Short-term tear film stability, optical quality and visual performance in two dual-focus contact lenses for myopia control with different optical designs

1062 | 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 | Accep ed: 20 June 2022 | 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 | 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 | 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) | 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 | 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) | 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 | 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. | 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 | 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.