RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA BANGALORE

“ANNEXURE – II”

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1 /
Name of the Candidate
and Address
(in Block Letters) / Dr. G. BHARATH REDDY
S/O G. SIVA REDDY,
S.R.B.C. COLONY,
KARIVENA POST,
ATMAKURU TALUK,
KURNOOL DISTRICT,
ANDHRAPRADESH.
2 /
Name of the Institution
/ J.J.M. MEDICAL COLLEGE,
DAVANGERE – 577 004.
3 / Course of the Study and Subject / POSTGRADUATE
M.D. IN PEDIATRICS
4 / Date of Admission to Course / 12-05-2010
5 /
Title of the Topic
/ “RETINOPATHY OF PREMATURITY IN A TERTIARYCARE HOSPITAL: INCIDENCE, RISK FACTORS AND OUTCOME”
6. / BRIEF RESUME OF THE INTENDED WORK
6.1 Need for the Study:
Retinopathy of prematurity (ROP) is a disease process mostly reported in preterm neonates with a wide spectrum, ranging from mild, transient changes in the retina with regression to severe progressive vasoproliferation, scarring, detachment of retina and blindness.1
The outlook and survival of preterm and low birth weight babies have very much improved in tertiary care hospitals due to provision of better facilities. There is much scope to improve the quality of life of these babies with treatment and follow up. Due to paucity of data and fewer studies done in tertiary care hospitals in this part of the country, I intend to do a study on “Incidence, risk factors and outcome of retinopathy of prematurity” with an aim to improve quality of life of these babies.
6.2 Review of Literature:
Studies have shown that the incidence of ROP in India varies from 38-51.9% among low birth weight babies. New born infants with birth weight less than 1500 gms and gestational age below 34 weeks constitute about 1.9% of the total live births in a tertiary care neonatal care unit.2
Chaudhari S. in 2009 undertook a study of 552 babies using the screening criteria ≤32 weeks gestational age or birth weight<1500 gms or additional risk factors and reported the incidence of ROP and threshold ROP to be 22.3% (123/552) and 7.4% (41/552) respectively.1
Charan R. in 1995 using the screening criteria-birth weight ≤ 1700 gms among babies admitted to the neonatal unit reported the incidence of ROP -47 %.3
Binkhathlan A.A., Almahmoud L.A., Salesh M.J., Srungeri S. in a study from Saudi Arabia reported 56% incidence; 15 % of these patients were in stage of the severe disease (severe ROP). The mean Gestational age was 30 weeks for the ROP positive group. The most significant risk factor for the development of ROP was Gestational age.4
RISK FACTORS FOR ROP : Prematurity
Low Birth Weight
Oxygen therapy
Seizures
Ventilation
Exchange Transfusion
Blood products use
Hyperbilrubinemia
PDA
Apnea
Septicemia
CPAP

Fig. 1. International classification of Retinopathy of prematurity (ICROP) zones.5

CLASSIFICATION OF ROP :

1 / Location / Zone I / Circle with optic nerve at centre and a radius of twice the distance from optic nerve to macula
Zone II / From edge of Zone I to the nasal oraserrata nasally and equator temporally
Zone III / Lateral most crescent shaped area from Zone II to ora-serrata temporally
2 / Severity / Stage 1 / Presence of thin white demarcation line separating the vascular from avascular retina
Stage 2 / The line becomes prominent because of lifting of retina to form a ridge having height and width
Stage 3 / Presence of extra retinal fibro-vascular proliferation with abnormal vessels and fibrous tissue arising from the ridge and extending into vitreous
Stage 4 / Partial retinal detachment; not involving macula (4A) or involving macula (4B)
Stage 5 / Complete retinal detachment
3 / Plus disease / Presence of dilatation and tortuosity of posterior retinal vessels, associated with vitreous haze, pupillary rigidity.
4 / Extent / Extent of involvement of the retina is expressed as clock hours (30 degree sectors)
5 / Pre-plus disease / Vascular abnormalities of the posterior pole that are insufficient for the diagnosis of plus disease but that demonstrate more arterial tortuosity and more venous dilatation than normal.
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8 / TREATMENT :
Early Treatment of Retinopathy of Prematurity:
Type 1 ROP : Zone I, any stage ROP with plus disease
Zone I, stage 3 ROP with or without plus disease
Zone II, stage 2 or 3 ROP with plus disease
Type 2 ROP : Zone I, stage 1 or 2 ROP without plus disease
Zone II, stage 3 ROP without plus disease
Peripheral retinal ablation should be carried out for all cases with type 1 ROP and continued serial examinations are advised for type 2 ROP.
6.3 Objectives of the study:
To know the incidence, risk factors and outcome of ROP in level 3
neonatal care centre.
Material and Methods:
7.1 Source of Data :
Babies of gestational age ≤ 36 weeks and birthweight ≤ 1500 gms OR babies of birth weight between 1500 and 17000 gms with other risk factors admitted to JJM Medical College attached Hospitals.
• Chigateri General Hospital, Davangere
• Bapuji Child Health Institute and Research Centre, Davangere
• Women and Children Hospital, Davangere
7.2 Method of Collection Data
Inclusion criteria:
Babies born at ≤ 34 weeks of gestational age.
Babies born with birth weight ≤ 1500 gms.
Babies born with birth weight 1500-1700 gms and presence of
other risk factors.
Exclusion criteria:
Babies born at 34 weeks of gestational age.
Sample Size and Design :
Initially, a minimum of 100 at risk babies are intended to be screened and followed up as part of the study. However, the scope for expanding the sample size exists depending on statistical requirements.
Method of Examination:
All the babies satisfying the above mentioned inclusion criteria will be screened with RETCAM by expert visiting ophthalmologist (from Bangalore) and the results will be available the following day and these babies will be followed up for a period of six months on a regular basis. Babies who are found to have Retinopathy Of Prematurity will be treated appropriately, and followed up.
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.
Yes. All at risk babies will undergo screening with RETCAM.
7.4 Has ethical clearance been obtained from your Institution in case of 7.3 ?
Yes.
List of references :
1.  Chaudhari S, Patwardhan V, Vaidya U, Kadam S, Kamat A. Retinopathy of prematurity in a tertiary care center-incidence,risk factors and outcome. Indian Pediatr. 2009 March 17;46:219.
2.  Varughese S, Jain S, Gupta N , Singh S, Tyagi V, Puliyel J.M. Magnitude of the problem of retinopathy of prematurity. Experience in a large maternity unit with a medium size level-3 nursery. Indian J Ophthalmol. 2001; 49(3):187-188.
3.  Charan R, Dogra MR, Gupta A, Narang A. The incidence of retinopathy of prematurity in a neonatal care unit. Indian J Ophthalmol. 1995; 43:123-6.
4.  Binkhathlan A.A, Almahmoud L.A, Saleh M.J, Srungeri S. Retinopathy of prematurity in Saudi Arabia:incidence,risk factors, and the applicability of current screening criteria. Br J Ophthalmol. 2008;92:167-169
5.  Ben-Sira I, Deutman A, Fledelius H, Flynn J, Garner A, Gole G. et al. An international classification of Retinopathy Of Prematurity. Arch Ophthalmol. 1984; 102:1130-1134.
9 / Signature of Candidate
10 / Remarks of the Guide / This study helps in the prevention of one of the preventable cause of blindness in children.
11 / Name and Designation of
(in block letters)
11.1 Guide
11.2 Signature
11.3 Co-Guide
11.4 Signature
11.5 Head of Department
11.6 Signature / Dr. M. B. KOUJALGI
M.D., (Ped.,)
PROFESSOR,
DEPARTMENT OF PEDIATRICS,
J.J.M. MEDICAL COLLEGE,
DAVANGERE – 577 004.
Dr.G.GURUPRASAD
M.D.,D.M.(NEONATALOGY)
PROFESSOR,
DEPARTMENT OF PEDIATRICS,
J.J.M. MEDICAL COLLEGE,
DAVANGERE – 577 004.
Dr. M.L. KULKARNI,
M.D.,F.I.A.P.,F.A.M.S,F.I.M.S.A., F.C.P.C.C.(Lon),
F.R.C.P.H (U.K), M.N.A.S.(NY)
PROFESSOR AND HEAD,
DEPARTMENT OF PEDIATRICS,
J.J.M. MEDICAL COLLEGE,
DAVANGERE – 577 004.
12 / 12.1 Remarks of the
Chairman and Principal
12.2 Signature

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