entodinternational.com* For Use By Medical Professionals Only
September’ 2013 EDITION 3
Entod Research Cell Ltd. (UK) Op's ha ti hd an lI m g icni Es xa c pew ro tih seS «»
Lacrimal Sac Leavage with India’s First
Terminally Sterilised Pre-Filled Syringe Moxifloxacin
September’ 13 EDITION 3
PFS(Moxifloxacin 0.5%)
1ml
ILF LE ER DP
NI GR EY
S
Terminally
Sterilized by
Autoclave
* F
or
Use
By
Medic
al P
rofe
ssio
nals
Only
India’s First Intraoperative Moxifloxacin Syringe
Purpose:
To evaluate the efficacy of Lacrimal Sac Leavage with
Moxifloxacin0.5% ophthalmic Solution (4 Quin™ PFS
prefilled syringe, Entod Pharmaceuticals Ltd. [India])
0.5% as treatment of Canaliculitis / Dacryocystitis.
Design:
This is a parallel randomized interventional study to evaluate
the efficacy of Lacrimal Sac Leavage with Moxifloxacin 0.5%
ophthalmic Solution as treatment of Canaliculitis/
Dacryocystitis.
Introduction:
Dacryocystitis:
Inflammation of the nasolacrimal sac frequently caused by
nasolacrimal ductobstruction or infection Greek dákryon
(tear) cysta (sac), and –it is (inflammation).
Dacryocystitis may be classified as acute, sub-acute, or
chronic. It may be localized in the sac, extended to include a
pericystitis, or progressed to orbital cellulitis.
Clinical features:
• Pain, swelling, redness over the lacrimal sac
enlargement at medial canthus.ENTOD RESEARCH CELL LTD. (UK)33 Stanley Road, London N15 3HB Email: [email protected]
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Dr. Hadi Khazaei
Head of Department, Ocular Oncology, Oculoplasty & Orbit Service, Narayana Nethralaya (Benguluru, India)
DACRYOCYSTITIS:
• Tearing, crusting, fever.
• Digital pressure over the lacrimal sac may extrude
pus through the punctum.
• In chronic cases tearing may be the only symptom.
Causative organisms:
Most commonly caused by Staphylococcus aureus and
Streptococcus pneumoniae.*
Canaliculitis:
Signs and symptoms:
• Predominantly affects individuals over age 50
• Complaints center on a chronic, recalcitrant
unilateral red eye, and often epiphora.
• Discharge may range from a simple watery
consistency to full-blown mucopurulence.
• In many cases the patient will report previous
therapy with topical antibiotics.
• Recurrent episodes are common.
• Bio-microscopic inspection reveals a classic "pouting
punctum" in the involved eye--that is, the punctal
orifice is red, swollen and turned outward, like
pouting lips.
• Involved area is often tender to touch.
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Pyrogen Free Production
Terminally Sterilised for Maximum Sterility
Automated Manufacturing with No Human Touch
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Op's ha ti hd an lI m g icni Es xa pc ew ro tih seS «»
September’ 13 September’ 13EDITION 3 EDITION 3
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Printed with Permission from: Dr. Hadi Khazaei,
To Contact Dr. Hadi Khazaei, Email: [email protected]
Head of Department, Ocular Oncology, Oculoplasty & Orbit Service, Narayana Nethralaya (Benguluru, India)
* For Medical Professionals Use Only
Hyderabad, India.
4)Prevalence of bacterial pathogens causing ocular
infections in South India. Ramesh S, Ramakrishnan R,
Bharathi MJ, Amuthan M, Viswanathan S. Source Aravind Eye
Hospital & Postgraduate Institute of Ophthalmology,
Tirunelveli, Tamil Nadu- 627001, India.
5) Primary canaliculitis. Zaldívar RA, Bradley EA. Source
Department of Ophthalmology, Mayo Clinic and Mayo
Foundation, Rochester, Minnesota 55905, USA.
6)Bacteriology of chronic dacryocystitis in adult population
of northeast India. Das JK, Deka AC, Kuri GC, Bhattacharjee K,
Das D, Gogoi K. Source Sri Sankardeva Nethralaya, Beltola,
Guwahati, Assam, India. [email protected] [corrected]
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• Digital manipulation of the punctum and/or
canaliculi may express discharge and/or concretions.
• Other important signs include erythema and swelling
of the lid and adnexal tissue, and a conjunctivitis
that is most pronounced inferiorly and nasally.
• Lacrimal probing reveals additional diagnostic signs.
• You will encounter a "soft stop" while probing the
canaliculus. This blockage indicates the presence of
concretions within the drainage system.
• Concurrent with this finding is the so-called "wrinkle
sign"; as your probe meets resistance, the overlying
skin of the medial canthus may compress and
wrinkle.
Causative organisms:
• Most often cause are bacterial pathogens
(Fusobacterium, Nocardia pathogens) though it can
also result from fungal or viral infections. In older
individuals, Actinomyces Israelii is the primary
etiology.
• Those under age 20 who present with canaliculitis
are more likely to manifest primary herpetic
infections.
• Other less common etiologies include Candida,
Fusarium and Aspergillus species.
Management:
Medical Treatment:
• In the presence of frank dacryocystitis: the cardinal
rule is to first treat the infection. The antibiotic of
choice is an anti-staphylococcal one, such as
aminoglycosides or fluoroquinolones group of drugs
e.g. cloxacillin (oral), moxifloxacin (topical).
Surgical Treatment:
• If the infection does not resolve and perforation is
impending: a dacryocystotomy should be performed.
• Relief of nasolacrimal duct obstruction by
dacryocystorhinostomy (DCR).
1. External or
2. Endonasal/ Endoscopic
Management of canaliculitis is twofold:
• Physical removal of associated foreign matter and
vigorous antimicrobial therapy. Small dacryoliths and
other debris may be expressed through the punctum
with direct manipulation using a cotton-tipped
applicator or lacrimal leavage using appropriate
solutions e.g. Moxifloxacin 0.5%.
• Larger or numerous stones often require surgical
canaliculotomy.
• Institute antimicrobial therapy only after alleviating
the blockage.
• Treatment options depend on the offending agent.
Obtain smears and cultures from the extruded
canalicular material.
• In cases of bacterial infection, irrigate (lacrimal
leavage) the canaliculus with moxifloxacin 0.5%
solution. Usually, you will then follow-up with topical
therapy (moxifloxacin ophthalmic solution) and
systemic antibiosis (penicillin or ampicillin) for 1-2
weeks.
• Treatment for herpetic infection consists of topical
trifluridine 1% five times daily for 2-3 weeks. Address
fungal infections by using nystatin 1:20,000
ophthalmic solution tid, as well as bi-weekly nystatin
irrigation.
• In case of actinomycosis and nocardia canaliculitis
amikacin ophthalmic solution can be effective after
frequent canalicular and sac leavage using
appropriate antimicrobial solutions.
• If treatment fails to eradicate the problem, or if
canalicular potency cannot be restored, a
dacryocystorhinostomy may be required.
Method:
Over 100 Patient with Post-Surgical Canaliculitis/
Dacryocystitis were enrolled in this parallel randomized
interventional study, which were further categorized into 2
groups, the treatment group (Group A) receiving 0.5 ml
lacrimal sac leavage with Moxifloxacin 0.5% ophthalmic
solution (4 Quin™ PFS prefilled syringe, Entod
Pharmaceuticals Ltd. [India]) 24hours after surgical
intervention for Chronic Dacryocystitis/ Canaliculitis, and the
control group (Group B) which received 0.5 ml of aqua
destilata (placebo) a day after their treatment. Clinical
observation of the symptoms in each group was performed
on the first until the sixth day after the inoculation using a
clinical grading scale. On the sixth day, the inoculated eyes
were examined for microbiological evaluations.
Results:
The total clinical grading scores of each group were similar
24hours after surgical intervention for Chronic
Dacryocystitis (P > 0.05). The total clinical grading scores of
Group A on the sixth day and the difference in total clinical
scores on the first and the sixth day were shown to be
significantly lower than that of Group B (P<0.05).
Microbiological analysis revealed that there was a lower
bacterial count in Group A (mean =1.16 ± 0.83 log CFU/ 0.1
mL) compared with Group B (mean = 3.04 ± 0.51logCFU/0.1
mL).
Conclusion:
Lacrimal Sac Leavage with Moxifloxacin 0.5% ophthalmic
solution(4 Quin™ PFS prefi l led syringe, Entod
Pharmaceuticals Ltd. [India]) 24 hours after surgical
intervention for Chronic Dacryocystitis appeared to be
effective and safe.
References:
1) Clinical bacteriology of dacryocystitis in adults.Coden DJ,
Hornblass A, Haas BD. Source Department of
Ophthalmology, University of California, San Diego
2) Clinical bacteriology of dacryocystitis in adults. Coden DJ,
Hornblass A, Haas BD. Source Department of
Ophthalmology, University of California, San Diego.
3) Primary canaliculitis: clinical features, microbiological
profile, and management outcome. Kaliki S, Ali MJ, Honavar
SG, Chandrasekhar G, Naik MN. Source Department of
Ophthalmic Plastic Surgery, LV Prasad Eye Institute,