Download RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA,
BANGALORE
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1.
Name of candidate and
address
Dr. SYED WASIF
ROOM NO.109,
KIMS BOYS HOSTEL
BANASHANKARI II STAGE
BANGALORE – 560 070
2
Name of the institution
KEMPEGOWDA INSTITUTE OF MEDICAL
SCIENCES, BANGALORE – 560 070
3
Course of the study &
subject
M.D. IN PHARMACOLOGY
4
Date of admission to course
27TH MAY 2010
Title of the topic
A PROSPECTIVE STUDY OF THE PATTERN
OF TOPICAL ANTIMICROBIAL USE IN
SUPERFICIAL OCULAR INFECTIONS IN
A TERTIARY CARE HOSPITAL
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______________________________________________________________________________
6.
Brief resume of the intended work
6.1
Need for study
Ocular infections are caused by a variety of microrganisms like bacteria, viruses,
fungi and protozoa. Though some of the infections may be self-limiting, the severe,
chronic or recurrent infections, if not treated promptly and effectively, may lead to
impairment or loss of vision.
Superficial ocular infections like conjunctivitis, keratitis and anterior uveitis are
usually treated with topical antimicrobial agents (AMAs) in the form of eye drops or
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ointments, whereas infections involving deeper, intraocular, posterior segment or
periocular structures may require systemic or intralesional administration. The topical
application is a non-invasive and convenient procedure ensuring high local concentration
of the drug, minimizing systemic adverse effects. However, indiscriminate use of topical
AMAs may cause irritation with histological and ultra structural changes in conjunctiva
and also delaying the healing process.
The selection of topical AMAs is usually empirical, depending upon the clinical
features, prevailing pattern of infections, the likely causative organisms and their
anticipated susceptibility/resistance, and the local pharmacokinetics of the agents.
Bacteriological studies like culture and sensitivity are usually not undertaken except for
chronic, recurrent or complicated infections.
Though topical AMAs are used routinely and extensively in ophthalmic practice,
there is paucity of published reports in the Indian literature regarding their pattern of use,
and evaluation of their efficacy, safety, tolerability and clinical outcome. Hence, the
present study is taken up.
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6.2
Review of literature
Ocular infections may involve superficial structures like conjunctiva, cornea,
eyelids, sclera and lacrimal sac, or deeper structures like uveal tract, vitreous humour,
choroid, retina and optic nerve. The causative pathogens may be bacteria, viruses,
chlamydia, fungi, protozoa or parasites. Common pathogens include bacteria such as
Staphylococcus aureus, Staphylococcus albus, Haemophilus aegyptius, Haemophilus
influenzae, Neisseria gonorrhoeae, Neisseria meningitides, Streptococcus pyogenes,
Streptococcus pneumoniae, Moraxella lacunata, Escherichia coli, diphtheroids, etc.
Common viruses causing ocular infections include Herpes simplex virus, adenoviruses,
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picornaviruses such as Coxsackie virus, Enterovirus 70, myxovirus such as measles,
paramyxoviruses like mumps, Newcastle conjunctivitis, Molluscum contagiosum, etc.
Chlamydia such as the adult or acute inclusion conjunctivitis, trachoma, and
Lymphogranuloma venereum and fungi such as Aspergillus, Candida, Nocadia,
Leptothrix, Sporothrix, Actinomyces, Rhinosporidium and protozoa like Toxoplasma and
Acanthamoeba are also implicated in causing ocular infections.1
Topical AMAs include antibacterial, antiviral, antichlamydial, antifungal and
antiprotozoal
agents.
Commonly
used
ocular
antibacterial
agents
include
chloramphenicol, ciprofloxacin, norfloxacin, ofloxacin, gatifloxacin, levofloxacin,
moxifloxacin, sparfloxacin, erythromycin, gentamicin, tobramycin, neomycin, amikacin,
sulfacetamide, tetracycline, bacitracin, and polymixin; antiviral agents include acyclovir,
idoxiuridine, vidarabine, trifluridine; and antifungal agents include amphoterecin B,
natamycin and miconazole.2
The efficacy of topical AMAs depends upon the susceptibility of the pathogens,
duration of contact, the local pharmacokinetics of the agent and the ability to penetrate
into deeper layers.3
The topical AMAs are administrated either as drops or ointments. Most of the
agents are instilled into the conjunctival sac as solutions, but those with limited solubility
may be used as suspensions. Gels and ointments provide the advantage of prolonging the
duration of contact with the conjunctival surface.2 Ocular bioavailability of AMAs may
be enhanced by the use of viscous vehicles such as hydroxypropyl-methylcellulose,
polyvinyl alcohol, polyvinyl pyrrolidone, hyaluronic acid and cyclodextrin.3 The
penetrability is increased in the presence of inflammation or epithelial damage.1
3
Indiscriminate use of topical AMAs may cause histological and ultrastructural
changes in the conjunctiva leading to decreased tear break-up and dry eye state,
interfering or delaying the healing process.4 Topical AMAs are also know to induce
hypersensivity reactions such as allergic conjunctivitis, contact dermatitis, StevensJohnsons syndrome, and punctuate keratopathy.5,6
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6.3
Objectives of the study
a.
To study the pattern of use of topical AMAs for superficial ocular infections and
the criteria for their selection.
b.
To assess their safety and tolerability.
c.
To evaluate the treatment outcome.
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7. Materials and methods
7.1
Source of data
Patients attending the Department of Ophthalmology, KIMS Hospital and
Research Centre, Bangalore.
7.2
Method of collection of data (including sampling procedure, if any)
A.
Methodology and type of data collected
After obtaining clearance and approval from the institutional ethics committee,
200 consecutive patients presenting with ocular infections will be included for the study.
Patients from all age groups of either sex, receiving topical AMAs either for prophylaxis
or treatment of ocular infections will be assessed for the pattern of use, safety and
tolerability and treatment outcome. Patients with deep ocular or periocular infections who
may need or receiving systemic antimicrobial therapy will not be included for the study.
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The written informed consent will be obtained from all the patients or their
guardians/legal representatives.
The following data will be recorded from all the study subjects:
a.
Demographic data
b.
Clinical data including laboratory data i.e., the type of infection, severity
and duration of infection, likely causative organism, underlined disease
state, investigation reports, etc.
c.
Drug history - current and past
The topical AMAs used during study, the intended purpose of use (prophylaxis or
treatment), the criteria for selection, type of formulation, the dose/strength, frequency and
duration of administration, tolerability and adverse reactions if any (local or systemic)
will be assessed. The outcome of the treatment will be evaluated, and any change in the
medication or the formulation will be recorded. Patient compliance will be assessed by
maintaining daily drug reminder chart.
B.
Inclusion criteria
Outpatients and inpatients from all age groups of either gender receiving topical
AMAs.
C.
Exclusion criteria
a.
Patients with deep ocular or periocular infections requiring or receiving
systemic antimicrobial therapy.
b.
Patients or their legal representatives not willing to give the written
informed consent.
D.
Sample size
200 or more
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E.
Sample design
Purposive sampling
F.
Study design
Descriptive and observational study
G.
Study period
January 2011 – June 2012 (18 months)
H.
Place of study
Department of Ophthalmology, KIMS Hospital and Research Center, Bangalore
I.
Statistical methods involved
The data collected will be analyzed statistically using descriptive statistics namely mean,
median and standard deviation for quantitative variables. Wherever necessary, the results
will be depicted in the form of percentages and graphs.
7.3
Does the study require any investigations or interventions to be conducted on
patients or other humans or animals? If so, please describe briefly.
Laboratory/bacteriological studies in selected cases, if found necessary.
It does not require animal studies.
7.4
Has ethical clearance been obtained from your institution in case of 7.3?
Yes.
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8. List of references
1.
Sihota R, Tandon R, editors. Parsons’ Diseases of the Eye. 20th Ed. Elsevier: Noida
(India); 2007. p.155-180.
2.
Henderer JD, Rapuano CJ; Ocular Pharmacology. In: Brunton LL, Lazo JS, Parker KL,
editors. Goodman & Gilman’s The Pharmacological Basis of Therapuetics. 11th Ed. New
York: McGraw-Hill Companies; 2006. p.1707-1737.
3.
John GR, Kaufman HE. Cornea and External Diseases. In: Zimmerman TJ, Kooner KS,
Sharir M, Fetchner RD, editors. Textbook of Ocular pharmacology. Philadephia:
Lippincott-Raven Publishers, 1997. p.471-472.
4.
Sood AK, Gupta A, Dabral T. Indiscriminate use of topical antibiotics; A menace. Indian
Journal of Ophthalmology: 1999:47 (2). p.121-124.
5.
Patalano SM, Hyndiuk RA. Aminoglycosides in Ophthalmology. In: Zimmerman TJ,
Kooner KS, Sharir M, Fetchner RD, editors. Textbook of Ocular Pharmacology.
Philadephia: Lippincott-Raven Publishers, 1997. p.531-535.
6.
Kelly LD. Antiparasitic Agents. In: Zimmerman TJ, Kooner KS, Sharir M, Fetchner RD,
editors. Textbook of Ocular Pharmacology. Philadephia: Lippincott-Raven Publishers,
1997. p.493-506.
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9. Signature of the candidate
______________________________________________________________________________
10. Remarks of the guide
The present study will be useful to generate valid data regarding the pattern of topical AMA
use in superficial ocular infections and also to formulate hospital policy and guidelines for
rational prescribing in ophthalmological practice.
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11. Name & designation of
11.1
Guide
Dr. H.P. PUNDARIKAKSHA
Professor and HOD
Department of Pharmacology
KIMS, Bangalore.
11.2
Signature
______________________________________________________________________________
11.3
Co-Guide (if any)
Dr. H.N.SOWBHAGYA,
Professor
Department of Ophthalmology
KIMS, Bangalore
11.4
Signature
________________________________________________________________________
11.5
Head of the department
Dr. H.P. PUNDARIKAKSHA
Professor and HOD
Department of Pharmacology
KIMS, Bangalore
11.6
Signature
________________________________________________________________________
12.
12.1
Remarks of Chairman & Principal
12.2
Signature
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