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Intrastromal Corneal Ring Segment in Moderate to Severe Keratoconus: Refractive, Topographic and Aberrometric Changes

González Pérez, Javier; García Queiruga, Jacobo; Touriño Peralba, Rosario; Martínez Pérez, Laura; Rodríguez Ares, María Teresa

Abstract

Aim: This study evaluates the topographic and aberrometric changes induced by ICRS in patients with moderate and severe keratoconus and analyzes pre-operative factors affecting the refractive and visual outcomes. Methods: This retrospective, observational, nonrandomized, and single-center case series, included 21 keratoconic eyes of 21 patients implanted with Keraring ICRS (Mediphacos, Belo Horizonte, Brazil), using the manual tunnelization technique and vacuum device. All subjects were examined after 6 months following surgery, including the measurement of uncorrected visual acuity (UCVA), best-Corrected Distance Visual Acuity (CDVA), refractive data, pachymetry, corneal topography, and aberrometry. Results: The mean age of 21 patients was 31.14±10.65 years, eleven (52%) were male. Kerarings were successfully implanted in all eyes. After 6-month from implantation, significant increase was found in mean UCVA (P<0.01) and CDVA (P<0.01). There was a statistically significant reduction in refractive cylinder (P<0.01), corneal cylinder (P=0.020), Kmax (P<0.01) and BFS (P=0.02). Statistically significant differences were found in several aberrometric parameters for 6-mm pupil, RMS HOA (P=0.045), oblique astigmatism (P=0.009), vertical coma (P=0.02), and oblique trefoil (P=0.018). Conclusion: Analysis of the visual outcomes after Keraring ICRS implantation showed a significant postoperative corneal flattening with a subsequent increase in UCVA and CDVA. Visual, refractive, topographic and aberrometric parameters remarkably change in the 6-month period after Kerarings implantation. Kerarings in this sample have shown to provide a mild visual rehabilitation between 2 and 3 lines, particularly in more advanced cases. Furthermore, flattening of the anterior segment induced by the surgery might be beneficial for contact lens fitting.

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In as omal Co neal Ring Segmen in Mode a e o Se e e Ke a oconus: Re ac i e, Topog aphic and Abe ome ic Changes Ja ie González-Pé ez1*, Jacobo Ga cía Quei uga1, Rosa io Tou iño Pe alba2, Lau a Ma ínez-Pé ez2 and Mª Te esa Rod íguez A es2,3 1Depa men o Applied Physics (Op ome y), Uni e si y o San iago de Compos ela, Spain 2Oph halmology Se ice, Uni e si y Hospi al Complex o San iago de Compos ela, Spain 3Depa men o Su ge y (Oph halmology), Uni e si y o San iago de Compos ela, Spain In oduc ion Ke a oconus (KC) is a common, p og essi e co neal disease esul ing in ch onic hinning and p o usion o he pa a-cen al co nea associa ed wi h myopia, i egula as igma ism and high o de abe a ion inc ease [1]. The ea men di e s depending on he s age o he diso de . Visual acui y can be imp o ed wi h spec acles in he ea ly s age o his condi ion o wea ing con ac lenses also e ec i e o p o ide a good ision in mode a e KC [2]. When an op ical co ec ion is no longe e ec i e, o no con ac lenses a e well ole a ed, se e al su gical ea men s a e used o he ea men o KC, including In aco neal Co neal Ring Segmen s (ICRS) and co neal collagen c oss-linking (CXL) [3,4]. Howe e , KC may e en ually equi e co neal g a ing as hei se e e condi ion p og esses, ep esen ing he mos common indica ion o ke a oplas y in he de eloped wo ld [4]. Nowadays, he e is a g owing in e es in ea men op ions ha may delay o de e co neal g a ing, including ICRS implan a ion, o iginally used o co ec mode a e- o-se e e myopia, by exe ion o a e-modelling e ec C imson Publishe s Wings o he Resea ch Resea ch A icle *Co esponding au ho : Ja ie González- Pé ez, Depa men o Applied Physics (Op ome y), Uni e si y o San iago de Compos ela, Spain Submission: No embe 11, 2023 Published: Janua y 29, 2024 Volume 3 - Issue 3 How o ci e his a icle: Ja ie González- Pé ez*, Jacobo Ga cía Quei uga, Rosa io Tou iño Pe alba, Lau a Ma ínez- Pé ez and Mª Te esa Rod íguez A es. In as omal Co neal Ring Segmen in Mode a e o Se e e Ke a oconus: Re ac i e, Topog aphic and Abe ome ic Changes. Med Su g Oph hal Res. 3(3). MSOR. 000565. 2024. DOI: 10.31031/MSOR.2024.03.000565 Copy igh @ Ja ie González-Pé ez, This a icle is dis ibu ed unde he e ms o he C ea i e Commons A ibu ion 4.0 In e na ional License, which pe mi s un es ic ed use and edis ibu ion p o ided ha he o iginal au ho and sou ce a e c edi ed. ISSN : 2578-0360 1 Medical & Su gical Oph halmology Resea ch Abs ac Aim: This s udy e alua es he opog aphic and abe ome ic changes induced by ICRS in pa ien s wi h mode a e and se e e ke a oconus and analyzes p e-ope a i e ac o s a ec ing he e ac i e and isual ou comes. Me hods: This e ospec i e, obse a ional, non andomized, and single-cen e case se ies, included 21 ke a oconic eyes o 21 pa ien s implan ed wi h Ke a ing ICRS (Mediphacos, Belo Ho izon e, B azil), using he manual unneliza ion echnique and acuum de ice. All subjec s we e examined a e 6 mon hs ollowing su ge y, including he measu emen o unco ec ed isual acui y (UCVA), bes -Co ec ed Dis ance Visual Acui y (CDVA), e ac i e da a, pachyme y, co neal opog aphy, and abe ome y. Resul s: The mean age o 21 pa ien s was 31.14±10.65 yea s, ele en (52%) we e male. Ke a ings we e success ully implan ed in all eyes. A e 6-mon h om implan a ion, signi ican inc ease was ound in mean UCVA (P<0.01) and CDVA (P<0.01). The e was a s a is ically signi ican educ ion in e ac i e cylinde (P<0.01), co neal cylinde (P=0.020), Kmax (P<0.01) and BFS (P=0.02). S a is ically signi ican di e ences we e ound in se e al abe ome ic pa ame e s o 6-mm pupil, RMS HOA (P=0.045), oblique as igma ism (P=0.009), e ical coma (P=0.02), and oblique e oil (P=0.018). Conclusion: Analysis o he isual ou comes a e Ke a ing ICRS implan a ion showed a signi ican pos ope a i e co neal la ening wi h a subsequen inc ease in UCVA and CDVA. Visual, e ac i e, opog aphic and abe ome ic pa ame e s ema kably change in he 6-mon h pe iod a e Ke a ings implan a ion. Ke a ings in his sample ha e shown o p o ide a mild isual ehabili a ion be ween 2 and 3 lines, pa icula ly in mo e ad anced cases. Fu he mo e, la ening o he an e io segmen induced by he su ge y migh be bene icial o con ac lens i ing. Keywo ds: Ke a oconus; In as omal co neal ing segmen s; Ke a ing; Vacuum sys em; K as igma ism; Sphe ical abe a ion; Coma; Co neal hickness 2 Med Su g Oph hal Res Copy igh © Ja ie González-Pé ez MSOR.000565. 3(3).2024 on he co neal s oma [5-7]. The implan a ion means he addi ion o ex a ma e ial a he mid-pe iphe al co nea and subsequen ly educing s eepening o he cen al a ea. This e-modelling is in ended o dec ease e ac i e e o magni ude, imp o e cen al co neal su ace egula i y and, mo eo e , o inc ease co neal s abili y and delay he p og ession o KC [8]. I has been epo ed ha changes in he co neal s oma induced by ICRS a e di ec ly p opo ional o he hickness and in e sely p opo ional o i s diame e and dep h o implan a ion [9,10]. The e a e se e al comme cially a ailable ICRS ha di e in hei sec ion shape, diame e , a c leng h, hickness, and zone o implan a ion. The Ke a ing ICRS (Mediphacos, Belo Ho izon e, B azil), is a small, a c-like segmen made o polyme hyl me hac yla e cha ac e ized by a 5 o 6mm diame e and unique p isma ic design a ailable in di e en a c leng hs (90º, 120º,160º,210º and 355º), wi h a iable hickness anging om 150 o 350mm (in 50mm inc emen s). In he las 10 yea s, se e al clinical s udies ha e a emp ed o demons a e hei e icacy o imp o e isual unc ion, educing he magni ude o co neal as igma ism, and la ening he cen al co nea [11-14]. I has been p oposed ha he p eope a i e mani es e ac ion o bes co ec ed isual acui y a e p edic i e ac o s wi h a limi ed abili y o p edic he pos ope a i e isual ou come, while abe ome y has been ound o ha e a be e p edic i e po en ial [15]. The assessmen o isual and mo phological ea u es should p o ide aluable insigh s in o he de e minan s o he co ela ion be ween co neal su ace p ope ies and he imp o emen o isual acui y ollowing ICRS su ge y. Al hough his subjec has al eady been s udied, he e is s ill a lack o publica ions conce ning he mo phome ic and isual ou comes a e Ke a ing ICRS implan a ion using he manual echnique, especially in he ecen pe iod. Despi e new app oaches using he inc easingly equen em osecond echniques, hose a e no a ailable o many su geons a ound he wo ld. In addi ion, he e is s ill a lack o in o ma ion conce ning he ou comes on se e e ke a oconus pa ien s. The aim o his s udy was o con ibu e o de e mine how ICRS su ge y a ec o mo phome ic co neal pa ame e s and iden i y ac o s a ec ing he opog aphic and isual ou comes ollowing Ke a ing ICRS implan a ion in a no h- wes o Spain sample. Subjec s and Me hods To e alua e he impac and implica ions o ICRS implan a ion on he co neal su ace, we conduc ed a e ospec i e, obse a ional, non andomized, and single-cen e case se ies o pa ien s implan ed wi h Ke a ing segmen s (Mediphacos, Belo Ho izon e, B azil) using he manual echnique. Sample and inclusion c i e ia The s udy was conduc ed a he An e io Segmen Uni om Hospi al de Conxo-Complejo Hospi ala io de San iago de Compos ela (A Co uña, Spain), and comp ises a o al o 21 mode a e and se e e KC subjec s acco ding o he Amsle -K umeich classi ica ion, aged 31.14±10.65 yea s. The s udy p o ocol was app o ed by he E hic and Scien i ic Commi ees o he Uni e si y o San iago de Compos ela (Spain) and ollowed he ene s o he Decla a ion o Helsinki. Eligibili y c i e ia included KC subjec s, 18 yea s o age o olde , showing educed spec acle/con ac lens bes co ec ed dis ance isual acui y o con ac lens in ole ance and maximum co neal powe (Kmax) be ween 49 o 70 D. Diagnosis and g ading o he disease was based on co neal opog aphy and sli lamp examina ion. Ocula assessmen All pa ien s unde wen a comple e p eope a i e examina ion, including ou ine e alua ion o Snellen Unco ec ed Dis ance Visual Acui y (UDVA), Snellen Bes -Co ec ed Dis ance Visual Acui y (CDVA), e ac i e e o , undus examina ion, sli lamp biomic oscopy, co neal opog aphy and pachime y wi h pa icula a en ion o he occu ence o ocula ad e se e en s. Topog aphic analysis was pe o med using Pen acam (Oculus GmbH, We zla , Ge many), which include 3mm-a ea ke a ome ic eadings, co neal as igma ism, kmax, eccen ici y, co neal hickness (minimum, apex and cen al), and se e al abe ome ic pa ame e s. The same p o ocol was applied p eope a i e and 6-mon hs a e ICRS implan a ion. Su ge y and pos ope a i e p ocedu es All su ge ies we e pe o med by he same su geon unde s e ile condi ions wi h opical anes hesia 0.5% p opa acaine hyd ochlo ide solu ion (Alcaine, Alcon). The app op ia e Ke a ing segmen s diame e (6-mm diame e ), hickness and leng h (deg ees) we e selec ed in acco dance wi h nomog am p oposed by he manu ac u es, and hen implan ed in o he eye. The incisions we e always made in he s eepes co neal me idian. Co neal unneliza ion o ing segmen inse ion was pe o med by mechanical echnique dissec ion and a Ke a ing acuum de ice (Mediphacos, Belo Ho izon e, B azil) was employed o s abilize he globe and o keep he plane o dissec ion o he unnel by suc ion. A e ma king he geome ical cen e o he co nea, a 1.2mm adial incision was pe o med using a calib a ed diamond blade (Sinskey hook), a he dep h o 80% co neal hickness a he s eepes me idian. An in as omal pocke was c ea ed using a small incision wi h a semici cula mic o-dissec o ha ope a es unde suc ion, un il inishing he unnels in he desi ed di ec ions (clockwise and coun e clockwise dissec ion) and 6mm in diame e . Once his s ep was comple ed, he su geon emo es he suc ion and he Ke a ing implan was placed in o he pocke using implan a ion o ceps. The pocke was sel -sealing and did no equi e su u ing. Subsequen ly, a Pu eVision silicone hyd ogel bandage con ac lens (Bausch & Lomb) was placed on he co nea and hen emo ed 1 day a e he su ge y. No in aope a i e complica ions occu ed. Pos ope a i e ea men comp ised be ame hasone d ops ou imes a day, opical ob amycin 0.3% (Tob ex, Alcon) ou imes a day, and p ese a i e- ee a i icial ea s (A elac Rebalance, Bausch & Lomb, Inc., No h B idgewa e , NJ, USA) six imes a day. The ob amycin d ops we e discon inued 1 week a e he su ge y, while he be ame hasone dosage was ape ed o e a pe iod o 4 o 6 weeks. Da a Analysis The Shapi o-Wilk no mali y es was implemen ed o assess all da a se s o no mal dis ibu ion. The ca ego ical a iables (sex and 3 Med Su g Oph hal Res Copy igh © Ja ie González-Pé ez MSOR.000565. 3(3).2024 numbe o igh and le eyes) a e exp essed as equencies. The con inuous a iables (age and he p e- and pos ope a i e UDVA, CDVA, sphe e, cylinde , sphe ical equi alen , K1, K2, Kmean, Kmax, co neal pachome y and abe ome ic measu emen s) a e exp essed as means wi h S anda d De ia ions (SD) o easie compa isons and in e p e a ion wi h he exis ing li e a u e. The di e ences be ween he p eope a i e and pos ope a i e measu emen s we e compa ed using pai ed - es s when pa ame ic s a is ical analysis was possible, and he Wilcoxon Signed anks es o non-pa ame ic e alua ion. Pea son o Spea man co ela ion coe icien s we e used o e alua e co ela ion be ween di e en a iables, depending on whe he no mal dis ibu ions o da a we e obse ed. Fo s a is ical pu poses, P alue less han 0.05 was conside ed s a is ically signi ican . SPSS .24.0.0.0 (IBM Co po a ion, A monk NY) and Excel .15.0 (Mic oso Co po a ion, Redmond WA) so wa e we e used o all s a is ical analysis and g aphs. Resul s Visual and e ac i e pa ame e s A summa y o he isual and e ac i e changes in eyes implan ed wi h ke a ing segmen s a e shown in Table 1. Bo h, mean UDVA and CDVA we e signi ican ly inc eased ollowing 6-mon hs a e ICRS implan a ion. Mean p eope a i e sphe e, co neal cylinde and mani es sphe ical equi alen we e signi ican ly dec eased a 6-mon hs a e su ge y. Howe e , when ec o decomposi ion o e ac ion was pe o med J0 and J45 ec o s changes we e no s a is ically signi ican . Table 1: Re ac i e changes da a be o e and 6-mon hs a e su ge y. UDVA (unco ec ed dis ance isual acui y); CDVA (co ec ed dis ance isual acui y); MRSE (mani es e ac i e sphe ical equi alen ); J0 (Humph ey ec o c oss cylinde compound ixed a 0º/90º); J45 (Humph ey ec o c oss cylinde compound ixed a 45º/135º); D (diop e) aPai ed samples - es ; bWilcoxon signed ank es Va iable P eope a i e Pos ope a i e Change P UDVA (Snellen) 0.12±0.15 0.35±0.19 0.23±0.09 <0.001b CDVA (Snellen) 0.47±0.21 0.68±0.17 0.21±0.18 0.005a Sphe e (D) -3.43±2.21 -2.27±2.55 1.16±2.36 0.023b Cylinde (D) -5.42±1.94 -2.08±1.48 3.33±1.53 0.002a MRSE (D) -5.14±2.69 -3.32±2.50 1.82±2.58 0.004a J0 (D) 0.18±1.97 -0.07±1.07 -0.24±2.01 0.584a J45 (D) -0.02±2.17 -0.10±0.73 -0.08±2.05 0.867a Topog aphic pa ame e s and pos ope a i e ou comes Table 2 summa izes opog aphic and pachome ic da a p eope a i e and 6-mon hs a e Ke a ings implan a ion. As shown in Figu e 1, he Ke a ings la ening e ec was mo e e iden in he s eepes 3-mm a ea (P=0.05) when compa ed wi h he mean 3-mm ke a ome y eadings wi h a 1.94 D dec ease e ec on he an e io co neal as igma ism (P<0.001). The s onge la ening e ec was obse ed on he maximum ke a ome y eadings when compa ed p e- and pos ope a i e alues (P<0.001). A simila end was obse ed in he adius o an e io Bes Fi Sphe e (BFS) p eope a i e and 6-mon h a e su ge y (P=0.020). Mean Cen al Co neal Thickness (CCT) showed a sligh ly highe inc ease (2.0%), al hough non-clinically signi ican a e 6-mon hs o ICRS implan . A simila end was obse ed o apex (P=0.186) and minimum co neal hickness (P=0.067). As expec ed, signi ican co ela ions we e ound be ween pos ope a i e ou comes and p eope a i e opog aphic co neal pa ame e s, as well as segmen pa ame e s (Table 3). Using he nomog ams o ICRS implan a ion ecommended by he manu ac u e, we ound a mode a e co ela ion be ween he hicke Ke a ing segmen s and changes in mani es cylinde ( =0.491; P=0.023) and changes in BFS ( =0.440; P=0.046). Table 2: Summa y o he opog aphic and pachome ic da a a e 6-mon hs Ke a ing implan a ion. K1 (co neal powe in he la es 3-mm a ea); K2 (co neal powe in he s eepes 3-mm a ea); k2-k1 (mean co neal as igma ism in he 3-mm a ea); Km (mean co neal powe in he 3-mm a ea); Kmax (maximum co neal powe in he 8-mm a ea); BFS (bes - i sphe e); CCT (cen al co neal hickness); D (diop e); µm (mic ons) aPai ed samples - es ; bWilcoxon signed ank es Va iable Mean±SD P P eope a i e Pos ope a i e Change K1 (D) 46.02±3.47 46.01±3.15 -0.01±2.18 0.992a K2 (D) 51.34±4.55 49.41±3.25 -1.93±3.39 0.050b K2-K1 (D) 05.32±2.37 03.38±2.41 -1.94±3.50 0.020a Km (D) 48.49±3.70 47.71±2.97 -0.78±1.98 0.095a Kmax (D) 57.40±6.44 51.97±4.01 -5.43±5.16 <0.001a 4 Med Su g Oph hal Res Copy igh © Ja ie González-Pé ez MSOR.000565. 3(3).2024 An e io BFS (D) 43.55±3.05 42.40±2.24 -1.05±2.56 0.020b Eccen ici y 0.88±0.32 0.75±0.33 -0.13±0.36 0.079b CCT (mm) 478±39 487±58 9.10±49.73 0.412a CTapex (mm) 462±41 478±62 15.95±53.41 0.186a CTmin (mm) 448±40 461±47 12.90±30.57 0.067a Figu e 1: Humph ey ec o cylinde compound o he e ac ion showing a ema kable less dispe sion o pos ope a i e alues. Table 3: S a is ically signi ican co ela ions o he 6-mon h pos ope a i e ou comes wi h p eope a i e opog aphic, abe ome ic and Ke a ing segmen pa ame e s. UDVA (unco ec ed dis ance isual acui y); CDVA (co ec ed dis ance isual acui y); MRSE (mani es e ac i e sphe ical equi alen ); TKS ( hicke Ke a ing segmen ); K2 (co neal powe in he s eepes 3-mm a ea); K2-K1 (mean co neal as igma ism in he 3-mm a ea); Km (mean co neal powe in he 3-mm a ea); Kmax (maximum co neal powe in he 8-mm a ea); BFS (bes - i sphe e); CA (co neal as igma ism); RMS ( oo mean squa e); HOA (highe o de abe a ion); D (diop e); µm (mic ons); Ze nike e ms (Zo de mode) aPea son co ela ion; bRho Spea man Va iable Co ela iona,b Co ela ion Coe icien P Change in CDVA (Snellen) P eop K2 0.51 0.018a P eop Km 0.507 0.019a P eop Kmax 0.502 0.021a P eop CTapex -0.641 0.002a P eop CTmin -0.65 0.001a P eop P ima y Ve ical CA Z2 2-0.78 <0.001a P eop 4 h-o de sphe ical abe a ion Z4 0-0.54 0.011a Change in mani es Cylinde (D) P eop Cylinde -0.657 0.001a P eop MRSE -0.437 0.047a P eop K2 0.482 0.027a P eop kmax 0.582 0.006a P eop P ima y Oblique CA Z2 -2 -0.444 0.044a P eop Ho izon al Coma Z2 2-0.574 0.006a TKS 0.491 0.023a 5 Med Su g Oph hal Res Copy igh © Ja ie González-Pé ez MSOR.000565. 3(3).2024 Change in MRSE (D) P eop Sphe e -0.612 0.003b P eop Cylinde -0.475 0.029b P eop MRSE -0.668 0.001b P eop Ve ical Coma Z3 -1 -0.622 0.003b Change in Mean Kmax (D) P eop K2 -0.687 0.001a P eop K2-K1 -0.643 0.002a P eop Kmax -0.782 <0.001a P eop Eccen ici y -0.483 0.027a P eop 4 h-o de sphe ical abe a ion Z4 00.574 0.007a Change in Mean K2-K1 (D) P eop K2 -0.545 0.011a P eop K2-K1 -0.498 0.022a P eop Kmax -0.728 <0.001a Change in Mean BFS (D) P eop Kmax -0.634 0.002b P eop 4 h-o de sphe ical abe a ion Z4 00.466 0.033b P eop RMS HOA -0.437 0.048b TKS 0.44 0.046b Change in Ve ical Coma Z3 -1 (mm) P eop P ima y Oblique CA Z2 -2 0.461 0.035a P eop Ve ical Coma Z3 -1 0.871 <0.001a TKS 0.588 0.005a Change in Oblique T e oil (mm) P eop Sphe e -0.636 0.026a P eop MRSE -0.583 0.046a Abe ome ic pa ame e s and pos ope a i e ou comes Table 4 summa izes abe ome ic da a be o e and 6-mon hs a e su ge y. A signi ican dec ease was obse ed in he mean RMS high o de abe a ions alues (P=0.045). The e ical coma, oblique e oil and oblique co neal as igma ism became, on a e age, less posi i e a e su ge y (P=0.020, P=0.018 and P<0.01 espec i ely). No signi ican changes we e obse ed in o al RMS o o he esidual abe a ions. Nega i e signi ican co ela ions we e ound be ween pos ope a i e change in bes CDVA and se e al p eope a i e abe ome ic co neal pa ame e s (Table 3), such as p ima y e ical co neal as igma ism ( =-0.780; P<0.001), and sphe ical abe a ion ( =-0.540; P=0.011). Figu e 2 shows he nega i e ela ionship be ween change CDVA and he signi ican co ela ed abe ome ic ac o s. Simila ly, nega i e co ela ions we e ound be ween MRSE o change in mani es cylinde and di e en p eope a i e abe ome ic co neal pa ame e s. Sca e g ams showing he nega i e ela ionship be ween change in MRSE o mani es cylinde and p eope a i e coma can be seen in Figu e 3. Figu e 2: Sca e g ams showing he ela ionship be ween he change in he bes co ec ed dis ance isual acui y and: A) P eope a i e p ima y e ical co neal as igma ism; B) Sphe ical abe a ion. 6 Med Su g Oph hal Res Copy igh © Ja ie González-Pé ez MSOR.000565. 3(3).2024 Table 4: Summa y o he co neal abe ome ic da a a e 6-mon hs Ke a ing implan a ion. RMS ( oo mean squa e); HOA (highe o de abe a ion); µm (mic ons); Ze nike e ms (Zo de mode) aPai ed samples - es Va iable Mean±SD P P eope a i e Pos ope a i e Change RMS HOA (mm) 5.20±1.92 3.98±2.08 -1.22±2.63 0.045a Ve ical coma Z3 -1 (mm) 3.15±2.50 1.30±1.31 -1.85±1.83 0.020a Ho izon al coma Z3 1 (mm) 4.99±1.91 4.07±2.92 -0.92±1.16 0.111a P ima y sphe ical abe a ion Z4 0 (mm) 1.76±2.00 1.54±1.59 -0.22±1.73 0.657a P ima y Ve ical CA Z2 2 (mm) 4.72±3.81 3.31±4.03 -1.41±1.56 0.171a P ima y Oblique CA Z2 -2 (mm) 3.02±3.12 0.63±2.54 -2.39±1.86 0.009a Oblique T e oil Z3 3 (mm) 0.72±1.28 0.14±1.37 -0.58±0.91 0.018a Figu e 3: Sca e g ams showing he ela ionship be ween: A) The change in mani es e ac i e sphe ical equi alen and p eope a i e e ical coma; B) The change in mani es cylinde and p eope a i e ho izon al coma. Discussion The dec ease in isual quali y in subjec s wi h ke a oconus is no only due o low-o de abe a ions (sphe o-cylind ical e ac i e e o ) esul ing om co neal p o usion bu is also due o high- o de ones. This is p ac ically explained by he ac ha spec acles in mos cases a e no able o p o ide ull co ec ion. This s udy e alua ed he e ec o Ke a ings (mechanical implan a ion wi h a acuum de ice) on isual, e ac i e, opog aphic and abe ome ic ou comes in pa ien s wi h KC and high myopia 6-mon hs a e ICRS su ge y. Visual acui y and e ac i e pa ame e s The cu en s udy showed a signi ican educ ion in mani es sphe e, cylinde and sphe ical equi alen which a e in ag eemen wi h p e ious au ho s [15-20]. Consis en wi h he signi ican educ ion in e ac ion, ou s udy showed a signi ican imp o emen om 2 o 3 lines in UCVA and CDVA, which is consis en wi h o he s udies epo ing g ea e inc ease in UDVA han in CDVA, [16] while o he au ho s ha e obse ed be e esul s in CDVA han UDVA [17]. Fac o s jus i ying hese di e ences could be a ibu ed o a ia ions in he s uc u e and hickness o he segmen s, dis ance om he cen e , as well as o ien a ion and symme y in he inse ion o he ings [18]. In ac , baseline disease se e i y and he pa e n o ec asia a e so he e ogeneous in ke a oconic eyes, ha gene aliza ions a e no possible o may ha e no sense. A signi ican inding in his s udy is ha isual acui y changes ha e been highe o hose pa ien s wi h mo e se e e s ages o he disease. This inding ag ees wi h he cu en app oaches o sequen ial KC ea men ha assumes o he ea men s o ea ly o ms o KC including co neal c oss-linking and con ac lenses, lea ing ICRS when he disease is al eady s able and e en ually mo e ad anced [19]. An imp o emen in UDVA is a ibu able mos ly o a educ ion in lowe o de abe a ions (MRSE, sphe e o cylinde ), while an imp o emen in CDVA is a ibu ed o educ ion in co neal abe a ions (p ima y sphe ical abe a ion, co neal as igma ism, o coma). Topog aphic pa ame e s and pos ope a i e ou comes In he majo i y o s udies, ICRS implan a ion induces a signi ica i e educ ion in Km and Kmax eadings be ween 2 o 5 7 Med Su g Oph hal Res Copy igh © Ja ie González-Pé ez MSOR.000565. 3(3).2024 D, wi h a signi ican as igma ic educ ion be ween 1.5 o 2.75 D, allowing an imp o emen o isual acui y anging o 1 o 7 lines in CDVA [9-10,19-21]. This high a ia ion in isual pe o mance depends on KC s age, cone loca ion, as igma ism cha ac e iza ion and ICRS ype [19-22]. The p esen in es iga ion shows a no signi ican Km educ ion by 0.78 D, bu a signi ican Kmax educ ion by 5.43 D wi h a dec eased co neal as igma ism by close o 2.00 D associa ed wi h as igma ic educ ion by 3.33 D. Associa ed wi h hose changes, in his s udy, we ound an imp o emen o 0.21 Snellen uni s be ween p e-ope a i e and pos -ope a i e UDVA which is in ag eemen wi h mos o he e iewed li e a u e [19- 21]. Howe e , Km change in his s udy seems o be lowe han ha ound by o he au ho s, p obably because we ha e mo e se e e cases, wi h highe p eope a i e co neal as igma ism and poo e p e-ope a i e co ec ed and unco ec ed isual acui y, so he ac o s in ela ion o he cha ac e is ics o he subjec s wi h KC may be behind hese di e ences. The p esen s udy shows ha educ ion o co neal as igma ism is he main ac o jus i ying he imp o emen in isual acui y. This educ ion has been ound in mos o he eyes (19 ou o 21) excep one eye wi hou measu able changes and ano he eye wi h a signi ican inc ease in as igma ism. Reduc ion anged om 0 o 10 D o cylinde . In line wi h a gumen s o di e en indica ions o di e en s ages o KC, he ole o ICRS in co neal s abiliza ion has also been objec o in e es by he oph halmological communi y and has been p oposed ha maximum cu a u e and hinnes co neal hickness migh be used as indica o s o KC s abiliza ion/p og ession [23]. In he p esen s udy, we obse ed a educ ion in Kmax and an inc ease in he co neal hickness pa ame e s. Howe e , as we did only make a single measu emen a e su ge y, he p esen s udy canno e i y he e ec o ICRS in co neal s abili y o e ime due o he ela i ely sho ollow-up pe iod. Se e al s udies in es iga ing he po en ial ole o ICRS in disease s abiliza ion ound ha implan a ion o ICRS does no signi ican ly in luence p og essi e ke a oconus in young pa ien s wi h con i med p og ession o he disease [24-26]. Since o he au ho s ound ICRS implan a ion o be a s able p ocedu e o es o ing ision in pa ien s wi h KC, his ma e should be u he in es iga ed [27]. Finally, because o he la ening induced by his echnique, he e is ano he impo an bene icial ou come. Conside ing he limi ed imp o emen in UDVA and CDVA ob ained by he ICRS implan a ion, con ac lenses a e usually necessa y o complemen he ehabili a ion. This s a egy has p o ed o be success ul in p e ious publica ions, using di e en ma e ials and i ing app oaches [28-29]. The opog aphic indings om his s udy migh be also ele an on his ega d as we ha e ound a educ ion in maximum ke a ome ic eading and educ ion in an e io co neal as igma ism. This migh ha e implica ions in con ac lens i ing a di e en le els. Fi s , he la ening e ec obse ed in he la ening o he s eepes me idian by 1.90 D and by o e 5.50 D in he Kmax pa ame e . This la ening is also obse ed in he BFS pa ame e wi h a educ ion o nea ly 1.00 D. This ep esen s a la ening o he o e all co neal cu a u e ha migh imp o e he i ing o a co neal igid gas pe meable con ac lens. Second, educ ion o an e io co neal as igma ism nea ly 2.00 D migh also imp o e he i ing o he con ac lens as i is usual o ind a s eep i ing along he la es me idian. F om he i ing poin o iew, we hypo hesize ha a educ ion o nea ly 0.20 mm in he s eepes cu a u e, 0.40 mm in co neal as igma ism migh imp o e co neal lens i ing. Howe e , we acknowledge ha he p esence o he ICRS, hickening he mid-pe iphe al co nea, migh also p esen a challenge o he i ing as he loca ion o hese segmen s migh c ea e a mechanical con lic wi h he unde lying co neal issue. Howe e , his migh be o e come using la ge diame e lenses suppo ed by he pe iphe al co nea ou side he 5-6 mm o he ICRS unnel. Abe ome ic pa ame e s and pos ope a i e ou comes When co neal abe a ions we e analyzed, e ical coma, p ima y oblique co neal as igma ism and e oil dec eased 6-mon hs a e su ge y, as he main abe ome ic changes ound in his s udy. In addi ion, we ound a signi ican pos ope a i e RMS HOA a 6 mm imp o emen while no changes we e obse ed in o he esidual abe a ions which suppo s he indings o some au ho s and con adic s o he s [15,20]. The p edominan abe ome ic de ec in KC is he coma abe a ion, pa icula ly i s e ical componen , such is he case ha Alió and Shabayek used his pa ame e o modi y he classic Amsle -K umeich classi ica ion o KC, in oducing coma abe a ion as one o he indica o s [30]. Coma has been ound o be dec eased in he sho - e m and he long- e m pe iods a e ICRS implan a ion [8,17,21]. Since di e en au ho s ha e demons a e ha coma has a nega i e e ec on isual acui y [24], he educ ion in coma abe a ion, especially in e ical coma, migh also explain he imp o emen in CDVA ound in his in es iga ion, which is in ag eemen wi h o he au ho s [20,23,25]. Howe e , he e a e o he s udies epo ing no signi ican changes in any co neal abe ome ic pa ame e a e ICRS implan a ion by mechanical unneliza ion, which is con adic o y o he indings o he p esen s udy [15]. Tha s udy ound ha mechanical unneliza ion speci ically o In acs implan a ion in eyes wi h ea ly o mode a e KC has limi ed he po en ial abe ome ic co ec ion because he p ocedu e i sel gene a ed new abe a ions, pa icula ly nega i e p ima y sphe ical abe a ion, and p ima y coma, bu his end was no speci ically con i med o Ke a ings because he limi a ions o he s udy o his segmen ype. O he ac o s could explain hese di e ences, o example, we may ha e included mo e mode a e and se e e cases and obse ed less complica ions compa ed wi h p e ious s udies. Ano he possible explana ion, as men ioned abo e, could be he cha ac e is ics o he segmen s as well as o ien a ion and symme y in he ICRS inse ion [18,26]. Limi a ions A limi a ion o his s udy is he educed sample size. Howe e , based on ou ini ial es ima ions, he sample was powe ed o obse e a leas 1 line o imp o emen in isual acui y wi h 18 eyes en olled. A u he limi a ion migh be conside ed he ac ha he implan a ion mode has been manual while em osecond lase -assis ed echnology migh be conside ed he e e ence o ICRS implan a ion. In ac , em osecond lase can assis in a be e p edic ion o he dep h and a ea o implan a ion, minimizes p ocedu e du a ion, and educes he isk o in lamma ion, bu 8 Med Su g Oph hal Res Copy igh © Ja ie González-Pé ez MSOR.000565. 3(3).2024 p e ious esea ch has ailed o demons a e supe io i y in isual ou comes when compa ed wi h manual implan a ion [15]. In addi ion, an al e na i e o he manual app oach is o use a acuum de ice, such as he employed in his s udy o s abilize he globe du ing c ea ion o he co neal unnel o ob ain be e isual acui y and mo e con olled co neal shape, howe e mo e esea ch is equi ed in his a ea o e alua e and compa e he clinical ou comes. Fu he mo e, we bea in mind ha s ill nowadays mos o he implan a ions a e made wi h manual echnique including many e ia y e e ence hospi als as is ou case. 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