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

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

Author: González Pérez, Javier; García Queiruga, Jacobo; Touriño Peralba, Rosario; Martínez Pérez, Laura; Rodríguez Ares, María Teresa
Publisher: Crimson Publishers
Year: 2024
DOI: 10.31031/MSOR.2024.03.000565
Source: https://minerva.usc.es/bitstreams/1472e8f4-f22b-4eac-be1c-40f0517a6824/download
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
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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
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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
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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
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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
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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.

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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
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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
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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.
In conclusion, analysis o he ou comes a e Ke a ings
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 ing ICRS implan a ion. Co ela ions
be ween isual ou comes and p eope a i e pa ame e s sugges a
s onge e ec in KC pa ien s wi h highe K2, Km o Kmax alues as
well as highe as igma ism, coma, and sphe ical abe a ion, which
imply pa ien s wi h mo e se e e s ages o he disease.
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