Download rajiv gandhi university of health sciences, karnataka

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
KARNATAKA, BANGALORE.
ANNEXURE - II
PROFORMA FOR THE REGISTRATION OF SUBJECT FOR
DISSERTATION
1. NAME OF THE CANDIDATE
AND ADDRESS ( IN BLOCK
LETTERS )
DR.PRIYA.V.R.
POST-GRADUATE IN
OPHTHALMOLOGY,
DEPARTMENT OF OPHTHALMOLOGY,
MYSORE MEDICAL COLLEGE AND
RESEARCH INSTITUTE,
MYSORE - 570 001
2. NAME OF THE INSTITUTION MYSORE MEDICAL COLLEGE AND
RESEARCH INSTITUTE,
MYSORE - 570 001.
3. COURSE OF THE STUDY
AND SUBJECT
M.S.OPHTHALMOLOGY
4. DATE OF COMMENCEMENT
OF THE COURSE
31-05-2011
5. TITLE OF THE TOPIC
“A COMPARATIVE STUDY TO
EVALUATE THE OUTCOME OF
FIBRIN GLUE VERSUS SUTURES IN
CONJUNCTIVAL AUTOGRAFT FOR
PRIMARY PTERYGIUM EXCISION”
6.
BRIEF RESUME OF THE INTENDED WORK
6.1
NEED FOR THE STUDY
Pterygium is a triangular fibrovascular subepithelial ingrowth of degenerative
bulbar conjunctival tissue over the limbus onto the cornea1.
The various surgical techniques developed for its treatment are bare
sclera technique, conjunctival autografting (currently most popular approach),
2
adjunctive treatment with mitomycin C or beta-irradiation, amniotic membrane
patch grafting1, 2. Compared with other techniques, conjunctival autografting after
pterygium excision is associated with lower rates of recurrence and complications.
Nevertheless graft suturing has disadvantage of longer surgery time and complications
like granuloma formation, giant papillary conjunctivitis and significant patient
discomfort 3.
Lately fibrin based glues for conjunctival autograting have been used to
minimize operating time and discomfort associated with sutures 2.
Compared to developed countries, studies comparing outcome of fibrin glue
and sutures have been fewer in India. Since it will be advantageous to adopt the better
of the two techniques in the future, an attempt is being made in this dissertation to
compare the two techniques at K.R. Hospital, Mysore.
6.2
REVIEW OF LITERATURE
A number of recent developments have established tissue adhesives as an
attractive alternative to suturing. Currently, tissue adhesives are being used for
conjunctival closure following pterygium and strabismus surgery, forniceal
reconstruction surgery, amniotic membrane transplantation, lamellar corneal grafting,
closure of corneal perforations and descemetoceles, management of conjunctival
wound leaks after trabeculectomy, lid surgery, adnexal surgery and as a hemostat to
minimize bleeding. The two basic categories of tissue adhesives are – synthetic
(commonest is n-butyl-2-cyanoacrylate) and biological (fibrin glue). Fibrin glue is a
blood derived product that is absorbable, relatively easy to use, and can be kept at
room temperature or in a refrigerator 4.
3
Karalezli et al compared the use of fibrin glue versus sutures for fixating
conjunctival autografts in 50 patients undergoing pterygium excision. In the
fibrin glue group (n=25) mean operation time was 15.7 minutes and in suture group
(n=25) it was 32.5 minutes (p< 0.001). The intensity of postoperative pain, foreign
body sensation, irritation and epiphora were significantly lower in fibrin glue group
(p<0.001). The intensity of itchy sensation at the first 2 post operative visits was
lower among fibrin glue group (p<0.05).At the end of follow-up of 12 months,
pterygium recurrence was observed in one eye (4%) in fibrin glue group and in three
eyes (12%) in suture group (p<0.05) 3.
Srinivasan
et
al
compared
the
degree
of
conjunctival
autograft
inflammation, subconjunctival haemorrhage (SCH) and graft stability following
the use of sutures or fibrin flue (FG) during pterygium surgery in 40 eyes. The degree
of inflammation was significantly less with FG than with sutures at 1 month
(p=0.019) and 3 months (p=0.001) postoperatively. Grafts were equally stable. No
significant difference was found in degree of post operative SCH between the
groups. Rubbing the eye can cause graft dehiscence following pterygium surgery
with fibrin glue 5.
Farid et al conducted retrospective study to evaluate rate of recurrence
after pterygium excision with autograft in 47 eyes. Tissue adhesive had been used in
27 eyes and sutures in 20 eyes. Post-operative courses followed for 22-36 months.
Recurrence rate in tissue adhesive group was 3.7% compared to 20% in suture group
(p=0.035). Recurrence rate in tissue adhesive group was comparable to previously
reported rates for sutures in the literature 6.
4
Bahar et al compared long-term results of conjunctival closure with
fibrin adhesive (n=42) or vicryl sutures (n=39) in 81 eyes with primary nasal
pterygium and followed up for 1 year - Surgery in all patients consisted of
bare sclera technique combined with intraoperative mitomycin C 0.02%
administration. There were no complications in glue group, one patient in suture
group had a medically treatable corneal dellen. At the end of follow-up,
recurrent pterygium developed in 11.9 % eyes of fibrin glue group and in 7.7% eyes
of vicryl suture group (p <0.05) 7.
Marticorena et al evaluated the efficiency and safety of using fibrin
adhesive to avoid need for sutures during conjunctival autograft surgery for
primary pterygium in 20 eyes. The time of surgery was 15-20 minutes. During
postoperative course, none felt pain, only 25% had mild sensation of presence of
foreign body. In 90 % of patients, autograft was correctly fixed in follow-up exams.
No case of recurrence of pterygium was noted 8.
Uy et al compared the efficacy and safety of conjunctival autografting with
fibrin glue (n=11) and suturing (n=11) among 22 patients undergoing pterygium
excision. Patients were followed up for 2 months. All autografts were successfully
attached and intact after 2 months. Average operating time for fibrin glue group was
significantly shorter (p< 0.001). Postoperative symptoms were fewer for fibrin glue
group 9.
Koranyi et al carried out a trial in 43 eyes with primary nasal pterygium.
Autograft attached with fibrin tissue adhesive in 20 eyes and sutures in 23
eyes. Average pain was significantly lower in glue group p < 0.05. Average
5
surgery time was 9.7 minutes for glue and 18.5 minutes for sutures, p < 0.001. No
complications occurred 10.
6.3
OBJECTIVES OF THE STUDY
1.
To compare the duration of surgery, postoperative complications and patient
comfort between the use of fibrin glue versus sutures for fixating conjunctival
autografts after primary pterygium excision.
2.
To compare the recurrence of pterygium in the two methods at the end of 6
months of follow-up.
7
MATERIALS AND METHODS
7.1
SOURCE OF DATA
Patients with primary nasal pterygium who fulfill the inclusion and
exclusion criteria, attending the outpatient department at K.R.Hospital, Mysore during
the study period.
7.2
METHOD OF DATA COLLECTION
Sample Size: 80 patients.
Sampling Method: Simple random sampling.
Inclusion Criteria:
-
Patients with primary nasal pterygium consenting for surgery and with any of
following indications for surgery – encroachment upon visual axis, inducing
visually significant astigmatism, causing recurrent irritation or cosmetically
bothersome to the patient.
-
Patients older than 18 years.
6
Exclusion Criteria:
-
Temporal pterygium
-
Recurrent pterygium
-
Atrophic pterygium
-
Patients on anticoagulants
-
Patients with pre-existing glaucoma
-
Patients with immune system disease, eyelid or ocular surface diseases egblepharitis, sjogren syndrome and dry eye.
-
History of previous ocular surgery or trauma.
Method of study
Data will be collected using a piloted proforma meeting the objectives of the
study by means of personal interview with the patients, after informed consent.
Patients fulfilling the inclusion and exclusion criteria will be taken. Routine
ophthalmic examinations including visual acuity, slit lamp examination, fundus
evaluation and keratometry readings will be taken in all patients. 40 patients will
undergo pterygium excision with conjunctival autografting using fibrin glue and
40 patients will undergo pterygium excision with conjunctival autografting using
10-0 nylon sutures. The following parameters will be anlaysed - duration of surgery,
subconjunctival haemorrhage, inflammation, graft stability, degree of discomfort,
recurrence at the end of six months. Post operatively all patients will be followed up
on 1st day, one week, one month, three months, six months and the above said
parameters will be compared.
7
Statistical Method Used :
Descriptive statistics, ‘t’ test - independent samples and paired samples,
chi-square test, repeated measure ANOVA using SPSS for windows software.
7.3
Does the study require any investigation/ intervention to be conducted on
patients or any other human beings or animals ? If so, describe briefly.
Yes.
Surgical intervention needed. Excision of pterygium followed by conjunctival
autografting using either 10-0 nylon sutures or fibrin glue.
7.4
HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR
INSTITUTION?
Yes, copy enclosed.
7.5
DURATION OF THE STUDY: December 2011 – July 2013.
8
8
LIST OF REFERENCES
1.
Kanski JJ, Bowling B.Clinical Ophthalmology: A Systematic approach. 7th ed.
Elsevier ; 2011: p163.
2.
Farjo QA, Sugar A. Pterygium and conjunctival degenerations. In : Yanoff M,
Duker JS. Ophthalmology. 3rd ed. Mosby Elsevier; 2009: p249.
3.
Karalezli A, Kucukerdonmez C, Akova YA, Altan - Yaycioglu R, Borazan M.
Fibrin glue versus sutures for conjunctival autografting in pterygium surgery: a
prospective comparative study. Br J Ophthalmol. 2008 ; 92(9) : 1206 - 10.
4.
Panda A, Kumar S, Kumar A, Bansal R, Bhartiya S. Fibrin glue in
Ophthalmology. Indian J Ophthalmol. 2009;57:371-9.
5.
Srinivasan S, Dollin M, McAllum P, Serger Y. Fibrin glue versus sutures for
attaching the conjunctival autograft in pterygium surgery : a prospective
observer masked clinical trial. Br J Ophthalmol. 2009 ; 93(2): 215-18.
6.
Farid
M,
Pirnazar
JR.
Pterygium
recurrence
after
excision
with
conjunctival autograft - a comparison of fibrin tissue adhesive to
absorbable sutures. Cornea 2009 Jan ; 28(1): 43-5.
7.
Bahar I, Weinberger D, Gaton D D Avisar R. Fibrin glue versus vicryl sutures
for primary conjunctival closure in pterygium surgery : Long term results.
Current Eye Research 2007;32(5): 399-405.
8.
Marticorena J, Rodriguez - Ares MT, Tourino R, Mera P. Pterygium Surgery:
Conjunctival Autograft using a fibrin adhesive. Cornea 2006; 25(1): 34-6.
9
9.
Uy HS, Reyes JMG, Flores JDG, Lim-Bon-Siong R. Comparison of fibrin glue
and sutures for attaching conjunctival autografts after pterygium excision.
Ophthalmology 2005;112(4): 667-71.
10.
Koranyi G, Seregard S, Kopp ED. Cut and paste: a no suture, small incision
approach to pterygium surgery. Br J Ophthalmol. 2004;88:911-14.
10
9.
10.
11.
SIGNATURE OF
THE CANDIDATE
:
DR. PRIYA.V.R
REMARKS OF THE
GUIDE
:
NAME AND
DESIGNATION OF
:
11.1
GUIDE
: DR. SATISH. K, M.S
ASSOCIATE PROFESSOR,
DEPARTMENT OF OPHTHALMOLOGY
MYSORE MEDICAL COLLEGE AND
RESEARCH INSTITUTE,
MYSORE.
11.2
SIGNATURE
:
11.3
HEAD OF THE
DEPARTMENT
: DR. H.T.VENKATE GOWDA, M.S, D.O.M.S
PROFESSOR AND HEAD,
DEPARTMENT OF OPHTHALMOLOGY
MYSORE MEDICAL COLLEGE AND
RESEARCH INSTITUTE,
MYSORE.
11.4
SIGNATURE
:
12.1
REMARKS OF THE
DEAN AND DIRECTOR
:
SIGNATURE
:
12.2
11
ETHICAL COMMITTEE CLEARANCE
1. TITLE OF DISSERTATION
: A COMPARATIVE STUDY TO
EVALUATE THE OUTCOME OF FIBRIN
GLUE VERSUS SUTURES IN
CONJUNCTIVAL AUTOGRAFT FOR
PRIMARY PTERYGIUM EXCISION.
2. NAME OF THE CANDIDATE
: DR. PRIYA.V.R
3. SUBJECT
: M.S. OPHTHALMOLOGY
4. NAME OF THE GUIDE
: DR. SATISH. K, M.S
ASSOCIATE PROFESSOR,
DEPARTMENT OF OPHTHALMOLOGY,
MYSORE MEDICAL COLLEGE AND
RESEARCH INSTITUTE,
MYSORE.
5. APPROVED/
NOT APPROVED
: APPROVED
12
MEDICAL SUPERINTENDENT
K R HOSPITAL
MYSORE
MEDICAL SUPERINTENDENT
CHELUVAMBA HOSPITAL
MYSORE
PROFESSOR AND HOD
DEPT OF MEDICINE
MMC&RI
MYSORE
PROFESSOR AND HOD
DEPT OF SURGERY
MMC&RI
MYSORE
SUPERINTENDENT
PKTB HOSPITAL
MYSORE
LAW EXPERT
DIRECTOR AND DEAN
MMC&RI, MYSORE.