TELAAH KRITIS JURNAL HARM/ETIOLOGY

PENUGASAN BLOK 3.4 MASALAH PADA DEWASA I

Risk Factor for Contact-Lens Related Microbial Keratitis: A Case-Control Multicenter Study

Disusun oleh:

Elvira Rahma Karmeilia (18711107)

Intan Kusumaningtyas (18711162)

Alfia Qurrota Ayun (18711170)

Tutor: dr. Dimas Satya Hendarta

FAKULTAS KEDOKTERAN

UNIVERSITAS ISLAM INDONESIA

YOGYAKARTA

2021
 Deskripsi kasus (No.4 / Topik Mata)

Seorang pasien remaja datang ke dokter untuk berkonsultasi mengenai kontak lensa
yang digunakannya. Pasien membaca bahwa kontak lensa dapat menyebabkan infeksi
pada mata. Apakah hal tersebut benar?

Langkah-langkah telaah jurnal

1. Merumuskan pertanyaan klinis yang dapat dijawab

P
(Populasi dan masalah Remaja pengguna lensa kontak
klinis)
I
Penggunaan kontak lensa
(Intervensi /Indikator)
C
-
(Comparator/Control)
O
Infeksi pada mata
(Outcome)
Apakah penggunaan lensa kontak dapat menyebabkan infeksi
Pertanyaan klinis
mata (keratitis bacterial) ?

2. Menemukan bukti ilmiah terbaik

Proses pencarian telaah jurnal:

Gambar 1. Proses pencarian telaah jurnal

Gambar 2. Proses pencarian telaah jurnal
3. Menilai bukti secara kritis
I. UMUM
YA TIDAK
HAL YANG Isi dengan
NO CHECK LIST PENILAIAN KETERANGAN
DINILAI tanda centang
(✓)
Apakah judul tidak
terlalu panjang atau ✓
terlalu pendek?
Apakah judul
Judul artikel menggambarkan isi utama ✓
1. penelitian?
penelitian
Apakah judul cukup
✓
menarik?
Apakah judul menggunakan
singkatan selain yang baku? ✓
Apakah merupakan
abstrak satu paragraf
Berstruktur
atau abstrak
berstruktur
Apakah sudah
tercakup komponen
2. Abstrak IMRAD
(Introduction, ✓
Method, Results,
Discussion)?
Apakah secara
keseluruhan abstrak ✓
informatif?
 Apakah abstrak lebih
✓
dari 250 kata?

Apakah
mengemukakan
alasan dilakukannya ✓ -
penelitian?
3. Pendahuluan Apakah
menyatakan
hipotesis atau ✓
tujuan
penelitian?
 Apakah pendahuluan
didukung oleh pustaka yang ✓
kuat dan relevan?

Apakah disebutkan
4. Metode desain, tempat dan ✓
waktu penelitian?
Apakah disebutkan
populasi sumber
(populasi ✓ -
terjangkau)?

Apakah kriteria
pemilihan (inklusi
dan ekslusi) ✓
dijelaskan?

Apakah cara pemilihan

subyek (teknik ✓ -
sampling) disebutkan?
Apakah perkiraan
besar sampel
✓
disebutkan dan disebut
pula alasannya?

Apakah perkiraan besar

sampel dihitung dengan ✓
rumus yang sesuai?

Apakah observasi,
pengukuran serta
intervensi dirinci ✓
sehingga orang lain
dapat mengulanginya?

Bila teknik pengukuran

tidak dirinci, apakah ✓ -
disebutkan rujukannya?
Apakah defenisi
istilah dan
variable penting ✓
dikemukakan?

Apakah ethical clerance

diperoleh? ✓

Apakah disebut rencana

analisis, batas kemaknaan ✓
dan power penelitian?
 Apakah disertakan table
deskripsi subyek penelitian? ✓

5. Hasil

Apakah karakteristik
subyek yang penting
(data awal) ✓
dibandingkan
kesetaraannya?
Apakah dilakukan uji
Tidak, karakteristik subyek penelitian tidak dilakukan uji kesetaraan.
hipotesis untuk kesetaraan ✓ Hanya disebutkan jumlahnya tetapi tetap dibandingkan.
ini?
Apakah disebutkan
jumlah subyek yang ✓
diteliti?
Apakah dijelaskan
Dalam penelitian ini tidak disebutkan bahwa terdapat subyek
subyek yang drop out ✓ penelitian yang drop out.
dengan alasannya?

Apakah semua hasil didalam

table disebutkan didalam ✓
naskah?
Apakah semua
outcome yang
penting disebutkan ✓
dalam hasil?

Apakah subyek yang

drop out diikutkan ✓ -
dalam analisis?

Apakah disertakan
hasil uji statistic
(x².t) derajat ✓ -
kebebasan (degree of
freedom) dan nilai p?
Apakah disertakan
✓
hasil uji statistic?
 Apakah semua hal
6. Diskusi yang relevan ✓
dibahas?
Apakah dibahas
keterbatasan
penelitian dan
kemungkinan ✓ -
dampaknya pada
hasil?
Apakah dibahas kesulitan
penelitian, penyimpangan
dari protocol, dan ✓ -
kemungkinan dampaknya
pada hasil?

Apakah
pembahasan
dilakukan dengan
menghubungkann
✓
ya dengan teori
dan hasil
penelitian
terdahulu?

Apakah dibahas
hubungan hasil dengan ✓ -
praktek klinik?
Apakah terdapat
kesimpulan
utama ✓
penelitian?

Apakah kesimpulan
didasarkan pada data ✓
penelitian?
Apakah efek samping
dikemukakan dan dibahas? ✓ Jurnal ini tidak membahas mengenai efek samping suatu intervensi.
Apakah disebutkan hasil Tidak, penelitian ini hanya focus terhadap efek kontak lensa dan
tambahan selama ✓ hubungannya dengan infeksi pada mata (keratitis) yang disebabkan
diobservasi? oleh bakteri.
Apakah disebutkan
✓ -
generalisasi hasil penelitian?
Apakah disertakan saran
penelitian selanjutnya,
✓
dengan anjuran metodologis
yang tepat?
II. KHUSUS
a) Apakah jurnal ini valid (isinya dapat dipercaya): Validity
1. Apakah pasien-pasien grup kontrol dan percobaan diidentifikasi secara jelas
kriteria inklusi dan eksklusinya? Apakah pasien kedua grup (kontrol dan
perlakuan) sifatnya sama?
Ya, kriteria inklusi dan kriteria eksklusi dijelaskan secara jelas pada jurnal
penelitian ini. Dari hasil analisis didapatkan bahwa karakteristik demografik
(usia, gender, waktu, dan lokasi geografis) antara kelompok kontrol dan
kelompok kasus serupa.
2. Apakah pasien grup kontrol dan percobaan mendapatkan perlakuan yang
sama?
Tidak, pada kelompok kasus keratitis dengan penggunaan kontak lensa
dilakukan pemeriksaan menggunakan slit lamp untuk menilai derajat
keparahan dan menentukan tatalaksana yang tepat serta dilakukan pengisian
kuisioner oleh responden pada kelompok kasus. Sedangkan pada kelompok
kontrol responden hanya diminta untuk mengisi kuisioner.
3. Apakah durasi pengamatan cukup lama? Apakah jumlah pasiennya lengkap
dari awal penelitian hingga akhir?
Ya, pengamatan dilakukan cukup lama yaitu selama 5 tahun. Jumlah pasien
komplit, karena tidak ada peserta yang drop out dari penelitian, artinya
jumlah peserta yang drop out < 20% dari jumlah diawal penelitian.
4. Apakah paparan mendahului akibat?
Ya, paparan mendahului akibat karena penelitian ini dilakukan secara
prospektif.
5. Apakah resiko meningkat dengan peningkatan jumlah atau dosis paparan
yang dicurigai berbahaya?
Tidak ada penjelasan terkait peningkatan jumlah atau dosis paparan yang
dicurigai berbahaya pada jurnal ini.
b) Apakah jurnal ini penting? Hasilnya bermakna? Important?
1. Apakah outcome / hasil dipaparkan secara jelas (hasil uji statistik dengan
hasil nilai p)?
Ya, hasil sudah dipaparkan secara jelas didalam jurnal baik pada tabel 2
disertai penjelasan dengan kalimat beserta hasil uji statistik dan nilai p nya.
Data yang signifikan secara statistik didata dalam bentuk tulisan bold.
 Gambar 3. Tabel hasil uji statistik.

2. Seberapa besarkah ketepatan estimasi outcome yang didapat dengan nilai

OR,RR,PR dengan nilai korelasi 95% CI?

Gambar 4. Tabel hasil analisis multivariat.

 P dengan nilai <0,05 menunjukkan adanya hubungan yang signifikan dengan nilai
OR berbeda pada setiap variabelnya. Bila OR > 1 berarti menunjukkan adanya
faktor resiko. Bila OR < 1 menunjukkan adanya faktor protektif. Berdasarkan
tabel diatas menunjukkan diantaranya :

a. Penggunaan lensa kontak semalaman memiliki kecenderungan

mengalami keratitis mikrobia yang ditunjukkan dengan nilai p = <0,001
dgn OR 1,24 ; 95% CI 1,13-1,35.
b. Adaptasi penggunaan lensa kontak dengan bantuan dokter mata juga
berperan sebagai faktor protektif dari terjadinya keratitis mikrobia yang
ditunjukkan dengan nilai p = <0,001 dgn OR 0,73 ; 95% CI 0,68-0,78.

c) Apakah jurnal ini dapat dipakai untuk praktek klinik kita? Applicability
1. Apakah pasien kita mirip dengan subjek yang kita miliki?
Ya, pada kasus yang kami dapatkan pasien ini menanyakan apakah kontak
lensa dapat menyebabkan infeksi pada mata. Dalam jurnal yang kami pilih,
terdapat keterkaitan bahwa penggunaan kontak lensa dapat meningkatkan
resiko infeksi pada mata. Khususnya apabila higienitas tidak dijaga dengan
baik, penggunaan cairan desinfeksi multifungsi, pemilihan material lensa
kontak, dan ketertiban waktu penggantian lensa kontak. Sebaiknya,
penggunaan lensa kontak dikonsultasikan dengan dokter mata untuk
mengurangi resiko terjadinya infeksi pada mata.
2. Apakah bukti ini memiliki pengaruh yang penting secara klinis terhadap
kesembuhan pasien kita? Apa yang ditawarkan/diberikan kepada pasien kita?

Ya, bukti ini bisa memberikan pengaruh dan wawasan yang bagus untuk
pasien. Sehingga nanti pasien dapat lebih hati-hati dan tertib saat
menggunakan lensa kontak untuk mengurangi resiko infeksi pada mata.
Seperti paparan diatas, berikan penejelasan pada pasien untuk memilih lensa
kontak yang sesuai dengan kebutuhan di dokter mata serta rajin untuk kontrol
ke dokter dan gunakan larutan pembersih yang bagus.
 ARTICLE
Risk Factors for Contact Lens–Related Microbial Keratitis:
A Case–Control Multicenter Study
Arnaud Sauer, M.D., Ph.D., Nicolas Meyer, M.D., Ph.D., and Tristan Bourcier, M.D., Ph.D.,
for the French Study Group for Contact Lens–Related Microbial Keratitis
Purpose: The most feared complication of contact lens (CL) wear is
microbial keratitis (MK), even though its incidence remains low. This study
aimed to identify the risk factors of CL-related MK in a large, prospective,
multicenter case–control study.
Methods: A multicenter case–control study was designed. The CL-
related MK subpopulation (Case) was compared with healthy CL wear-
ers (Control) using a 52-item anonymous questionnaire designed to
determine subject demographics and lens wear history. Univariate and
multivariate logistic regression analyses were performed to compare
both groups.
Results: The study enrolled 499 cases and 508 controls. The risk factors
associated with the greatest increased odds of CL-related MK were as
follows: using disinfecting solution more than 3 months (odds ratio
[OR]¼1.94), cosmetic CL wear and use of multipurpose disinfection
solution (1.37 each), overnight wear, and soft lens use (OR¼1.24 each).
The protective factors associated with the greatest reduction in OR were
fitting by an ophthalmologist (OR¼0.73) and hyperopia versus myopia
(OR¼0.75).
From the Service d’Ophtalmologie (A.S., T.B.), Hôpitaux Universitaires
de Strasbourg, Nouvel Hôpital Civil, Strasbourg, France; and Service de
Méthodologie et Biostatistiques (N.M.), Hôpitaux Universitaires de Stras-
bourg, Strasbourg, France.
The authors have no funding or conflicts of interest to disclose.
The French Study Group for Contact Lens–Related Microbial Keratitis:
Florence Abry (Epinal Regional Hospital), Karine Angioi, Jean-Paul Ber-
rod, Jean-Luc Georges (Nancy University Hospital), Florent Aptel, Chris-
tophe Chiquet, Evelyne Leblond (Grenoble University Hospital), Stéphanie
Baillif, Pierre Gastaud (Nice University Hospital), Laurent Ballonzoli, Mar-
tine Cros-Boidevezi, David Gaucher, Jonathan Letsch, Roland Pagot,
Claude Speeg-Schatz (Strasbourg University Hospital), Vincent Borderie,
Laurent Laroche (Centre Hospitalier National d’Ophtalmologie, Paris),
Alain Bron, Catherine Creuzot-Garcher (Dijon University Hospital), Carole
Burillon, Laurent Kodjikian (Lyon University Hospital), Guilhem Cartry
(Perpignan Regional Hospital), Beatrice Cochener (Brest University Hos-
pital), Joseph Colin, Florence Malet (Bordeaux University Hospital), Vin-
cent Daien, Max Villain (Montpellier University Hospital), Bernard
Delbosc Maher Saleh (Besançon University Hospital), Angélique Donnio,
Harold Merle (Fort-de-France University Hospital), Pierre Fournie François
Malecaze, Marie Malecaze-Delfour (Toulouse University Hospital), Gilles
Thuret, Philippe Gain (Saint-Etienne University Hospital), Julie Gueudry,
Marc Muraine (Rouen University Hospital), Louis Hoffart (Marseille Uni-
versity Hospital), Marc Labetoulle (Kremlin-Bicêtre, Paris), Frédéric Mour-
iaux (Caen University Hospital), Pierre-Yves Robert (Limoges University
Hospital), and Bertrand Vabres (Nantes University Hospital).
Address correspondence to Arnaud Sauer, M.D., Ph.D., Service
d’Ophtalmologie, Hôpitaux Universitaires de Strasbourg, Nouvel Hô-
pital Civil, BP 426, 67091 Strasbourg, France; e-mail: arnaud.sauer@
chru-strasbourg.fr
Accepted June 23, 2015.
DOI: 10.1097/ICL.0000000000000180
158
Copyright @ Contact Lens Association of Opthalmologists, Inc. Unauthorized reproduction of this article is prohibited.
Conclusions: The infectious determinants were linked to the type of lenses,
hygiene routine, CL handling, disinfecting solution, and storage case. This
study aimed to highlight the increasingly CL-related MK, which likely
occurs because of lack of patient information regarding basic rules of
hygiene and CL care and handling.
Key Words: Contact lenses—Epidemiology—Infection—Keratitis—Risk
factors.
(Eye & Contact Lens 2016;42: 158–162)
M icrobial keratitis (MK) is a significant vision-threatening
complication sometimes related to the use of contact lenses
(CL). Microbial keratitis has major public health implications, with
approximately 300 million wearers worldwide, and certain poten-
tially modifiable risk factors.1–3 Over the last decade, there has been
a steady increase in CL wearers and MK.4–6 Subsequently, CL
wear now constitutes a major predisposing factor for corneal infec-
tion in the United States and Western Europe, representing from
30% to 50% of all bacterial keratitis cases.7,8 Pathogenesis of CL-
related MK is well known.9 Severe keratitis is most commonly
associated with an environmental causative organism, including
Staphylococcus aureus or Pseudomonas aeruginosa. Pseudomonas
aeruginosa remains of particular interest because of its unique
virulent characteristics and ability to survive in the CL, storage
case, and ocular environment.10–12 However, fungi and Acantha-
moeba are also causative pathogens for CL-related MK.11
Numerous risk factors for CL-related MK have been described.
Despite consistent progress in the quality of both CL materials1,13 and
sterile packaging,1,14 the number of CL-related MK cases has re-
mained roughly constant. Well-designed epidemiologic studies have
shown an increase in the risk of MK for daily wear soft CL when
compared with daily wear rigid CL. Microbial keratitis has an inci-
dence of approximately 1.1:10,000 for rigid CL, 2:10,000 for daily
disposable CL, and 3.5:10,000 for soft CL marketed for disposal after
1 to 4 weeks of wear.1,15 Some risk factors are well known, such as
cosmetic CL wear (to change eye color)16,17 or overnight wear.5,18,19
There have been epidemic increases, such as Acanthamoeba and
fungal keratitis, associated with particular CL solutions.20–22
The risk of CL-related MK may derive from several different
factors: the lens wearer (personal history), their hygiene and
handling routine, type of CL (material, design, modalities of wear,
and replacement schedule), disinfecting solution and storage case,
and the CL dispenser (Ophthalmologist, Optician and Internet
websites). This study was designed to determine the risk factors of
CL-related MK in a prospective multicenter study in France.
Eye & Contact Lens  Volume 42, Number 3, May 2016
 Eye & Contact Lens  Volume 42, Number 3, May 2016 Contact Lens–Related Microbial Keratitis

METHODS cases, yielding crude OR. The sample size justification was deter-
mined as follows. Because of the increasingly documented dan-
Design gers of freely available cosmetic CL without professional
A prospective, multicenter case–control study was carried out in
supervision, as it is the case notably in France, the main outcome
22 university and regional hospitals all over France (Besançon,
was lack of CL dispensed by an ophthalmologist. With a 5% type
Bordeaux, Brest, Caen, Dijon, Epinal, Fort-de-France, Grenoble,
I error rate and a 90% power, a total sample size of 740 subjects
Limoges, Lyon, Marseille, Montpellier, Nancy, Nantes, Nice, Paris
was required to ascertain an OR of 2.4 with a proportion of
Kremlin-Bicêtre, Paris XV-XX, Perpignan, Rouen, Saint-Etienne,
control and case subjects without ophthalmologic dispensation
Toulouse, and Strasbourg) and in medical offices of 11 private
of 6% (proportion observed on previous data) and 13.4%, respec-
practice ophthalmologist members of the “Société Française des
tively. The sample size was computed with NCSS-PASS 2005.
Ophtalmologsistes Adaptateurs de Lentilles de Contact” (French
Society of Ophthalmologists’ Contact Lenses Dispensers), over
a 5-year period that started in July 2007.
The inclusion criterion for cases was the occurrence of severe
RESULTS
MK after the use of CL. All patients with CL-related MK first had The study enrolled 499 CL-related MK (Case) and 508 CL
a slitlamp examination to determine the severity and the treatment wearers with no corneal disease (Control). Culture was positive
of the corneal abscess. Microbial keratitis was defined as for 78% of the cases (391 cases). Best corrected acuity was lost for
a suppurative corneal infiltrate and overlying epithelial defect 178 cases (36%). Demographic features were similar in both
associated with the presence of microorganism on corneal scraping patient groups (Table 1). Results of univariate analysis are shown
and/or that was cured with antibiotic therapy. Severe MK was in Table 2 and those of multivariate analysis in Table 3.
defined with the following features leading to hospital care: (1)
presence of anterior chamber flare, (2) any part of the lesion being Univariate Analysis
in the central 3 mm of the cornea, and (3) lesion diameters greater Comparative data with univariate ORs for the risk factors
than 2 mm. All patients were asked to fill a 52-item anonymous relative to the 499 CL-related MK patients (Case) and 508 healthy
standardized questionnaire after their examination. wearers (Control) are provided in Table 2.
Controls were healthy wearers prospectively taken from the Most patients wore CL for refractive errors, but cosmetic CL
same clinical site as patients. The analysis of included patients exhibited a greater risk for MK (OR¼5.88 [2.90–11.60],
revealed that cases and controls had similar demographic features P,0.0001). The risk of CL-related MK decreased with a regular
(age, gender, time, and geographical inclusion). Contact lens– (annual) ophthalmologist follow-up (OR¼0.24 [0.18–0.32],
related MK patients (Case) were studied and compared with CL P,0.0001). Furthermore, ophthalmologist CL fitting decreased the
wearers (Control). MK risk (OR¼0.12 [0.08–0.19], P,0.0001). In this study, optician
The protocol was approved by the local ethics committee (OR¼6.90 [4.54–10.53], P,0.0001), Internet, or friend dispensation
(Strasbourg, France) in accordance to Helsinki adherence to the increased the MK risk. Exceeding the delay of CL renewal clearly
tenets of the Declaration of Helsinki and with national restrictions increased the MK risk (OR¼2.90 [2.15–3.91], P,0.001).
(Commission Natinale de l’Informatique et des Libertés—Declara- The use of multipurpose solution increased the relative MK risk
tion 1808523v0). The protocol was approved by the local ethics (OR¼4.50 [3.12–6.50], P,0.0001), whereas the renewal of CL
committee. All the subjects provided written informed consent. cases (OR¼0.14 [0.11–0.20], P,0.001) and solution (OR¼0.62
[0.45–0.85], P,0.0001) within a 3-month period was found to
be protective.
Questionnaire Relative to the CL material, rigid gas permeable CL were found
Patients completed a 52-item anonymous standardized paper to be safe with a protective OR (OR¼0.34 [0.21–0.57],
questionnaire, which provided data on potential risk factors, P,0.0001). An increased OR was observed with soft CL
including demographic data (age, gender, and educational level), (OR¼2.94 [1.75–4.76], P,0.0001). An increased relative risk
patient medical history and concomitant treatment, CL wear
history (age of first use, years of wear), reason for wearing CL
(ametropia, plano [cosmetic] lenses used for change iris color), TABLE 1. Demographic Data and Lens Types for the 499 CL-Related
lens type (soft or hard), wear schedule (frequency of disposal, MK Patients (Case) and the 508 Healthy Wearers (Control)
replacement frequency, and overnight wear), CL hygiene compli- CL-Related MK Healthy CL Wearers
ance (hand washing and lens care), and disinfecting solution and Demographic and Clinical Data (Case) (Control)
lens case used.16,23 N 499 508
Age, mean (SD) 30.9 (8.2) 29.9 (11.3)
Gender (% women) 77 73
Statistical Analyses Age of first prescription, 20.9 (7.0) 19.4 (5.4)
Logistic regression was conducted to study the effects of mean (SD)
covariates. Results were given as odds ratio (OR) with 95% Years of CL wear, mean (SD) 10.6 (6.9) 9.5 (7.3)
Soft CL
confidence interval and P value. A P value less than 0.05 was Daily disposable, n (%) 55 (11) 36 (7)
considered statistically significant. Daily disposable lens wearers Monthly renewable, n (%) 314 (63) 310 (61)
Two-weekly renewable, n (%) 100 (20) 61 (12)
were excluded from the analysis for the outcomes concerning Rigid gas permeable CL 25 (5) 61 (12)
disinfecting solution, lens case, or rub and rinse steps. Multivar-
iate stepwise logistic regression was performed by multiple impu- P,0.05 was considered significant.
tation, with univariate logistic regression carried out on complete CL, contact lens; MK, microbial keratitis; SD, standard deviation.

Ó 2015 Contact Lens Association of Ophthalmologists 159

Copyright @ Contact Lens Association of Opthalmologists, Inc. Unauthorized reproduction of this article is prohibited.
 A. Sauer et al. Eye & Contact Lens  Volume 42, Number 3, May 2016

TABLE 2. Comparative Data With Univariate Odds Ratios for the Risk Factors Relative to the 499 CL-Related MK Patients (Case) and 508 Healthy
Wearers (Control)
Patients in Case Group, Patients in Control Group, Odds Ratio
CL-Related MK Risk Factors % % (95% confidence interval) P

Risk factors relative to the patients

Refractive indication 88.2 96.2 0.29 (0.17–0.51) ,0.0001
Myopia 69.7 64.9 0.98 (0.76–1.27) 0.887
Hyperopia 2.0 5.9 0.29 (0.14–0.64) 0.002
Astigmatism 18.1 24.1 0.64 (0.46–0.88) 0.005
Presbyopia 9.3 5 1.77 (1.05–2.99) 0.033
Corneal disease 0.2 1.3 6.51 (0.78–54.30) 0.083
Cosmetic lenses 11.2 2.1 5.88 (2.90–11.60) ,0.0001
Once a year ophthalmologic follow-up 36.2 61.8 0.24 (0.18–0.32) ,0.0001
Ophthalmologist adaptation 65.2 93.9 0.12 (0.08–0.19) ,0.001
Optician adaptation 31.0 6.1 6.9 (4.54–10.53) ,0.001
Others dispensation (Internet, friends .) 3.8 0.0 NA NA
Handling education 63.8 75.3 0.58 (0.44–0.76) ,0.0001
Information about lens care and hygiene 67.8 88.0 0.29 (0.21–0.40) ,0.0001
Exceeds the CL recommended renewal schedule 38.1 17.5 2.90 (2.15–3.91) ,0.0001
Former episode of CL-related MK 43.4 23.0 2.60 (1.90–3.40) ,0.0001
Personal history of allergy 7.2 18.0 0.35 (0.23–0.64) ,0.0001
Dry eye disease 22.1 18.9 1.22 (0.90–1.68) 0.203
Screen workers 63.3 50.5 1.69 (1.31–2.19) ,0.0001
Working in an air-conditioned area 24.5 6.8 4.47 (3.01–6.84) ,0.0001
Active smoker 34.2 28.5 1.44 (0.98–1.90) 0.065
Depression 4.2 2.2 1.78 (1.21–2.63) 0.004
Daily use of oral medication 27.7 18.9 1.24 (0.91–1.71) 0.174
Living in a country area (vs. Urban area) 30.3 27.9 1.12 (0.85–1.48) 0.415
Recent plane trip 11.7 41.4 0.19 (0.11–0.32) ,0.0001
Risk factors related to hygiene and handling and to the solution
and the lens case
No hand washing 33.7 26.4 1.51 (1.11–2.06) 0.0115
Use of soap 74.6 86.5 0.46 (0.31–0.67) ,0.0001
Saliva utilization 2.2 3.6 0.59 (0.28–1.29) 0.189
Rub and rinse procedure 11.2 19.2 0.53 (0.35–0.79) 0.002
CL and swimming pool 71.6 61.6 2.10 (1.78–2.42) 0.012
Multipurpose vs. oxidative disinfection solutions 87.1 60.1 4.50 (3.12–6.50) ,0.0001
Renewal of case ,3 mo 57.2 83.2 0.14 (0.11–0.20) ,0.0001
Renewal of disinfecting solution ,3 mo 72.2 81.0 0.62 (0.45–0.85) 0.004
Risk factors relative to the CL
Rigid gas permeable CL 4.3 11.6 0.34 (0.21–0.57) ,0.0001
Soft CL 95.7 88.4 2.94 (1.75–4.76) ,0.0001
Monthly renewable 62.7 59.3 1.15 (0.89–1.49) 0.276
Daily disposable 11.0 6.3 1.83 (1.15–2.90) 0.01
Two-weekly renewable 20.2 11.0 2.06 (1.44–2.95) ,0.0001
Silicone hydrogel 45.2 38.4 1.84 (1.30–2.59) 0.001
Overnight wear 2.6 0.4 6.17 (1.39–27.77) 0.017

Results are given as percentage of patients in each group, odds ratio (OR) with 95% confidence interval and P value.
Statistically significant data appears in bold.
CL, contact lens; MK, microbial keratitis; NA, not applicable.

was observed with silicone hydrogel CL (OR¼1.84 [1.30–2.59],
P¼0.001) and overnight wear CL (OR¼6.17 [1.39–27.77],
P¼0.017). Daily disposable CL (OR¼1.83 [1.15–2.90], P¼0.01)
and 2-weekly replacement CL (OR¼2.06 [1.44–2.95], P,0.0001)
were associated with a higher relative risk. The mean wearing time
for daily disposable CL was 13.463.9 hr, which was not statisti-
cally different from that for 2-weekly replacement CL (13.562.8
hr, P¼0.41) and monthly replacement CL (12.963.6 hr, P¼0.19).
Patients using daily disposable CL were found to exceed the rec-
ommended replacement frequency in 34% of cases, compared with
21% for 2-weekly replacement CL (mean time of wear of
22.6610.5 days, P¼0.07) and 17% for monthly replacement CL
(mean time of wear of 35.7621.9 days, P¼0.04).
Results of Multivariate Logistic Regression
The risk factors associated with the greatest increased odds of CL-
related MK were as follows: using disinfecting solution more than 3
months (OR¼1.94), cosmetic CL wear and use of multipurpose
disinfection solution (OR¼1.37 each), and overnight wear and soft
lens use (OR¼1.24 each). The protective factors associated with the
greatest reduction in OR were fitting by an ophthalmologist
(OR¼0.73) and hyperopia versus myopia (OR¼0.75).
Results of multivariate logistic regression (with multiple impu-
tations) are given in Table 3.
DISCUSSION
This study has provided the most extensive CL-related MK case
series to date, in addition to a sample of control patients from all
over France, which allows us to extrapolate our findings to CL
users from similar environments. Contact lens wearers were mainly
women, aged approximately 30 years, with a history of CL use of 9
years on average. According to the study results, the risk of CL-
related MK was shown to be dependent on a connection between
different factors: the lens wearer (personal history), hygiene and

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 Eye & Contact Lens  Volume 42, Number 3, May 2016 Contact Lens–Related Microbial Keratitis

TABLE 3. Results of Multivariate Logistic Regression, With Multiple attention to hygiene, thus resulting in risk reduction.11,26 A reduc-
Imputation tion in morbidity may be achieved through the recognition of
CL-Related MK Risk Factors, Multivariate Analysis appropriate risk factors, such as hygiene standards and correct
storage case use. As previously published,1,5 giving information
OR (95% confidence
Variable interval) P
about lens care and hygiene (i.e., hand washing, use of soap, and
“rub and rinse” practice at CL insertion) was shown to dramatically
Age of first prescription 1.032 (1.013–1.052) ,0.001 reduce the relative risk of MK in our study. Surprisingly, hand
Hyperopia 0.75 (0.66–0.86) ,0.001
Astigmatism 0.96 (0.90–1.03) 0.26 washing, use of soap, and rub and rinse practice when removing
Presbyopia 0.97 (0.87–1.07) 0.49 the CL seem to increase the risk of MK. This fact deserves to be
No refractive errors 0.89 (0.81–0.99) 0.03
Soft CL vs. rigid gas permeable CL 1.24 (1.24–1.41) 0.001
studied on a larger cohort as it finds no obvious explanation in our
Cosmetic 1.37 (1.14–1.65) ,0.001 study. Without any evident errors in the hygiene and handling
Overnight wear 1.24 (1.13–1.35) ,0.001 routine, some patients nevertheless had MK. This highlights the
Exceeding the CL recommended 1.11 (1.05–1.18) ,0.001
replacement schedule contribution of other factors, such as the lenses themselves or
CL adaptation by an ophthalmologist 0.73 (0.68–0.78) ,0.001 disinfecting solution types, in the pathogenesis of MK.
(vs. optician or self-adaptation) There was a substantial body of evidence emerging from the use
History of MK 1.17 (1.10–1.25) ,0.001
Hygiene routine before insertion of CL 0.95 (0.93–0.97) ,0.001 of silicone hydrogel material and the risks of MK. Previous studies
(hand washing, rub and rinse) hypothesized that the increased relative risk of silicone hydrogel
Hygiene routine before removing CL 1.06 (1.03–1.08) ,0.001
(hand washing, rub and rinse)
CL was secondary to extended wear.5,27 In our study, multivariate
Using disinfecting solution more than 3 mo 1.94 (1.77–2.12) ,0.001 analysis isolated the effect of overnight wear of silicone hydrogel
Using multipurpose disinfecting solution 1.37 (1.14–1.65) ,0.001 materials as an independent risk factor (OR¼1.24).5,19 More sur-
History of eye allergy 0.76 (0.70–0.83) ,0.001
Working in air conditioning 1.22 (1.14–1.31) ,0.001 prisingly, an increased relative risk with daily disposable and 2-
weekly replacement CL was also observed in our study in the
Clinical or statistically significant results. Results are given as odds univariate analysis. Our findings demonstrated that daily dispos-
ratio (OR) with 95% confidence interval and P value.
able CL wearers frequently exceed the recommended CL replace-
Statistically significant data appears in bold. ment delay. The other factors that increased the MK risk were
CL, contact lens; MK, microbial keratitis. linked to the disinfecting solution and storage case. In our study,
patients using multipurpose solutions or those exceeding a 3-month
handling routine, CL themselves (material, design, modalities of delay for the renewal of the CL case or disinfecting solution expe-
wear, and replacement schedule), disinfecting solution, lens case, rienced an increased risk of infectious complications. Patients
and the eye care professional.5 should be reminded that they must clean and disinfect their CL
One finding arising from this study was that MK may occur in cases daily, avoid the use of tap water for rinsing, not top up their
new or experienced CL wearers having worn CL for several years. solutions, and replace the CL cases regularly.28,29 These elements
Eye care professionals should be vigilant in reinforcing hygiene highlight the need for an eye care professional’s advice to use the
messages to all wearers through-out their follow-up.1,23 Ignorance safest combination of CL case and disinfecting solution, thereby
or negligence of basic hygiene rules is probably involved in CL- limiting the risk of MK.
related MK occurrence. In conclusion, several factors could predispose for MK in CL
Generally, most patients wear CL for refractive purposes. In this wearers. The risk factors associated with the greatest increased
study, we demonstrated an increased risk of CL-related MK in odds of CL-related MK were using disinfecting solution more than
patients with presbyopia, whereas astigmatism and hyperopia 3 months (OR¼1.94), cosmetic CL wear and use of multipurpose
(OR¼0.75 in multivariate analysis) were found to be protective. disinfection solution (OR¼1.37 each), and overnight wear and soft
As previously published, this can be accounted for by a prolonged lens use (OR¼1.24 each). The protective factors associated with
daily wear, long history of CL use (CL wearers progressively give the greatest reduction in OR were fitting by an ophthalmologist
into good habits), and difficulties related to CL handling and mod- (OR¼0.73) and hyperopia versus myopia (OR¼0.75).
ification of tear film circulation in presbyopic patients.24 In line
with previously published data, our study confirmed that cosmetic
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