RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA
BANGALORE, KARNATAKA
ANNEXURE – II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1 / Name of the Candidate and Address (in Block Letters) / Dr. NIKHIL .V. NEGALURS/o Dr. VIJAY NEGALUR
A4, 501/502, VIKAS COMPLEX,
L.B.S ROAD, CASTLE MILL COMPOUND,
THANE (W) 400601. MUMBAI
MAHARASHTRA
2 / Name of the Institution / J.J.M. MEDICAL COLLEGE
DAVANGERE – 577 004, KARNATAKA
3 / Course of Study and Subject / MS - OPHTHALMOLOGY
4 / Date of Admission to Course / 31.05.2010
5 / Title of the Topic / “PREVALENCE OF DIABETIC RETINOPATHY IN TYPE II DIABETES IN RELATION TO RISK FACTORS- A HOSPITAL BASED STUDY”
6 / Brief Resume of the intended work:
6.1 Need for the study:
The prevalence of type 2 diabetes is known to be very high in the Indian subcontinent 1. Indian patients demonstrate certain distinct features i.e., onset at a younger age 2, a strong genetic predisposition 3,4 and less common obesity. 5
It is estimated that 79.4 million people in India will have Diabetes by the year 2030 6. The rapid increase in the number of persons with Diabetes is expected to lead to an increase in the number of persons with ocular complications of diabetes. Few studies have reported the magnitude and distribution of diabetic retinopathy (DR) in India7-10.
Diabetes mellitus (DM) is a major cause of avoidable blindness in both the developing and the developed countries. Patients with diabetic retinopathy (DR) are 25 times more likely to become blind than non-diabetics11-12. Studies of various complications in Indian diabetics is therefore of great interest and very few studies are available on the prevalence of diabetic retinopathy from India13.
This study aims to estimate the prevalence of Diabetic Retinopathy in type 2 diabetes and the possible risk factors associated with DR.
6.2 Review of Literature
A Study on Prevalence and risk factors of Diabetic Retinopathy conducted at Aravind Eye Institute in Dec 2009 showed that among the 25,969 persons screened for Diabetes Mellitus (DM), 2802 (10.8%) were found to have DM. Diabetic Retinopathy was detected in 298 (12.2%) of 2802 Diabetic subjects.14
A Cross-sectional study conducted in the United States from 2005 to 2008 to estimate the prevalence of Diabetic Retinopathy and its risk factors concluded that “the estimated prevalence of diabetic retinopathy and vision-threatening diabetic retinopathy was 28.5% and 4.4 % among US adults with diabetes respectively.” The male sex was independently associated with the presence of diabetic retinopathy as well as higher hemoglobin A1c level , longer duration of diabetes, insulin use and higher systolic blood pressure.15
A study on the Prevalence of DR in Type 2 Diabetics conducted in Switzerland concluded that “the prevalence of diabetic retinopathy was 38.4% in the studied population.” A direct relationship was established between diabetic retinopathy and diabetes mellitus evolution time (p<0.0001), renal damage (p<0.0001), insulin use (p<0.0001) and glycosylated hemoglobin change (p=0.003).16
A study on Prevalence of Diabetic Retinopathy in type 2 Diabetes conducted in S.P. Medical College, Bikaner from January 1999 to December 2000 highlighted the high prevalence of retinopathy in type 2 Diabetes in India. The study carried out on 4069 subjects showed evidence of retinopathy in 1176 patients (28.9%). This comprised of 938 cases (79.8%) of Non-Proliferative diabetic Retinopathy, 68 cases(5.8%) of Maculopathy and 172 cases (14.6%) of Proliferative Diabetic Retinopathy. Multiple logistic regression analysis showed that duration of Diabetes, Age of the patient, Systolic Blood Pressure and Glycosylated Hb had positive contributions.17
6.3 Objective of the Study:
1. To estimate the prevalence of Diabetic Retinopathy (DR) and the possible risk factors associated with DR
7. / MATERIALS AND METHOD
7.1 Source of Data
The materials for the present study will be drawn from patients attending the out patient department of Ophthalmology at Chigateri General Hospital and Bapuji Hospital attached to J.J.M Medical College, Davangere from November 2010 to September 2012.
7.2 Method of collection of Data (including sampling procedures if any)
The study will be undertaken in patients with Type 2 Diabetes who will be attending the out patient department of Ophthalmology or referred from Medicine out patient department during the study period.
A minimum of 100 cases with Type 2 Diabetes in CG hospital and Bapuji Hospital, Davangere will be selected for the study. A careful and detailed history will be taken regarding the duration and symptoms of the disease. Thorough systemic examination will be done. Investigations like routine blood, urine examination, FBS/PLBS and Lipid Profile will be done. This will be followed by an detailed Eye examination including:
§ Examination of adnexae and extraocular structures i.e the examination of face, orbits, eyebrows, eyelids, palpebral fissure, extraocular movements and lacrimal sac.
§ Examination of anterior segment by slit lamp biomicroscopy
§ Examination of the posterior segment by ophthalmoscopy (direct and indirect ) and +90D biomicroscopy.
§ Fundus Photography followed by Fluorescein Angiography (if required) will be undertaken for positive cases.
Recording of visual acuity and intraocular pressure (applanation) will be done.
Inclusion criteria:
§ All cases of type 2 Diabetes above the age of 40 years who will come to CG hospital and Bapuji Hospital, Davangere will be included in this study.
Exclusion Criteria:
Following patients will be excluded from the study:
§ Patients who are non-compliant.
§ Patients who are under 40 years of age
§ Pregnant and Lactating women
§ Immunocompromised patients
§ Patient with renal insufficiency and Cardiovascular Diseases
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.
§ Routine Blood Investigations
§ Urine Albumin, Sugar
§ Fasting and Post Prandial Blood Sugars
§ Lipid Profile
§ Glycosylated Hb
§ Renal Function tests
§ ECG
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
Yes
8. / LIST OF REFERENCE
1. Ramchandran A, Jali MV, Mohan V, Snehalatha C, Viswanathan M. Higher prevalence of diabetes in an urban population in South India. Br Med J 1988; 297: 587-90.
2. Mohan V, Ramchandran A, Snehalatha C, Mohan R, Bharani G, Viswanathan M. High Prevalence of maturity onset diabetes of the young (MODY) among Indians. Diabetes Care 1985; 8: 371-4.
3. Mohan V, Sharp PS, Aber V, Mather HM, Kohner EM. Family histories of Asian Indian and European NIDDM patients. Pract Diabetes (U.K.) 1986; 3: 254-6.
4. Viswanathan M, Mohan V, Snehalata C, Ramachandran A. High prevalence of type 2 (non insulin dependent) diabetes among offspring of conjugal type 2 diabetic patients in South India. Diabetologia 1985; 28: 907-10.
5. Ramchandran A, Snehalatha C, Dharmaraja D, Viswanathan M. Prevalence of glucose intolerance in Asian Indians. Diabetes Care 1992; 15: 1348-55.
6. Wild S, Roglic G, Green A et al. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care 2004; 27: 1047–53.
7. Dandona L, Dandona R, Naduvilath TJ, et al. Population based assessment of diabetic retinopathy in an urban population in southern India. Br J Ophthalmol 1999; 83: 937–40.
8. Rema M, Premkumar S, Anitha B, et al. Prevalence of diabetic retinopathy in urban India: The Chennai Urban Rural Epidemiology Study (CURES) Eye study, I. Invest Ophthalmol Vis Sci 2005; 46: 2328–33.
9. Dandona L, Dandona R, Naduvilath TJ, et al. Population based assessment of diabetic retinopathy in an urban population in southern India. Br J Ophthalmol 1999; 83: 937–40.
10. Rema M, Premkumar S, Anitha B, et al. Prevalence of diabetic retinopathy in urban India: The Chennai Urban Rural Epidemiology Study (CURES) Eye study, I. Invest Ophthalmol Vis Sci 2005; 46: 2328–33.
11. Singh R, Ramasamy K, Abraham C, Gupta V, Gupta A. Diabetic retinopathy: An update. Indian J Ophthalmol 2008; 56: 179-88.
12. National society to prevent blindness. In: Visual problems in the US data analysis definition, data sources, detailed data tables, analysis, interpretation. New York: National society to prevent blindness 1980: 1-46.
13. Rema M, Ponnaiya M, Mohan V. Diab Res Clin Pract 1996; 34: 29-36.
14. Namperumalsamy P, Kim R, Vignesh TP, Nithya N, Royes J, Gijo T, Thulasiraj RD, Vijayakumar V. Prevalence and Risk factors for Diabetic Retinopathy: A population based assessment from Theni District, South India. Postgrad Med J. 2009 Dec; 85(1010): 643-8.
15. Prevalence of Diabetic Retinopathy in the United States, 2005-2008
16. Zhang X, Saaddine JB, Chou CF, Cotch MF, Cheng YJ, Geiss LS, Gregg EW, Albright AL, Klein BEK, Klein R, JAMA.2010; 304(6): 649-656. doi: 10.1001/jama. 2010.1111.
17. Oftalmol AB. Prevalence of diabetic retinopathy in patients affected by type 2 diabetes mellitus in the city of Luzerna—SC 2010 Jun; 73(3): 259-65.
18. Jost BS, Hilgemberg E, Rodrigues EB, Daniotti AF, Bonamigo EL. Universidade do Oeste de Santa Catarina, Joaçaba, SC, Brasil. Prevalence of Diabetic Retinopathy in Type 2 Diabetes in Relation to Risk Factors: Hospital Based Study. Agrawal R P, Ranka M, Beniwal R, Gothwal S R, Jain G C, Kochar D K, Kothari R P 2003; 23(1): 16-19.
9. / Signature of the Candidate
10. / Remarks of the Guide / Recommended for submission
11. / Name & Designation
11.1 Guide
11.2 Signature / Dr. RAVINDRA BANAKAR M.S DOMS
PROFESSOR,
DEPARTMENT OF OPHTHALMOLOGY,
J.J.M MEDICAL COLLEGE,
DAVANGERE- 577004
11.3 Co-Guide (If any)
11.4 Signature
11.5 Head of the Department
11.6 Signature / Dr. S.V. RAVINDRANATH M.S DOMS
PROFESSOR AND H.O.D,
DEPARTMENT OF OPHTHALMOLOGY,
J.J.M MEDICAL COLLEGE,
DAVANGERE- 577004
12 / 12.1 Remarks of the Chairman & the Principal
12.2 Signature