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Oph halmic Physiol Op . 2024;44:876–883.wileyonlinelib a y.com/jou nal/opo
ORIGINAL ARTICLE
Assessing neophy e esponse o daily disposable silicone
hyd ogel con ac lenses: A andomised clinical ial
in es iga ion o e one mon h
JacoboGa cia- Quei uga1,2 | HugoPena- Ve deal1,2 | Dolo esFe ei o- Figuei as1 |
Ve onicaNoya- Padin1,2 | Ma ia J.Gi aldez1,2 | E aYeb a- Pimen el1,2
Recei ed: 12 Feb ua y 2024
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Accep ed: 24 Ap il 2024
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Published online: 7 May 2024
DOI: 10.1111/opo.13328
This is an open access a icle unde he e ms o he C ea i e Commons A ibu ion-NonComme cial-NoDe i s License, which pe mi s use and dis ibu ion in any medium,
p o ided he o iginal wo k is p ope ly ci ed, he use is non-comme cial and no modi ica ions o adap a ions a e made.
© 2024 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.
1Depa amen o de Física Aplicada (Á ea
de Op ome ía), Facul ade de Óp ica e
Op ome ía, Uni e sidade de San iago de
Compos ela, San iago de Compos ela, Spain
2AC- 24 Op ome ía, Ins i u o de In es igación
Sani a ia de San iago de Compos ela (IDIS),
San iago de Compos ela, Spain
Co espondence
Jacobo Ga cia- Quei uga, Facul ad de Óp ica
y Op ome ía, Campus Vida s/n, Uni e sidad
de San iago de Compos ela, A Co uña,
Galicia, Spain.
Email: jacobo[email p o ec ed]
Abs ac
Objec i e: This andomised clinical ial assessed he impac on symp oms, ea
ilm dynamics and ocula su ace in eg i y o daily disposable silicone- hyd ogel
con ac lenses (CLs) o e a mon h, paying special a en ion o lid wipe epi heli-
opa hy (LWE) and i s implica ions o CL discom o .
Me hods: Neophy e CL wea e s (n = 44, 21.09 ± 5.00 yea s old) we e andomly as-
signed o ei he he expe imen al (n = 24) o con ol g oup (n = 20). Pa icipan s
assigned o he expe imen al g oup we e equi ed o wea daily disposable CLs
o 1 mon h o a leas 8 h/day and 6 days/week. All pa icipan s we e heal hy sub-
jec s (no his o y o ocula su ge y o ac i e ocula disease) wi h sphe ical e ac i e
e o s be ween −8.00 and +5.00 D and cylind ical powe <0.75 D. A he baseline
and 1- mon h sessions, he D y Eye Ques ionnai e 5 (DEQ- 5) was comple ed, o-
ge he wi h he measu emen o ea ilm osmola i y wi h he Tea Lab osmom-
e e , ea meniscus heigh (TMH) and lipid laye pa e n (LLP) using a sli - lamp wi h
Tea scope Plus a ached, luo escein b eak- up ime (FBUT), maximum blink in e -
al (MBI), co neal s aining wi h luo escein unde cobal blue ligh and LWE wi h
lissamine g een unde sli lamp and halogen whi e ligh .
Resul s: A he baseline session, LWE showed a nega i e co ela ion wi h
DEQ- 5 ( = −0.37, p = 0.02). Signi ican di e ences in FBUT and LWE (p = 0.04)
and a posi i e co ela ion be ween LWE and DEQ- 5 ( = 0.49, p = 0.007) we e ob-
se ed a 1 mon h. In asession analysis a 1 mon h showed signi ican di e -
ences be ween he expe imen al and con ol g oups in DEQ- 5, FBUT and LWE
(all p ≤ 0.02). In e session analysis in he expe imen al g oup showed a ia ions
in DEQ- 5, FBUT and LWE (all p ≤ 0.02) bu no signi ican a ia ion in he con ol
g oup (all p ≥ 0.11).
Conclusion: The p esence o LWE was signi ican ly co ela ed wi h highe symp-
om alues in he DEQ- 5. Also, pa icipan s in he expe imen al g oup p esen ed
highe alues o LWE a e 1 mon h o CL wea , in compa ison wi h he con ol
g oup.
KEYWORDS
con ac lenses, daily disposable lenses, in e session, lid wipe epi heliopa hy, andomised clinical
ial
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GARCIA- QUEIRUGA e al.
INTRODUCTION
O e he pas ew decades, he e has been a consis en
inc ease in he use o con ac lenses (CLs) o co ec e-
ac i e e o s.1,2 Despi e he a ailabili y o new CL ma e-
ials, many wea e s equen ly expe ience issues ha may
cause hem o discon inue lens wea al oge he .3–5 Con ac
lens discom o (CLD) is a common issue ha o en esul s
in educed wea ing ime, a sho e in e al be o e a lens
change is equi ed o e en d opping ou o lenses al o-
ge he .3–5 The Tea Film and Ocula Su ace Socie y (TFOS)
p oposed a de ini ion o his condi ion a e an ex ensi e
li e a u e e iew as ollows: ‘Con ac lens discom o is a
condi ion cha ac e ised by episodic o pe sis en ad e se
ocula sensa ions ela ed o lens wea , ei he wi h o wi h-
ou isual dis u bance, esul ing om educed compa ibil-
i y be ween he con ac lens and he ocula en i onmen ,
which can lead o dec eased wea ing ime and discon inu-
a ion o con ac lens wea ’.6–8
Changes in he ocula su ace can impac he lens wea -
e 's com o . A heal hy su ace mic obio a is impo an o
p ope in e ac ion be ween he CL and he ocula su ace,
as well as o educe he po en ial occu ence o se ious
issues du ing CL wea .9–11 One ac o ha a ec s ocula
discom o is lid wipe epi heliopa hy (LWE), whose p e a-
lence anges om 67% o 80% in symp oma ic CL wea e s,
bu is less han 32% in asymp oma ic wea e s.12 LWE e-
sul s om he ic ion o he eyelid o e he ocula su ace
when he ea ilm hins.13 The use o CLs also al e s ea
ilm s abili y and ea olume, wi h dec eased alues being
obse ed a e CL emo al.14–16
Following he sugges ion made by he TFOS CLD wo k-
shop, his andomised clinical ial aimed o assess he im-
pac o a daily disposable silicone- hyd ogel CL (somo ilcon
A) on symp oms, ea ilm dynamics and ocula su ace
in eg i y, when compa ed wi h non- CL wea e s o e he
cou se o a mon h, paying special a en ion o changes in
LWE and i s po en ial implica ions o CLD.
MATERIALS AND METHODS
Sample
A sample size calcula ion was pe o med using PS Powe
and Sample Size Calcula ions So wa e Ve sion 3.1.2 (bios
a . app. umc. o g/ wiki/ Main/ Powe Sampl eSize ). This s udy
in ol ed con inuous esponse a iables being ob ained
om pai ed sessions o examine he abili y o de ec a ia-
ions in LWE.12,17 A li e a u e e iew o LWE sugges ed ha
he mean s anda d de ia ion (SD) o epea ed measu es
ollowed a no mal dis ibu ion wi h a alue o 0.7 poin s,
while he minimal clinically signi ican di e ence was hal
a g ade poin .17 The e o e, o achie e a s a is ical powe
o 0.80 o ejec ing he null hypo hesis wi h a Type I e o
p obabili y o 0.05, a minimum o 17 pa icipan s was
equi ed. Allowing o a 20% po en ial loss o ollow- up,
he o al sample size needed was 21 pa icipan s.
A o al o 44 Caucasian neophy e CL pa icipan s
(70.45% women) we e ec ui ed, ha ing a mean age (±SD)
o 21.09 ± 5.00 yea s. All pa icipan s had no wo n CL p e-
iously, we e equi ed o ha e a sphe ical e ac i e e o
be ween −8.00 o +5.00 D, <0.75 D o cylind ical e o and
ha e bes - co ec ed isual acui y o a leas 0.9 decimal
acui y (6/6.67) in hei wo se eye.18 In addi ion, pa icipan s
had o p esen wi h heal hy eyes and no sys emic disease
ha migh a ec CL wea (e.g., alle gies, diabe es melli us,
heuma oid a h i is o hy oid disease) in o de o pa ici-
pa e. All subjec s p o ided w i en in o med consen and
he p o ocol adhe ed o he ene s o he Decla a ion o
Helsinki, i was app o ed by he Bioe hics Commi ee o
he Uni e sidade de San iago de Compos ela.
S udy design
All pa icipan s we e scheduled o h ee sessions,
namely he inclusion, baseline and 1- mon h sessions.
Subjec i e e ac ion, ke a ome y, ho izon al isible i is
diame e and bes - co ec ed isual acui y we e assessed
du ing he inclusion session. Pa icipan s we e hen
andomly assigned o ei he he expe imen al (n = 24)
o con ol g oup (n = 20). Those assigned o he expe i-
men al g oup we e equi ed o wea daily disposable CL
o 1 mon h, whe eas he con ol g oup did no use any
ype o CL du ing he s udy. A he baseline and 1- mon h
sessions, he D y Eye Ques ionnai e 5 (DEQ- 5),19 ea os-
mola i y, ea meniscus heigh (TMH), lipid laye pa e n
(LLP), luo escein b eak- up ime (FBUT), maximum blink
in e al (MBI), co neal s aining and LWE we e measu ed.
Pa icipan s in he expe imen al g oup also comple ed
he Con ac Lens D y Eye Ques ionnai e 8 (CLDEQ- 8)
a e 1 mon h.20,21 The same examine pe o med he
Key poin s
• A e 1 mon h, neophy e con ac lens wea e s
demons a ed inc eased ocula discom o and
lid wipe epi heliopa hy, as well as dec eased
ea ilm b eak- up ime compa ed wi h he con-
ol g oup.
• The p esence o lid wipe epi heliopa hy was
co ela ed wi h g ea e symp oma ology, high-
ligh ing i s ele ance in con ac lens discom o .
• The indings unde sco e he impo ance o
moni o ing lid wipe epi heliopa hy in daily dis-
posable con ac lens wea e s o mi iga e po en-
ial discom o and imp o e o e all sa is ac ion
wi h lens wea .
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NEOPHYTE RESPONSE TO DAILY SIHI CL AFTER ONE MONTH
measu emen s on bo h eyes o each pa icipan , while
a second masked obse e analysed he collec ed da a.
The i s examine assigned an alphanume ic code o
each ideo o he second masked examine o analyse.
This examine did no know whe he he pa icipan s
belonged o he expe imen al o con ol g oup, as he
p ocedu es we e pe o med and eco ded wi hou CL in
place.
Con ac lens ma e ial and wea ing
ins uc ions
Daily disposable sphe ical silicone- hyd ogel CL we e i -
ed o all pa icipan s in he expe imen al g oup. These CL
we e composed o somo ilcon A (coope isi on. com) ha
inco po a es silicone monome s, N- inylpy olidone and
ime hylsiloxane, and we e app o ed o dis ibu ion by
he Uni ed S a es Food and D ug Adminis a ion (FDA).14,22
The p ope ies o hese CLs we e 56% wa e con en , 8.6-
mm base cu e, 14.1 mm diame e , Dk/ 86 · 10−9 cm/s · mL
O2/mL · mmHg and modulus o 0.5 MPa. These lenses we e
selec ed o he cu en in es iga ion because hey a e
a ailable wo ldwide and ep esen a cos - e ec i e daily
disposable silicone- hyd ogel CL op ion. All pa icipan s
we e ins uc ed o apply he CL di ec ly om he o iginal
solu ion, o wea he CL o a leas 6 days pe week and 8 h
pe day.
D y eye symp oma ology and CLD
Ocula symp oms ela ing o d y eye we e assessed wi h
he DEQ- 5 ques ionnai e in all pa icipan s du ing each
session.19 The DEQ- 5 is a simple o m ha add esses he
mos common symp oms ela ed o ocula complain s: eye
discom o , d yness and excessi e wa e ing. Addi ionally,
he CLDEQ- 8 ques ionnai e was comple ed by pa icipan s
in he expe imen al g oup a e 1 mon h o CL wea .20,21
The CLEDQ- 8 is a ques ionnai e de eloped speci ically o
assess he symp oma ology o CL wea e s. I includes h ee
addi ional ques ions compa ed wi h he DEQ- 5 ela ed o
CL wea ( equency o changeable o blu y ision, clos-
ing eyes and emo ing lenses). This addi ion was made
due o he simila i y in symp oms be ween CL wea e s
and indi iduals wi h d y eye disease. DEQ- 5 and CLDEQ- 8
sco es we e calcula ed as he sum o he alues o each
esponse.19–21
Tea ilm and ocula su ace pa ame e s
P ocedu es we e pe o med om leas o mos in asi e
in o de o a oid al e a ions due o he measu emen s.
Tea ilm osmola i y was measu ed wi h he Tea Lab
(Tu ke a Medical, uke a. com/ ea l ab/ ) by de e min-
ing he elec ical impedance. The same Tea Lab ca d lo
numbe s we e used o a oid possible a ia ion.23 TMH
images we e cap u ed using a Topcon DC- 4 came a
(Topcon Heal hca e, opco nheal hca e. eu/ en_ EU/ p odu
c s/ dc- 4) a ached o a Topcon SL- D4 sli lamp ( opco
nheal hca e. eu/ en_ EU/ p odu c s/ sl- d4) using illumina-
ion om a Keele Tea scope Plus (keele . co. uk) in e e -
ome e .24,25 These images we e measu ed wi h he open
sou ce ImageJ so wa e (Na ional Ins i u es o Heal h,
imagej. ne / ij/ ).25 While he Tea scope was con igu ed
on he SL- D4, he LLP was ideo cap u ed and classi ied
using he Guillon scheme.26 Subsequen ly, luo escein
was ins illed on o he ocula su ace wi h a hyd a ed lu-
o escein s ip (Con aca e Oph halmics and Diagnos ics,
ca eg oupi ol. com/ p odu c s/ oph h almic - solu ions/ diagn
os ic - s ips/ luo- s ips/ ). A e he applica ion o luo-
escein, FBUT and MBI we e de e mined wi h he sli
lamp and ideo cap u ed h ee imes. The wo closes
measu es o he FBUT and MBI we e used o ob ain he
mean alue, as done p e iously.27 Co neal s aining was
also ideo cap u ed wi h he sli lamp and DC- 4 cam-
e a, wi h he pa icipan s looking in he i e gaze posi-
ions. Videos o co neal s aining we e g aded ollowing
he Ox o d scheme.28 Finally, a hyd a ed lissamine g een
s ip was applied o he ocula su ace o LWE e alua-
ion. Pa icipan s we e ins uc ed o close and mo e
hei eyes o dis ibu e he lissamine g een dye. Only he
uppe eyelid s aining was e alua ed and g aded ollow-
ing he ecommenda ions o Ko b e al.,29,30 which quan-
i ies he ho izon al leng h and he sagi al heigh o he
s aining. LWE ho izon al leng h was g aded in ou le els
as ollows: g ade 0 (<2 mm), g ade 1 (2–4 mm), g ade 2
(5–9 mm) and g ade 3 (>10 mm). The sagi al heigh o he
LWE was also g aded in ou le els: g ade 0 (<25%), g ade
1 (25%–50%), g ade 2 (50%–<75%) and g ade 3 (>75%).
This g ading was used o he s a is ical analysis, aking
he a e age o he wo measu emen s: g ade 1 (0.25–1),
g ade 2 (1.25–2) and g ade 3 (2.25–3).30
S a is ical analysis
SPSS s a is ical so wa e .25.0 o Windows (ibm. com/
p odu c s/ spss- s a i s ics ) was used o da a analysis.
Signi icance was se a p ≤ 0.05 o all analyses. Ini ially,
he no mal dis ibu ion o he di e en pa ame e s was
checked using he Shapi o–Wilk es o each eye sepa-
a ely.31 Pa ame ic analyses we e pe o med on osmola -
i y and TMH (Shapi o–Wilk, p ≥ 0.07), while non- pa ame ic
analyses we e assigned o DEQ- 5, CLDEQ- 8, LLP, FBUT,
MBI, co neal s aining and LWE (Shapi o–Wilk, all p ≤ 0.01).
Con inuous a iables we e analysed using a pai ed - es ,
unpai ed - es o ANOVA when hey ollowed a no mal dis-
ibu ion, whe eas non- no mal dis ibu ed a iables we e
analysed wi h he K uskal–Wallis es , he Mann–Whi ney
U es o Spea man co ela ions. Addi ionally, ca ego ical
a iables we e analysed using c oss ables and Fishe 's
exac es . Fi s , di e ences be ween he igh and le
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879
GARCIA- QUEIRUGA e al.
eyes we e measu ed o bo h pa ame ic (unpai ed - es ,
all p ≥ 0.37) and non- pa ame ic a iables (Mann–Whi ney
U es and Fishe 's exac es , all p ≥ 0.25) (Table1). Due o
he absence o s a is ically signi ican di e ences, only he
igh eye da a we e analysed o mi iga e s a is ical o e -
es ima ion.31,32 Subsequen ly, he associa ion be ween
he LWE g ades and he o he pa ame e s was analysed
o bo h he baseline and 1- mon h sessions. Finally, he
compa ison o each pa ame e was assessed be ween he
wo g oups in session- by- session pai s (in asession anal-
ysis). Pai wise di e ences be ween he wo g oups we e
assessed using he unpai ed - es o pa ame ic pa am-
e e s and he Mann–Whi ney U es o non- pa ame ic
pa ame e s.31 In a subsequen analysis, compa ison o all
pa ame e alues be ween sessions in bo h g oups was
ca ied ou (in e session analysis). Di e ences in esul s
ob ained a he baseline and he 1- mon h sessions we e
e alua ed using he pai ed - es (pa ame ic pa ame e s)
o he Wilcoxon es (non- pa ame ic pa ame e s) o e-
pea ed measu emen s.31
RESULTS
Desc ip i e s a is ics o igh and le eye da a a e shown
in Table1. Due o he pa ame ic o non- pa ame ic na u e
o he da a, all ables show ei he he mean ± SD o he me-
dian and in e qua ile ange (IQR).
Associa ion be ween LWE and he
pa ame e s s udied
A he baseline session, no signi ican di e ences we e
ound o any o he pa ame e s s udied when g ouped
by he se e i y o LWE (ANOVA, he K uskal–Wallis es
o Fishe 's exac es , all p ≥ 0.11). Spea man co ela ions
showed no signi ican co ela ions be ween any o he
pa ame e s and he LWE se e i y (Spea man co ela ion,
all p ≥ 0.26). Howe e , DEQ- 5 alues we e nega i ely
co ela ed wi h he LWE g ades (Spea man co ela ion,
= −0.37, p = 0.02). A he 1- mon h session, signi ican di -
e ences we e ound o FBUT as a unc ion o he LWE
g ades (K uskal–Wallis es , p = 0.04). No o he pa ame e s
showed signi ican di e ences be ween he LWE se e i y
g ades a he 1- mon h session (ANOVA es , he K uskal–
Wallis es o Fishe 's exac es , all p ≥ 0.07). A signi ican
posi i e co ela ion a he 1- mon h session (Spea man
co ela ion) was ound be ween he LWE se e i y and
DEQ- 5 alues (Spea man co ela ion, = 0.49, p = 0.007).
No o he pa ame e showed a signi ican co ela ion wi h
he LWE g ades (Spea man co ela ion, all p ≥ 0.21).
In asession analysis
No signi ican di e ences we e obse ed be ween he ex-
pe imen al and con ol g oups a he baseline session o
any o he measu ed pa ame e s (unpai ed - es , o Mann–
Whi ney U es , all p ≥ 0.09; see Table2). A he 1- mon h
session, pai wise analysis be ween he g oups showed
signi ican di e ences in DEQ- 5, FBUT and LWE (Mann–
Whi ney U es , o Fishe 's exac es , all p ≤ 0.03; Table3).
No o he signi ican di e ences be ween he expe imen-
al and con ol g oups we e no ed a he 1- mon h ses-
sion (Mann–Whi ney U es , Fishe 's exac es o unpai ed
- es , all p ≥ 0.12; Table3).
In e session analysis
The in e session analysis pe o med in he con ol g oup
be ween he baseline and he 1- mon h session showed no
signi ican di e ences in he s udied pa ame e s (Wilcoxon
es o pai ed - es , all p ≥ 0.11). In he expe imen al g oup,
he compa ison o he baseline and 1- mon h sessions
showed s a is ically signi ican di e ences in DEQ- 5, TMH,
FBUT and LWE (Wilcoxon es o pai ed - es , all p ≤ 0.03). No
TABLE 1 Desc ip i e s a is ics and analysis o di e ences be ween he igh and le eyes o he sample.
n
Righ eye
n
Le eye
pMean ± SD o median (IQR) Mean ± SD o median (IQR)
Osmola i y (mOsm/L) 44 313.52 ± 11.70 43 311. 23 ± 11.9 4 0.37a
TMH (mm) 43 0.13 ± 0.04 43 0.13 ± 0.04 0.69a
LLP (Guillon scheme) 44 2 (2–2) 43 2 (2–3) 0.97c
FBUT (s) 43 9.96 (5.33–14.67) 40 8.17 (5.08–12.92) 0.25b
MBI (s) 43 14 (11–19.67) 40 13.50 (10.67–20) 0.95b
Co neal s aining (Ox o d scheme) 39 0 (0–1) 39 0 (0–1) 0.19c
LWE g ade (Ko b Scheme) 44 0 (0–1) 43 0 (0–1) >0.99c
Abb e ia ions: DEQ- 5, D y Eye Ques ionnai e 5; FBUT, luo escein b eak- up ime; IQR, in e qua ile ange; LLP, lipid laye pa e n; LWE, lid wipe epi heliopa hy; MBI,
maximum blink in e al; SD, s anda d de ia ion; TMH, ea meniscus heigh .
aUnpai ed - es .
bMann–Whi ney U es .
cFishe 's exac es .
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NEOPHYTE RESPONSE TO DAILY SIHI CL AFTER ONE MONTH
o he pa ame e showed signi ican di e ences be ween
he wo sessions in he expe imen al g oup (Wilcoxon es ,
o pai ed - es , all ≥0.25).
DISCUSSION
The use o CLs is highly p e alen , wi h a a ie y o ma e i-
als and eplacemen op ions being a ailable. CL p ac i ion-
e s a e always ying o p esc ibe he bes solu ion based
on he pa ien 's isual demands and li es yle.33 The choice
o CL ma e ial may signi ican ly impac he i ing p ocess
and po en ially in luence he wea e 's com o .14,34 E en
hough new ma e ials a e a ailable o p ac i ione s p om-
ising ew CL- ela ed complica ions, p olonged CL wea
is leading o an inc easing numbe o pa ien s wi h com-
plain s o lens- ela ed discom o . This is why p ac i ion-
e s widely p esc ibe daily disposable CL, which inc eases
ocula com o h oughou he day and educe possible
CLD associa ed wi h lens ca e sys ems.35,36 The p esen
andomised clinical ial con ibu es aluable in o ma ion
by ocusing on a speci ic daily disposable CL ma e ial (so-
mo ilcon A) and i s impac on ocula symp oma ology and
he al e a ion o he ocula su ace and ea ilm.
All he pa icipan s included in he expe imen al g oup
we e i ed wi h he same daily disposable CL, showing
signi ican di e ences compa ed wi h he con ol g oup
in DEQ- 5, FBUT and LWE (Table2) a e 1 mon h o CL use.
The ini ial discom o expe ienced by i s - ime CL wea -
e s is o en a ibu ed o he sensa ion o he lens edges.
Daily disposable CLs a e o en ound o ha e poo ly in-
ished edges.3,37 This may be because he manu ac u ing
p ocess o daily disposable lenses di e s signi ican ly
om ha o mon hly disposable CL. Daily disposable
CLs a e gene ally moulded, whe eas mon hly dispos-
able CLs a e p oduced using a la he cu ing me hod. This
TABLE 2 Desc ip i e s a is ics and analysis o di e ences be ween he expe imen al and con ol g oups a he baseline session.
Expe imen al g oup Con ol g oup
pn Mean ± SD o median (IQR) nMean ± SD o median (IQR)
DEQ- 5 24 2 (0–5) 20 4 (0.50–7.75) 0.24b
Osmola i y (mOsm/L) 24 316.29 ± 12.59 20 310.20 ± 9.84 0.09a
TMH (mm) 24 0.14 ± 0.04 19 0.12 ± 0.03 0.09a
LLP (Guillon scheme) 24 2 (2–2) 20 2 (2–2) 0.97c
FBUT (s) 24 8.59 (5.33–12.58) 19 12.33 (5.33–15.67) 0.26b
MBI (s) 24 13.33 (10.75–21.12) 19 15.33 (11.33–18) 0.58b
Co neal s aining (Ox o d scheme) 21 0 (0–1) 18 0 (0–0.25) 0.22c
LWE g ade (Ko b Scheme) 24 0 (0–0) 20 0 (0–0) 0.09c
Abb e ia ions: DEQ- 5, D y Eye Ques ionnai e 5; FBUT, luo escein b eak- up ime; IQR, in e qua ile ange; LLP, lipid laye pa e n; LWE, lid wipe epi heliopa hy; MBI,
maximum blink in e al; SD, s anda d de ia ion; TMH, ea meniscus heigh .
aUnpai ed - es .
bMann–Whi ney U es .
cFishe 's exac es .
TABLE 3 Desc ip i e s a is ics and analysis o di e ences be ween he expe imen al and con ol g oups a he 1- mon h session.
Expe imen al g oup Con ol g oup
pn Mean ± SD o median (IQR) nMean ± SD o median (IQR)
DEQ- 5 24 4.50 (3–6) 20 2 (0–6) 0.02*,b
Osmola i y (mOsm/L) 24 313.04 ± 10.97 20 309.35 ± 14.25 0.34a
TMH (mm) 24 0.12 ± 0.04 19 0.11 ± 0.02 0.45a
LLP (Guillon scheme) 23 2 (2–3) 19 2 (2–3) 0.98c
FBUT (s) 24 5.67 (3.84–7.25) 17 9.67 (6.67–22) 0.003*,b
MBI (s) 24 11.34 (10.08–16.25) 17 14.67 (10.67–31.33) 0.12b
Co neal s aining (Ox o d scheme) 23 0 (0–1) 17 0 (0–1) >0.99c
LWE g ade (Ko b Scheme) 11 3 (2–3) 18 0 (0–1) <0.001*,c
Abb e ia ions: DEQ- 5, D y Eye Ques ionnai e 5; FBUT, luo escein b eak- up ime; IQR, in e qua ile ange; LLP, lipid laye pa e n; LWE, lid wipe epi heliopa hy; MBI,
maximum blink in e al; SD, s anda d de ia ion; TMH, ea meniscus heigh .
*Bold alues indica e signi icance se o p ≤ 0.05 o all es s.
aUnpai ed - es .
bMann–Whi ney U es .
cFishe 's exac es .
14751313, 2024, 5, Downloaded om h ps://onlinelib a y.wiley.com/doi/10.1111/opo.13328 by Conso cio In e uni e si a io D, Wiley Online Lib a y on [02/10/2024]. See he Te ms and Condi ions (h ps://onlinelib a y.wiley.com/ e ms-and-condi ions) on Wiley Online Lib a y o ules o use; OA a icles a e go e ned by he applicable C ea i e Commons License
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881
GARCIA- QUEIRUGA e al.
may ha e been e lec ed in he DEQ- 5 and CLDEQ- 8 al-
ues ob ained a he 1- mon h session, whe e new wea -
e s could ha e misin e p e ed he sensa ion o he lens
edges as ocula discom o and d yness. Al e na i ely,
lens edge sensa ion as well as ocula discom o and d y-
ness may ac ually be aking place.17,38 In o de o make
a mo e accu a e asse ion, i would ha e been use ul o
measu e ocula com o immedia ely a e CL inse ion,
o al e na i ely once a week o e he i s mon h o de-
e mine whe he adap a ion occu ed ollowing he ini-
ial discom o .3,36,39 Al hough Pena- Ve deal e al.14 did
no ind di e ences in ocula com o assessed by he
CLDEQ- 8 ques ionnai e in subjec s i ed wi h somo il-
con A and oma ilcon A CL o 1 week, hey pe o med an
in e session analysis and obse ed a educ ion in ocula
com o a e CL wea wi h bo h lens ma e ials, simila o
he cu en indings.
The use o CL is known o dis up no mal ea ilm unc-
ion by al e ing he laye s o he ea ilm and gene a ing
a p e- and pos - lens ea ilm.40 The in e ac ion o he CL
wi h he ocula su ace diminishes he s abili y o he ea
ilm o e he co nea o he CL.41 Despi e he ac ha FBUT
and non- in asi e ea b eak- up ime (NIBUT) a e bo h ech-
niques o measu e he s abili y o he ea ilm, and hei al-
ues a e no in e changeable, a educ ion in bo h pa ame e s
has been ound a e CL use.16,41 Addi ionally, he dis up ion
o he ea ilm laye s did no seem o a ec he lipid laye
hickness, ega dless o he wea ing ime o CL ma e ial, as
epo ed in bo h he p esen s udy and p e ious in es i-
ga ions.16 A newly de eloped con ac lens ma e ial ( e o-
ilcon A), composed o a co e o silicone- hyd ogel ma e ial
ha ing a wa e con en o 33% and an ou e su ace wi h
an 80% wa e con en , showed good p e- CL NIBUT alues
du ing lens wea , when compa ed wi h o he daily dispos-
able silicone- hyd ogel and hyd ogel CLs.42–44 The indings
sugges ha less dehyd a ion may occu on his lens su ace
han on o he ma e ials. Un o una ely, he e a e no epo s
o FBUT o NIBUT a e his ype o CL is emo ed.
Many au ho s ha e indica ed ha ocula complain s
and CLD could be ela ed o he ic ion o he eyelids
o e he CL su ace du ing blinking.13,17,35,38 LWE is an in-
di ec measu e as i is caused by he ic ion, al hough i s
p esence has been associa ed wi h ocula discom o . The
use o ewe ing d ops ha p o ide lub ica ion du ing CL
wea diminishes LWE se e i y o di e en ypes o CLs.45
Howe e , S ahl and Jalbe 17 epo ed no ela ionship be-
ween LWE se e i y and osmola i y alues. In he p esen
indings, pa icipan s in he expe imen al g oup showed
highe alues o LWE bu no signi ican di e ences in os-
mola i y compa ed wi h he con ol g oup. While E on
e al.13 also did no es ablish a de ini i e ela ionship be-
ween CL wea and LWE, hey encou aged in es iga o s
o conduc well- designed s udies o add ess he po en ial
limi a ions o p e ious in es iga ions. Wi h ega d o he
physical p ope ies o he CLs, se e al in es iga o s ha e
associa ed he p esence o LWE wi h he modulus o he CL
ma e ial and he edge p o ile, since bo h ac o s al e he
in e ac ion be ween he CL su ace and he eyelids du ing
blinking.46–48 On he o he hand, he wa e con en o he
CL may play a ole in LWE, as dehyd a ion o he CL will
lead o g ea e ic ion, and lowe alues o LWE a e ound
in silicone- hyd ogel CL wea e s.45 While Mo gan e al.46
s a ed ha no s udies ha e clea ly linked he coe icien o
ic ion wi h LWE, he cu en indings could suppo he
p oposal ha he p esence o LWE is due o he modulus
o he CL ma e ial and edge p o ile a he han he wa e
con en , since silicone- hyd ogel ma e ials exhibi less de-
hyd a ion du ing CL wea .45
The main s eng h o he p esen s udy is ha a con-
ol g oup was examined a he same ime and du ing he
same sessions as he expe imen al g oup. Bo h g oups
we e andomly assigned om a pool o CL neophy es.
Fu he , we ollowed he TFOS ecommenda ions o CL
esea ch.49 All measu emen s we e eco ded by a second
masked obse e who was unawa e o whe he he images
we e om he expe imen al o con ol g oup, hus educ-
ing po en ial bias. Fu he mo e, al hough i may appea as
a limi a ion o ha e used only one ype o CL, his also en-
hances he esul s, as i elimina es ac o s ela ed o he use
o di e en ma e ials, as well as he main enance p oduc s
equi ed o mon hly CLs, whose physical p ope ies could
ha e in luenced he ou comes.50 All hese aspec s ein-
o ce he link be ween CL wea and he p esence o LWE.
Fu he , by using new, daily disposable CL, he possibili y
o deposi s a ec ing he lens su ace was minimised.51,52
In addi ion, he p esen s udy e alua ed symp oms using
s anda dised ques ionnai es, while he signs o ocula su -
ace changes ela ed o CL wea we e assessed ollowing
he TFOS ecommenda ions.6–8
This s udy does ha e some limi a ions. Fi s , i could
ha e been pe o med using daily disposable CLs com-
posed o di e en ma e ials o in es iga e whe he LWE
can be a ibu ed o ma e ial ac o s such as wa e con-
en , modulus, edge p o ile o su ace ea men s o en-
hance CL com o , because o da e he o igins o LWE
a e unclea . While he esul s ob ained he e p o ide
aluable in o ma ion ega ding he sho - e m e ec s o
daily disposable silicone- hyd ogel CL on he ocula su -
ace, i would be o in e es o add a second expe imen-
al g oup wea ing daily o mon hly disposable hyd ogel
CL. In addi ion, despi e a oiding ch onic exposu e o lens
ca e solu ions by using daily disposable lenses, wea e s
we e s ill exposed o lens packaging solu ions.53 Second,
as LWE could be mul i ac o ial, i could be use ul o pe -
o m he s udy on a mo e he e ogeneous sample, includ-
ing subjec s wi h a b oade ange o aces and di e en
ages. Thi d, while he sample inco po a ed s ic inclu-
sion c i e ia, he he e ogenei y o he demog aphics and
ocula cha ac e is ics (e.g., no as igma ism, only young
Caucasians) may also gene a e a lack o di e si y ha lim-
i s he applicabili y o he esul s o o he popula ions,
including olde indi iduals o hose o di e en e hnic
backg ounds. Finally, i should be no ed ha he longi-
udinal du a ion o he cu en in es iga ion was only
14751313, 2024, 5, Downloaded om h ps://onlinelib a y.wiley.com/doi/10.1111/opo.13328 by Conso cio In e uni e si a io D, Wiley Online Lib a y on [02/10/2024]. See he Te ms and Condi ions (h ps://onlinelib a y.wiley.com/ e ms-and-condi ions) on Wiley Online Lib a y o ules o use; OA a icles a e go e ned by he applicable C ea i e Commons License
882
|
NEOPHYTE RESPONSE TO DAILY SIHI CL AFTER ONE MONTH
1 mon h, hus showing only sho - e m e ec s; a longe
ollow- up pe iod could add aluable in o ma ion on he
ocula su ace s a us o hese new CL wea e s.
In conclusion, he p esence o LWE was co ela ed wi h
g ea e symp oma ology on he DEQ- 5 ques ionnai e.
Addi ionally, pa icipan s in he expe imen al g oup exhib-
i ed g ea e LWE a e 1 mon h o CL wea , compa ed wi h
he con ol g oup.
AUTHOR CONTRIBUTIONS
Jacobo Ga cia- Quei uga: Concep ualiza ion (equal);
da a cu a ion (equal); o mal analysis (equal); in es iga ion
(equal); me hodology (equal); isualiza ion (lead); w i -
ing – o iginal d a (equal); w i ing – e iew and edi ing
(equal). Hugo Pena- Ve deal: Concep ualiza ion (equal);
da a cu a ion (equal); o mal analysis (equal); in es iga ion
(equal); me hodology (equal); isualiza ion (equal); w i ing
– o iginal d a (equal); w i ing – e iew and edi ing (equal).
Dolo es Fe ei o- Figuei as: Da a cu a ion (equal); o mal
analysis (equal); in es iga ion (equal); w i ing – o iginal
d a (equal); w i ing – e iew and edi ing (equal). Ve onica
Noya- Padin: Fo mal analysis (equal); isualiza ion (suppo -
ing); w i ing – o iginal d a (equal); w i ing – e iew and ed-
i ing (equal). Ma ia J. Gi aldez: Concep ualiza ion (equal);
me hodology (equal); p ojec adminis a ion (equal); e-
sou ces (equal); supe ision (equal); w i ing – o iginal d a
(suppo ing); w i ing – e iew and edi ing (suppo ing). E a
Yeb a- Pimen el: Concep ualiza ion (equal); me hodology
(equal); p ojec adminis a ion (equal); esou ces (equal);
supe ision (equal); w i ing – o iginal d a (suppo ing);
w i ing – e iew and edi ing (suppo ing).
CONFLICT OF INTEREST STATEMENT
The au ho s decla e ha hey ha e no con lic o in e es in
he p esen s udy and ha hey ecei ed no speci ic und-
ing o his s udy.
ORCID
Jacobo Ga cia- Quei uga h ps://o cid.
o g/0000-0001-7216-4512
Hugo Pena- Ve deal h ps://o cid.
o g/0000-0001-5103-1374
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