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8/13/2019 Subconjunctival Dexamethasone Implant
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Subconjunctival dexamethasone
implant
for non-necrotizing scleritis
Heloisa Nascimento1*, Mara Frana1, Luciana Guadalupe Garca2,
Cristina Muccioli1 and Rubens Belfort Jr1
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Background
Anterior scleritis isusually a chronic,
painful, progressive,
potentially blinding
conditioninvolving both
the episclera and the
sclera.Divided in diffuse,
nodular, and sectorial
scleritis depending on
the clinical appearance
Often associated with
ocular complications
(anterior uveitis,
peripheral keratitis, and
glaucoma), potentially
causing decrease ofvision, and with systemic
connective tissue or
vasculitic diseases, some
of them potentially lethal
Topical eyedrops
frequently are
ineffective. Systemic
administration of
nonsteroidal anti-
inflammatory drugs
(NSAIDs),
corticosteroids,
nonsteroidal
immunosuppressive
agents, or a
combination, is the
mainstay of
treatment for
noninfectious scleritis
Regional steroid injections have been
successfully used
in the treatment of scleritis
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Background
Regional steroids have been avoided in the
treatment of scleritis because of concerns about
the risk of scleral thinning or perforation.
Subconjunctival steroid injections have become part of the
legitimate armamentarium for scleritis treatment in the lastdecade.It may be an attractive adjunct to systemic therapy by
achieving timely improvement while systemic medications
begin to take effect.
Dexamethasone (DEX) 0.7 mg implant (OzurdexW,Allergan, Inc., CA, USA) is a biodegradable implant
approved by FDA. It was designed to be injected into
the eye (vitreous) to treat adults with macular
edema following branch retinal vein occlusion or
central retinal vein occlusion.
This implant represents a newapproach to the treatment of ocular
diseasessince it is capable to
promote a 3-day local pulse therapy
followed by a 6-month gradually
sustained release when it is placed in
the vitreous
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Materials and Methods
Scleritis was diagnosed on the basis of the
characteristic clinical picture of painful
inflammation and tenderness that radiated to
the forehead, brow, jaw, or sinuses, with
edema affecting the episcleral and scleral
tissues, and injection of both the superficial
and deep episcleral vessels.
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Materials and Methods
Patients with infectious refractory non-
necrotizing anterior diffuse, sectorial, or
nodular scleritis despite adequate treatment
that required steroid therapy were referred
for single-dose DEX 0.7 mg subconjunctival
slow delivery implant according to investigator
judgment.
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Materials and Methods
Single-dose DEX 0.7 mg implant was performedwith the patient seated at the slit lamp. Beforethe procedure, topical anesthesia and 5% iodine-
povidine solution were instilled. After the procedure, patients received local
prophylactic antibiotic regimen for 7 days.
Patients were followed 1, 7, 15, 30, and 45 days,
and 2, 3, 4, 5, and 6 months post-procedure(visual acuity, intraocular pressure (IOP), anteriorand posterior biomicroscopy, and fundus exams)
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Results
Six patients with non-necrotizing anteriornodular, sectorial, or diffuse refractory scleritiswere included in this study (Table 1). Four
were female and two were male. Mean age was 39.8 years (range 28 to 60
years).
Two patients presented scleritis related torheumatoid arthritis, one probably related totuberculosis, and three were idiopathic.
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Results
All patients were on stable systemic or localtherapy, and no increase to their therapy wasmade prior to enrolment in this study.
In all patients, symptoms disappeared before day7, and most of them were symptoms-free on day2.
One recurrence was noted in the 6-month follow-
up in a patient with rheumatoid arthritis anddiffuse scleritis, and was treated with oralsteroids.
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Discussion
Nonsteroidal anti-inflammatory drugs can lead to
gastrointestinal issues including ulcers and
gastritis.
Steroidal drugs can worsen systemic conditions as
diabetes and arterial hypertension.
Immunosuppressive agents may have significant
side effects and may not be safe for individualswith comorbidities and those who are pregnant.
Also, it can increase the risk of malignancies.
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Discussion
The Systemic Immunosuppressive Therapy for
Eye Diseases study has recently shown data
regarding the overall mortality or cancer
mortality after treatment with biological
response modifiers (BRM) for inflammatory
diseases. Because of these reasons, BRM
agents are not first-line therapy for scleritis.
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Discussion
OzurdexW (Allergan, Inc.) has already obtained FDAapproval for intravitreal use for macular edema due tononinfectious uveitis or retinal vein occlusions.
It had never been used before for scleritis andsubconjunctivally.
Although patients of this study had been refractory tothe treatment of scleritis, only one recurrence wasnoted in the 6-month follow-up, which suggests that
steroid slow release directly to the sclera can becrucial in scleritis physiopathology and management.
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Discussion
In these cases, one advantage of controlling
scleritis locally is not to expose the patient to
the risks of systemic immunosuppression.
Also, signs and symptoms of the potential
causative disease would not be masked by the
systemic immunosuppression, possibly
allowing the proper diagnosis andmanagement of the potential underlying
disease.
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Discussion
There is also a general concern about IOP
increase with the use of local steroids.
However, it was not noted in any scleritis
patient treated with subconjunctival
dexamethasone implant. More studies need
to be performed to better elucidate this issue.
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Conclusion
Single-dose DEX 0.7 mg implant was safely andeffectively used for the local treatment of non-necrotizing anterior scleritis. Potential advantages
could include easier steroid removal in case ofcomplications such as scleral melting orglaucoma.
Also, it would not mask systemic diseases, signs,
and symptoms, allowing proper diagnosis of thescleritis cause.
Cost-effective relationship should be assessed.
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No. Kriteria ya (+), tidak (-)
1. Abstrak 1 paragraf +
2. Mencakup IMRC +
3. Secara keseluruhan Informatif +
4. Tanpa singkatan selain yang baku +
5. Kurang dari 250 kata +
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No. Kriteria Ya (+), tidak (-)
1. Terdiri dari 2 bagian atau 2 paragraf -
2. Paragraf pertama mengemukakan
alasan dilakukan penelitian
+
3. Paragraf ke 2 menyatakan hipotesis
atau tujuan penelitian
-
4. Didukung oleh pustaka yang relevan +
5. Kurang dari 1 halaman +
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No Kriteria Ya (+), tidak (-)
1 Jenis dan rancangan penelitian -
2 Waktu dan tempat penelitian Waktu -, tempat -
3 Populasi sumber -
4 Teknik sampling -
5 Kriteria inklusi +
6 Kriteria eksklusi +
7 Perkiraan & perhitungan besar sampel -
8 Perincian cara penelitian +
9 Blind -
10 Uji statistik -
11 Program komputer - (tidak disebutkan)
12 Persetujuan subjektif + (Inform consent)
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No. Kriteria Ya (+),tidak (-)
1 Jumlah subjek +
2 Tabel karakteristik subjek -
3 Tabel hasil penelitian +
4 Komentar dan pendapat penulis ttg hasil +
5 Tabel analisis data dengan uji -
8/13/2019 Subconjunctival Dexamethasone Implant
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No. Kriteria Ya (+), tidak (-)
1 Pembahasan dan kesimpulan terpisah -
2 Pembahasan & kesimpulan dipaparkan dengan jelas +
3 Pembahasan mengacu dari penelitian sebelumnya -
4 Pembahasan sesuai landasan teori +
5 Keterbatasan penelitian -
6 Simpulan utama +
7 Simpulan berdasarkan penelitian -
8 Saran penelitian -
9 Penulisan daftar pustaka sesuai aturan +
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Apakah penelitian ini valid ? Valid
Apakah penelitian ini penting ? Penting untuk
mempertimbangkan alternatif lain dalam pengobatan non-
necrotizing scleritis
Apakah pasien kita terhadap perbedaan dgn subjek penelitian ?
Ya, terdapat perbedaan karakteristik subjek antara di Indonesia
dengan tempat penelitian ini
Apakah terapi tersebut mungkin untuk diterapkan pada pasien
kita ? Perlu dipertimbangkan krn penelitian ini memiliki sampel
yg minimal shg dianggap blm dapat mewakili populasi umum.