 (0.55) and 0.43 (0.54) D. The pe cen age o eyes in
±
0.50 dec eased
om 79% a one mon h o 68% and 67% a six and 12 mon hs, espec i ely. The pe cen -
age o eyes in
±1.00 D
dec eased om 94% a one mon h o 91% and 90% a six and
12 mon hs, espec i ely.
Table 1. Demog aphic cha ac e is ics o he sample.
Va iable Mean ±SD Median [IQR] Range [Min–Max]
Age 73 ±7 74 (10) 52–90
An e io Chambe Dep h (mm)
3.25 ±0.38 3.27 (0.49) 2.46–4.57
Axial Leng h (mm) 23.28 ±0.93 23.29 (1.23) 21.19–25.73
A e age Co neal Powe (D) 43.91 ±1.38 43.87 (1.90) 41.10–47.82
Co neal As igma ism (D) 0.79 ±0.59 0.69 (0.60) 0.02–3.74
Co neal diame e (mm) 11.97 ±0.43 12 (0.58) 10.64–13.10
Lens Thickness (mm) 4.46 ±0.45 4.5 (0.64) 3.31–5.57
In aocula Lens Powe (D) 22.48 ±2.63 22.5 (3) 14–31
Ta ge Re ac ion (D) −0.19 ±0.12 −0.17 (0.19) −0.52–0.06
SD: S anda d de ia ion; IQR: In e qua ile ange.
A s a is ically signi ican hype opic shi was ound be ween one mon h and six
mon hs, ei he o objec i e o subjec i e e ac ion; howe e , he e ac i e e o was s able
be ween six and 12 mon hs (Figu e 1A). The O-Rx was mo e myopic han he S-Rx o
all he pos ope a i e isi s. The S-Rx was s able in 39% o eyes, 44% showed a hype opic
endency and 17% a myopic endency. Signi ican co ela ions we e ound be ween he
di e ence in S-Rx (12–1 mon hs) and IOL powe ( ho = 0.21, p= 0.03) o AXL ( ho =
−
0.29,
p= 0.007) (Figu e 1B). The mean co neal powe a 12 mon hs was 43.88
±
1.37 D, e y close
o he epo ed p eope a i e one o 43.91±1.38 D ( = −0.74, p= 0.46).
Figu e 1C,D shows he pe cen age o eyes ou side +0.50 D and +1.00 D, espec i ely,
s a i ied acco ding o he pe cen iles o dis ibu ion o biome ic pa ame e s in he heal hy
popula ion. A ho izon al c oss line inside he plo ep esen s he achie ed pe cen age
conside ing all he eyes, and ba s o e passing his line desc ibe a highe p obabili y o
he o mula ailing in a pa icula pe cen ile. The eyes wi h sho e AXLs also showed an
inc ease o he PE (25% o 50%), in ag eemen wi h ha shown in Figu e 1B.
Vision 2022,6, 5 4 o 8
Vision 2022, 6, x FOR PEER REVIEW 4 o 9
Figu e 1C,D shows he pe cen age o eyes ou side +0.50 D and +1.00 D, espec i ely,
s a i ied acco ding o he pe cen iles o dis ibu ion o biome ic pa ame e s in he
heal hy popula ion. A ho izon al c oss line inside he plo ep esen s he achie ed pe -
cen age conside ing all he eyes, and ba s o e passing his line desc ibe a highe p oba-
bili y o he o mula ailing in a pa icula pe cen ile. The eyes wi h sho e AXLs also
showed an inc ease o he PE (25% o 50%), in ag eemen wi h ha shown in Figu e 1B.
Figu e 1. (A) S abili y o sphe ical equi alen e ac ion; (B) Rela ionship be ween axial leng h and
a ia ion in sphe ical equi alen ; (C) Assessmen o % o eyes ou side ±0.50 D and (D) ou side ±1.00
D h ough pe cen iles de ined om he heal hy ca a ac popula ion.
3.2. S anda d Resul s
3.2.1. Sa e y
No su ge y complica ions we e epo ed beyond 11 eyes wi h IFIS wi hou a ec ing
CDVA, 10 eyes wi h CDVA ≤ 0 logMAR and one eye wi h CDVA equal o 0.2 logMAR.
Nine eyes p esen ed PCO a six mon hs, wo o hem equi ing Nd:YAG. The cumula ed
numbe o eyes p esen ing PCO a 12 mon hs was inc eased o 37 eyes, se en eyes equi -
ing Nd:YAG. Only one eye los wo lines o CDVA a 12 mon hs in compa ison o he
p eope a i e isi , mainly due o PCO, his being one o he p e iously desc ibed eyes
equi ing Nd:YAG.
3.2.2. E icacy and P edic abili y
Figu e 2A,B shows he s anda d e icacy plo s; he median (IQR) o UDVA and
CDVA we e 0.1 (0.29) and 0 (0.12) logMAR, espec i ely. Figu e 2C,D shows he sphe ical
Figu e 1.
(
A
) S abili y o sphe ical equi alen e ac ion; (
B
) Rela ionship be ween axial leng h and
a ia ion in sphe ical equi alen ; (
C
) Assessmen o % o eyes ou side
±
0.50 D and (
D
) ou side
±1.00 D h ough pe cen iles de ined om he heal hy ca a ac popula ion.
3.2. S anda d Resul s
3.2.1. Sa e y
No su ge y complica ions we e epo ed beyond 11 eyes wi h IFIS wi hou a ec ing
CDVA, 10 eyes wi h CDVA
≤
0 logMAR and one eye wi h CDVA equal o 0.2 logMAR. Nine
eyes p esen ed PCO a six mon hs, wo o hem equi ing Nd:YAG. The cumula ed numbe
o eyes p esen ing PCO a 12 mon hs was inc eased o 37 eyes, se en eyes equi ing Nd:YAG.
Only one eye los wo lines o CDVA a 12 mon hs in compa ison o he p eope a i e isi ,
mainly due o PCO, his being one o he p e iously desc ibed eyes equi ing Nd:YAG.
3.2.2. E icacy and P edic abili y
Figu e 2A,B shows he s anda d e icacy plo s; he median (IQR) o UDVA and
CDVA we e 0.1 (0.29) and 0 (0.12) logMAR, espec i ely. Figu e 2C,D shows he sphe ical
equi alen and esidual e ac i e cylinde dis ibu ions, and he esidual endency o he
cylinde is shown in Figu e 2F. 61% and 31% o eyes esul ed in a e ac i e as igma ism
abo e 0.50 D and 1.00 D a 12 mon hs, close o he 66% and 20% shown p eope a i ely by
co neal as igma ism. The monocula con as sensi i i y unc ion wi h he bes dis ance
co ec ion is ep esen ed in Figu e 2E. No signi ican associa ion was ound be ween he
PE a ia ion om one o 12 mon hs and ei he he PCO mani es a ion (p= 0.68) o Nd:YAG
(p= 0.09); he e o e, he PE a ia ion wi h a ollow-up was no due o Nd:YAG.
Vision 2022,6, 5 5 o 8
Vision 2022, 6, x FOR PEER REVIEW 5 o 9
equi alen and esidual e ac i e cylinde dis ibu ions, and he esidual endency o he
cylinde is shown in Figu e 2F. 61% and 31% o eyes esul ed in a e ac i e as igma ism
abo e 0.50 D and 1.00 D a 12 mon hs, close o he 66% and 20% shown p eope a i ely by
co neal as igma ism. The monocula con as sensi i i y unc ion wi h he bes dis ance
co ec ion is ep esen ed in Figu e 2E. No signi ican associa ion was ound be ween he
PE a ia ion om one o 12 mon hs and ei he he PCO mani es a ion (p = 0.68) o Nd:YAG
(p = 0.09); he e o e, he PE a ia ion wi h a ollow-up was no due o Nd:YAG.
Figu e 2. S anda d ou comes a a 12-mon h isi o monocula ision. (A) E icacy h ough pos op-
e a i e unco ec ed (UDVA) e sus co ec ed (CDVA) pos ope a i e isual acui ies; (B) di e ence
o lines be ween pos ope a i e UDVA and CDVA; (C) sphe ical equi alen om subjec i e e ac-
ion; (D) e ac i e as igma ism dis ibu ion; (E) con as sensi i i y unc ion wi h bes dis ance co -
ec ion; (F) Vec o analysis o pos ope a i e e ac i e as igma ism.
Figu e 2.
S anda d ou comes a a 12-mon h isi o monocula ision. (
A
) E icacy h ough pos ope -
a i e unco ec ed (UDVA) e sus co ec ed (CDVA) pos ope a i e isual acui ies; (
B
) di e ence o
lines be ween pos ope a i e UDVA and CDVA; (
C
) sphe ical equi alen om subjec i e e ac ion;
(
D
) e ac i e as igma ism dis ibu ion; (
E
) con as sensi i i y unc ion wi h bes dis ance co ec ion;
(F) Vec o analysis o pos ope a i e e ac i e as igma ism.
4. Discussion
S anda ds o e alua ing he PE om se e al o mulas ha e been ecen ly published
wi hou a uni o m consensus abou he amoun o ime a e su ge y ha is equi ed
o measu e he e ac i e e o . While Ho e and Sa ini ecommended h ee mon hs
Vision 2022,6, 5 6 o 8
and a leas wo weeks o one mon h [
7
], Holladay e al. [
6
] we e mo e conse a i e and
sugges ed a leas six mon hs o achie e an e ec i e lens posi ion (ELP) s abiliza ion. In
ou s udy, we e alua ed he e ac i e e o s abiliza ion, ob aining a be e ag eemen
wi h Holladay e al. [
6
]. This does no mean ha s abiliza ion canno be p oduced ea lie
han six mon hs [
17
], bu in some cases, as in ou s udy, longe pe iods o ime can be
equi ed. Bo h s anda d p oposals ag ee ha objec i e e ac ion should no be used o
e alua e he PE [
6
,
7
]; howe e , he e a e s ill au ho s epo ing he PE in e ms o objec i e
e ac ion [
12
–
14
]. Ou esul s ha e shown ha a ia ions o SE can be de ec ed wi h
ei he objec i e o subjec i e e ac ion bu ha objec i e e ac ion esul s in mo e myopic
esiduals, some hing ha can be less a ec ed by open- ield e ac o s [
18
]. The e o e,
au ho s should a oid he use o objec i e e ac ion o assess he PE.
The hype opic shi ob ained in ou s udy sugges s a backwa d mo emen o he IOL
a e he i s mon h. Koeppl e al. [
19
] epo ed a myopic shi due o he dec ease o
he dis ance be ween he an e io co neal e ex and he an e io in aocula lens su ace,
known as he ac ual lens posi ion (ALP), du ing he i s week a e su ge y, in ag eemen
wi h Pe e nel e al. [
20
]. The la e also epo ed an inc ease o he ALP and a hype opic
shi om one week o h ee mon hs, in ag eemen wi h he indings o ou s udy. These
shi s ha e been mainly explained by he ansi ion be ween he op ic and hap ic design,
wi h a highe mo emen in IOLs wi h sha p edges [
20
], by using single o mul i-piece
pla o ms [
21
], depending on he c-loop o ou -poin pla o ms [
22
] o on he a ea o
connec ion be ween he hap ic and he op ic design [
23
]. The ela ionships be ween he
AXL and IOL powe wi h he hype opic shi sugges ha his e ec should be pa icula ly
in es iga ed in u u e s udies, pu ing special emphasis on sho eyes implan ed wi h a high
IOL powe o which he ALP a ia ion can p oduce a highe change in SE han IOLs wi h
a lowe powe . Al hough conclusions could no be made h ough he desc ip i e analysis
o PE o se e al biome ic pa ame e s, ou esul s also sugges ha eyes wi h longe LT
and bigge WTW should be u he explo ed in u u e s udies, ha ing no p e iously been
desc ibed o he Ba e o mula [15]. On he o he hand, in ou s udy, he pe cen ages o
eyes in
±
0.50 D and
±
1.00 D a e e ac ion s abiliza ion we e 67% and 90%, espec i ely.
This pe cen age could be imp o ed wi h cons an op imiza ion, bu his op imiza ion
should be conduc ed wi h 6-mon h e ac ions a leas . A e op imiza ion, he Ba e
accu acy will esul in pe cen ages abo e 79% and 94%, espec i ely, which we e shown a
one mon h and o which cons an op imiza ion was also equi ed. This expec ed accu acy
o he Ba e o mula a e op imiza ion is consis en wi h he p e iously epo ed da a in
he li e a u e o mono ocal IOLs [24,25].
Wi h ega d o he s anda d esul s o his pa icula IOL, he Nd:YAG equi ed a es
we e sligh ly highe han he expec ed ones o hyd ophobic IOLs acco ding o he esul s
epo ed by he Royal College o Oph halmologis s in he 2021 audi [
26
]. 7% o eyes in
ou s udy equi ed Nd:YAG, whe eas o hyd ophobic IOLs, 1% equi ed i in his audi .
Al hough we epo ed 37% o PCO a 12 mon hs, his esul ed in a dec ease o CDVA o
≥
2 lines in only six eyes om he o al sample o 100. This is he eason why CDVA and
CSF showed mean no mal esul s, he la e in compa ison wi h o he s udies using he
same CSF es [
27
–
29
]. I is impo an o no e ha hese CSF esul s could no be compa ed
wi h hose epo ed by o he CSF es s, since he CC-100XP de ice usually o e es ima es
he CSF in compa ison wi h o he es s such as he FACT, CSV-1000 o ClinicCSF [30].
Ou s udy has some limi a ions o ema k on. Fi s , no measu emen s we e aken
o he ALP o pupil diame e du ing he ollow-up isi s. Thus, e en hough we ha e
hypo hesized ha an ALP inc ease be ween one mon h and six mon hs migh explain he
hype opic shi , his should be demons a ed in u u e s udies wi h he measu emen o he
eal ALP. I is impo an o no e ha he in aocula lens induced a sphe ical abe a ion wi h
he pupil diame e and in aocula lens powe being unknown, and we canno he e o e
hypo hesize abou hei possible in luence on he esul s. Fu he mo e, measu emen s
we e no ob ained a h ee mon hs, and we can say ha he e ac i e e o appea s o
be s abilized be ween one and six mon hs bu no a one mon h, a leas o ou sample
Vision 2022,6, 5 7 o 8
and o his IOL. O he con ounding ac o s, no measu ed in he cu en s udy, such as
he capsulo hexis shape, migh ha e had some in luence on he hype opic shi beyond
he hap ic design [
31
]. Second, he decision c i e ia o implan ing he IOLs was limi ed
by he possibili ies o e ed o pa ien s in acco dance wi h he public heal h sys em. Due
o his eason, a high pe cen age o eyes wi h a co neal as igma ism highe han 0.75 D
we e implan ed wi h a sphe ical IOL ins ead o a o ic IOL, which would lead o a be e
pos ope a i e UDVA. This explains why only 53% o eyes ob ained an UDVA wi h a
maximum de ia ion o one line o isual acui y in compa ison o CDVA. Howe e , his
second limi a ion has no in luence on he PE assessmen , which is e alua ed h ough he
sphe ical equi alen e ac ion.
5. Conclusions
In conclusion, ou esul s sugges ha some cau ion should be aken in s udies e-
po ing PE wi h e ac i e e o s measu ed ei he objec i ely o a a 1-mon h ollow-up, a
leas o his pa icula IOL model, which showed a hype opic shi om one mon h o six
mon hs. Su geons using his IOL should op imize i s cons an wi h a subjec i e e ac ion
ob ained a six mon hs, e en hough a pe iod o ime be ween h ee and six mon hs, no
e alua ed in his s udy, migh also be alid. On he o he hand, his is he i s s udy o
epo s anda d esul s o his IOL model, which could be o special in e es o su geons
who a e conside ing o use his IOL.
Au ho Con ibu ions:
Concep ualiza ion, B.M.-M. and G.G.-A.; me hodology, R.B.-M., D.C.-O., I.O.,
P.J.G.-G. and J.G.-F.; o mal analysis, B.M.-M., G.G.-A. and M.R.-V.; in es iga ion, R.B.-M., D.C.-O.,
I.O., P.J.G.-G. and J.G.-F.; esou ces, B.M.-M., G.G.-A. and J.F.; da a cu a ion, R.B.-M., D.C.-O., I.O.,
P.J.G.-G., J.G.-F., B.M.-M., G.G.-A. and M.R.-V.; w i ing— e iew and edi ing, R.B.-M., D.C.-O., I.O.,
P.J.G.-G., J.G.-F. and J.F.; supe ision, B.M.-M. and J.F.; p ojec adminis a ion, G.G.-A.; unding
acquisi ion, G.G.-A. All au ho s ha e ead and ag eed o he published e sion o he manusc ip .
Funding:
This wo k has ecei ed inancial suppo om he Med ech Ini ia i e, p omo ed by he
Depa men o Heal h and Lehendaka i za h ough he Basque Go e nmen ’s Inno a ion Fund.
Ins i u ional Re iew Boa d S a emen :
The s udy was app o ed by he D ug Resea ch E hics
Commi ee o Euskadi (PS2018031) and was conduc ed in adhe ence wi h he ene s o he Decla a ion
o Helsinki. All pa ien s p o ided in o med consen o pa icipa e in he s udy.
In o med Consen S a emen :
In o med consen was ob ained om all subjec s in ol ed in he s udy.
Da a A ailabili y S a emen :
The da a ha suppo he indings o his s udy a e a ailable om he
au ho upon eques .
Acknowledgmen s:
We would like o hank o C is ian Dalmasso and he Clinical Managemen Uni
om he OSI A aba (Vi o ia-Gas eiz, Spain) o hei con ibu ion in making his s udy possible.
Con lic s o In e es : The au ho s decla e no con lic o in e es .
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