PROTOCOL

MS OPHTHALMOLOGY
GMC HALDWANI
H.N.B. MEDICAL EDUCATION UNIVERSITY, DEHRADUN

SESSION 2017-2020

THESIS TITLE

BURDEN OF OCULAR MANIFESTATIONS IN PATIENTS OF

RHEUMATOID ARTHRITIS IN TERTIARY CARE CENTRE OF KUMAON
REGION, UTTARAKHAND

STUDENT - DR. SMRITI CHIKARA

GUIDE – DR. VIMLESH SHARMA

ASSISTANT PROFESSOR
DEPARTMENT OF OPHTHALMOLOGY
GMC HALDWANI, NAINITAL
UTTARAKHAND

CO-GUIDE - DR. PARAMJEET SINGH

ASSOCIATE PROFESSOR
DEPARTMENT OF GENERAL MEDICINE
GMC HALDWANI, NAINITAL
UTTARAKHAND
APPLICATION FORM FOR APPROVAL OF PLAN OF THESIS FOR MS OPHTHALMOLOGY

1. Name of the candidate DR.SMRITI CHIKARA

2. Name of University from which SHRI GURU RAM RAI INSTITUTE OF MEDICAL
graduated & HEALTH SCIENCES, DEHRADUN
H.N.B.GARHWAL UNIVERSITY
SRINAGAR, PAURI GARHWAL, UTTARAKHAND
3. Date of joining M.S. course 12 JUNE 2017

4. Likely date of appearing MAY/JUNE, 2020

5. Proposed subject of thesis BURDEN OF OCULAR MANIFESTATIONS IN

PATIENTS OF RHEUMATOID ARTHRITIS IN
TERTIARY CARE CENTRE OF KUMAON REGION
UTTRAKHAND

6. Facilities for work on the subject of ADEQUATE FACILITIES ARE AVAILABLE IN

thesis DEPARTMENT OF OPHTHALMOLOGY, GOVT
MEDICAL COLLEGE AND ASSOCIATED DR.
SUSHEELA TIWARI MEMORIAL HOSPITAL,
HALDWANI (U.K)
7. Detailed scheme according to PROPOSAL ATTACHED
which the candidate proposes to
work
8. Name of Guide DR. VIMLESH SHARMA
ASSISTANT PROFESSOR
DEPARTMENT OF OPHTHALMOLOGY
GMC HALDWANI, NAINITAL
UTTARAKHAND

9. Name of Co-Guide DR. PARAMJEET SINGH

ASSOCIATE PROFESSOR
DEPARTMENT OF MEDICINE
GMC HALDWANI, NAINITAL
UTTARAKHAND
 ACKNOWLEDGEMENT LETTER

IEC has received research proposal entitled

“BURDEN OF OCULAR MANIFESTATIONS IN PATIENTS OF RHEUMATOID

ARTHRITIS IN TERTIARY CARE CENTER OF KUMAON REGION
UTTARAKHAND”

Registration number of the above research proposal is

_______________________.

Member Secretary
MEMBERS OF THESIS/RESEARCH SIGNATURE WITH STAMP
COMMITTEE

Head of the institute/college

Chairman of ethical committee

Member ethical committee

Member ethical committee

Member ethical committee

Member ethical committee

Member ethical committee

Member ethical committee

OBSERVATION BY ETHICAL COMMITTEE: ……………………..

DATE: SIGNATURE OF SECRETARY ETHICAL COMMITTEE

1. Title of the Project
2. Name of the chief investigator &
department
3. Name of co-investigator(s) & department
4. Objective of the study
5. Justification for conduct of study
6. Methodology
BURDEN OF OCULAR MANIFESTATIONS IN
PATIENTS OF RHEUMATOID ARTHRITIS IN
TERTIARY CARE CENTE OF KUMAON REGION
UTTRAKHAND
DR. VIMLESH SHARMA
ASSISTANT PROFESSOR
DEPARTMENT OF OPHTHALMOLOGY
GMC HALDWANI, NAINITAL
UTTARAKHAND
DR. PARAMJEET SINGH
ASSOCIATE PROFESSOR
DEPARTMENT OF MEDICINE
GMC HALDWANI, NAINITAL
UTTARAKHAND
TO IDENTIFY THE PATIENTS WITH OCULAR
INVOLVEMENT IN DIAGNOSED CASES OF
RHEUMATOID ARTHRITIS REFFERED FROM
RHEUMATOLOGY OPD TO EYE OPD OF DR.
SUSHEELA TIWARI MEMORIAL HOSPITAL,
HALDWANI
TO ENSURE EARLY IDENTIFICATION OF
OCULAR INVOLVEMENT IN DIAGNOSED
PATIENTS OF RHEUMATOID ARTHRITIS THUS
TO HELP ALLLEVIATE THE PROBLEMS OF
VISUAL IMPAIRMENT AND BLINDNESS.
PLACE OF STUDY -
Eye OPD
Department of ophthalmology
Dr. Susheela Tiwari Memorial Govt. Hospital
GMC Haldwani
INCLUSION CRITERIA:
All the diagnosed cases of RA (according to American
College of Rheumatology (ACR)/European League
against Rheumatism (EULAR) (2009) Classification
Criteria for Rheumatoid Arthritis , attending
 ophthalmology outpatient department will be included.

EXCLUSION CRITERIA:

 Patients with pre-existing ocular manifestations

uveitis, scleritis, glaucoma due to causes other
than RA will be excluded from the study.

 Ocular manifestations due to other systemic and

autoimmune diseases such as Reiter’s,
Ankylosing spondylitis ,psoriatic arthritis .

METHOD
Patients included in the study will be evaluated and a
detailed history and examination will be done:

History
The demographic details of the patients will be recorded.
In all cases, a detailed history will be taken pertaining to
 Duration of RA
 Systemic manifestations of RA
 Drug use and duration of treatment
 Family history of RA
 Symptoms pertaining to ocular manifestations

Ocular Examination
It will include
 Best corrected visual acuity
 Testing for color vision
 Amsler’s grid
 Slit lamp examination of anterior segment
 Detailed fundus examination
 Intraocular pressure measurement
 Tests for dry eyes
 Visual fields and B-scan if necessary were
performed
 Spectral domain optical coherence topography
where required.

7. Ethical issue involved in study NIL

8. Permission from drug controller General of NA

India, if applicable
9. Whether consent form in local language is NA
enclosed

10. Conflict of interest for any other NA

investigator, if any

Signature of investigator
 HUMAN ETHICS COMMITTEE APPROVAL

The members of IEC met on________ at GMC Haldwani and reviewed the

Project entitled

“BURDEN OF OCULAR MANIFESTATIONS IN PATIENTS OF

RHEUMATOID ARTHRITIS IN TERTIARY CARE CENTRE OF
KUMAON REGION UTTARAKHAND”

The IEC after careful deliberation has granted approval to the project.

This approval is valid for three years or the duration of project whichever
is earlier.

Member secretary

IEC, GMC, Haldwani

 DEPARTMENT OF OPHTHALMOLOGY GOVERNMENT MEDICAL COLLEGE AND DR.
SUSHILA TIWARI GOVT. HOSPITAL HALDWANI (U.K)

PROTOCOL FOR SUBMISSION OF PLAN OF THESIS FOR THE AWARD OF M.S.

OPHTHALMOLOGY, H.N.B. MEDICAL EDUCATION UNIVERSITY (UK) SESSION 2017-2020

NAME OF STUDENT : DR. SMRITI CHIKARA

NAME OF GUIDE : DR. VIMLESH SHARMA

ASSISTANT PROFESSOR
DEPARTMENT OF OPHTHALMOLOGY
GMC HALDWANI, NAINITAL
UTTARAKHAND

NAME OF CO- GUIDE : DR. PARAMJEET SINGH

ASSOCIATE PROFESSOR
DEPARTMENT OF MEDICINE
GMC HALDWANI, NAINITAL
UTTARAKHAND
 TITLE OF THESIS

BURDEN OF OCULAR MANIFESTATIONS IN PATIENTS OF RHEUMATOID

ARTHRITIS IN TERTIARY CARE CENTER OF KUMAON REGION
UTTARAKHAND

INTRODUCTION

Rheumatoid arthritis (RA) is a systemic inflammatory disease, which is associated with a number of extra-
articular organ manifestations, such as pericarditis, pleuritis, major cutaneous vasculitis, Felty’s syndrome,
neuropathy, ocular manifestations, glomerulonephritis, and other types of vasculitis
Extra-articular manifestation in RA are present in (10-20%) of patients which are more frequent in seropositive
patients.

More than half of the patients (52%) had ocular manifestations, out of which dry eye was the most common
manifestation (90%). Dry eyes are directly related to duration of disease than the severity. Ocular
manifestations of RA Include keratoconjunctivitis sicca (dry eye syndrome), episcleritis (episcleral nodulosis),
scleritis, scleromalacia perforans, peripheral ulcerative keratitis, corneal filamentary keratitis, exudative retinal
detachment, disc and macular edema due to posterior scleritis, retinal vasculitis and Brown’s syndrome. Of
these, keratoconjunctivitis sicca is the most common manifestation but it does not correlates with the disease
activity. Then followed by episcleritis and scleritis which shows correlation with the disease activity.

These ocular conditions are not specific to RA, but RA is their leading cause, ahead of systemic vasculitis. If
these ocular diseases are not promptly addressed, there is a high potential for patients to suffer permanent
damage and blindness. We emphasize the need for collaborative efforts between ophthalmologists and
rheumatologists when evaluating and treating patients with RA.

RA is usually more common in women with a ratio of 3:1 and disease onset is seen more common in fourth and
fifth decades of life. Ocular manifestations are common.
 REVIEW OF LITERATURE

Charanya et al., ocular manifestation in rheumatoid arthritis, study shows more than half of the patients (52%)
had ocular manifestations out of which dry eye was the most common manifestation(90%)

Reddy et al., study shows that 13 out of 100 patients of RA 39% were found to have eye involvement.10 The
prevalence
of different ocular manifestations in this arthritis has been reported differently in different studies. the previous
study showed only 37.28% complained of ocular symptom.

Moss et al., studied 3,722 individuals and found that 14.4% of patients had dry eyes. Females had more
incidence
of dry eye (16.7%) compared to males (11.4%). They concluded that the risk factor for developing dry eye was
arthritis which was followed by gout

.
KCS or dry eye is the most common ocular manifestation of RA with reported prevalence of 15-25%.

Watson and Hayreh did a 10 years study of 207 episcleritis and 159 scleritis patients.12,13 RA was seen in 28
patients in there study group. Seven had out episcleritis, eight with diffuse anterior scleritis, four with nodular
anterior scleritis, three with necrotizing scleritis, and six with scleromalacia perforans.

Jabs et al., studied 134 patients with scleral inflammation over a 12-year period.14 134 patients were studied
and 37 patients had episcleritis and 97 had scleritis. Systemic rheumatic disease was seen in 30% with episleritis
and 39.2% with scleritis. The rheumatic disease most common associated with scleral inflammation was RA.

McGavin et al., did a study on 4210 patients with RA and results showed that 7 patients had episcleritis 28
patients had scleritis. Similarly, they found coexistent posterior scleritis was more common in rheumatoid
scleritis (22.2%) than in nonrheumatoid scleritis (5.6%).

Cases of glaucoma secondary to scleritis and episcleritis have been reported in different studies.
 AIMS AND OBJECTIVES
AIM
The aim of this study is to measure the burden of ocular manifestation in patients of rheumatoid arthritis visiting
Dept. of Ophthalmology, GMC Haldwani.

OBJECTIVES
 To identify the patients with ocular involvement (whether asymptomatic or symptomatic) in diagnosed cases of
rheumatoid arthritis.
 To study the treatable and non-treatable ocular symptoms.
 To study various risk factors associated with ocular manifestations.

MATERIALS AND METHODS

The patients presenting in rheumatology OPD and diagnosed as having rheumatoid arthritis will be evaluated.

CONSENT AND ETHICS-

Informed written consent will be taken from patients participating in study and ethical clearance will be taken
from institutional ethical committee GMC Haldwani .

PLACE OF STUDY -
The data will be collected after taking proper history and detailed clinical examination of patients attending
Eye OPD, Department of ophthalmology, Dr. Susheela Tiwari Memorial Govt. Hospital,
GMC Haldwani.

SOURCE OF STUDY-
The study will be conducted in all the referred patients from rheumatology OPD to eye OPD, GMC Haldwani.

STUDY DESIGN-
A cross-sectional study. To assess the burden of ocular problems in patients with diagnosed RA in tertiary care
centre of kumaon region UK.

PATEINT SELECTION-
The study population will be diagnosed cases of rheumatoid arthritis visiting department of ophthalmology
reffered from rheumatology OPD.
SAMPLE SIZE-
The sample is calculated using the formula n = 4pq ( where p=prevalence, q=100-prevalance,
l2 l=allowable error )
Assuming the prevalence of ocular problems in patients of rheumatoid arthritis to be 52% reference from
(C Charanya, Achanti Swathi, Siddharam Janti, R Pandurangan , Post-graduate, Department of Ophthalmology, Chettinad Hospitals and Research
Institute, Chennai, Tamil Nadu, India, Associate Professor, Department of Ophthalmology, Chettinad Hospitals and Research Institute, Chennai, Tamil Nadu, India,
Professor and Head, Department of Ophthalmology, Chettinad Hospitals and Research Institute, Chennai, Tamil Nadu, India )
p = 0.52
q = 0.48
Absolute error = 10% , Alpha error = 0.10
According to the calculations the sample size comes to be 96

STUDY PERIOD- November 2017-2019

INCLUSION CRITERIA:

All the diagnosed cases of RA according to criteria ( American College of Rheumatology (ACR)/European
League against Rheumatism (EULAR) (2009) Classification Criteria for Rheumatoid Arthritis

Symptom Duration (as reported by patient) Points

 < 6 weeks 0
 > 6 weeks 1

Joint Distribution Points

 1 large joint 0
 2-10 large joints 1
 1-3 small joints (with or without involvement of large joints) 2
 4-10 small joints (with or without involvement of large joints) 3
 > 10 joints (at least 1 small joint) 5

Serology Points

 RF- and CCP- 0

 Low RF+ or CCP+ 2
 High RF+ or CCP+ 3

Acute Phase Reactants Points

 Normal ESR or CRP 0

 Abnormal ESR or CRP 1

RF: rheumatoid factor, CCP: anti-citrullinated citric peptide, ESR: erythrocyte sedimentation rate, CRP: C-
reactive protein, Low: < 3 x upper limit of normal (ULN), High: > 3 x ULN
attending ophthalmology outpatient department will be included.

EXCLUSION CRITERIA:

 Patients with pre-existing ocular manifestations uveitis, scleritis, glaucoma due to causes other than RA
will be excluded from the study.

 Ocular manifestations due to other systemic and autoimmune diseases such as Reiter’s, Ankylosing
spondylitis , psoriatic arthritis .

METHOD
Patients included in the study will be evaluated and a detailed history and examination will be done:

History
The demographic details of the patients will be recorded. In all cases, a detailed history will be taken pertaining
to
 Duration of RA
 Systemic manifestations of RA
 Drug use and duration of treatment
 Family history of RA
 Symptoms pertaining to ocular manifestations

Ocular Examination
It will include
 Best corrected visual acuity
 Testing for color vision
 Amsler’s grid
 Slit lamp examination of anterior segment
 Detailed fundus examination
 Intraocular pressure measurement
 Tests for dry eyes
 Visual fields and B-scan if necessary were performed
 Spectral domain optical coherence topography where required.
 DATA WILL BE RECORDED IN PREDESIGNED PROFORMA

PROFORMA

NAME:

AGE :

SEX :

DATE:

REG. No. :

UNIT:

CLINICAL PROFILE

CHIEF COMPLAINTS:

HISTORY OF PRESENT ILLNESS:

PERSONAL HISTORY:

PAST MEDICAL AND SURGICAL HISTORY:

FAMILY HISTORY:
 GENERAL PHYSICAL EXAMINATION

PULSE:

BLOOD PRESSURE:

OPHTHALMOLOGICAL EXAMINATION

VISUAL ACQUITY: SNELLEN’S CHART

BCVA (Best Corrected Visual acuity)

AMSLER’S CHART

IOP

Slitlamp biomicroscopy of anterior segment

i. Adenexa :

ii. Cornea :

iii. Conjunctiva : Schirmer’s Test

Tear film break-up time

iv. Anterior chamber :

v. Iris(including iris colour) :

vi. Pupils :

vii. Lens :
 POSTERIOR SEGMENT

- FUNDUS : DIRECT/ INDIRECT OPHTHALMOSCOPY

SLIT LAMP BIOMICROSCOPY USING 90D LENS

OD OS

RESULT:
After collection of the sample data and processing it the result will be shown.

CONCLUSION
References:
1. Charanya, et al.: Ocular Manifestation in Rheumatoid Arthritis, International Journal of
Scientifc Study | November 2015 | Vol 3 | Issue 8 66 manifestations and association with
rheumatoid arthritis. Br J Ophthalmol 1976;60:192-226.
2. Reddy SC, Gupta SD, Jain IS, Deodhar SD. Ocular manifestations of rheumatoid arthritis. Indian
J Ophthalmol 1977;25:20-6.
3. Moss SE, Klein R, Klein BE. Prevalence of and risk factors for dry eye syndrome. Arch
Ophthalmol 2000;118:1264-8.
4. Watson PG, Hayreh SS. Scleritis and episcleritis. Br J Ophthalmol 1976;60:163-91.
5. Jabs DA, Mudun A, Dunn JP, Marsh MJ. Episcleritis and scleritis: Clinical features and
treatment results. Am J Ophthalmol 2000;130:469-76.
6. McGavin DD, Williamson J, Forrester JV, Foulds WS, Buchanan WW,Dick WC, et al.
Episcleritis and scleritis. A study of their clinical
7. Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American
College of Rheumatology. Preliminary defnition of improvement in rheumatoid arthritis.
Arthritis Rheum 1995;38:727-35.
8. Turesson C, O’Fallon WM, Crowson CS, Gabriel SE, Matteson EL. Extraarticular disease
manifestations in rheumatoid arthritis: Incidence trends and risk factors over 46 years. Ann
Rheum Dis 2003;62:722-7.
9. Sahatciu-Meka V, Rexhepi S, Manxhuka-Kerliu S, Rexhepi M. Extraarticular manifestations of
seronegative and seropositive rheumatoid arthritis. Bosn J Basic Med Sci 2010;10:26-31.
10. Lilleby V, Gran JT. Systemic rheumatoid arthritis. Tidsskr Nor Laegeforen 1997;117:4223
11. Goronzy JJ, Weyand CM. Developments in the scientifc understanding of rheumatoid arthritis.
Arthritis Res Ther 2009;11:249.
12. Cimmino MA, Salvarani C, Macchioni P, Montecucco C, Fossaluzza V, Mascia MT, et al. Extra-
articular manifestations in 587 Italian patients with rheumatoid arthritis. Rheumatol Int
2000;19:213-7.
13. Copeman WS, Scott JT. Copeman’s Textbook of Rheumatic Diseases. 5th ed. London: Churchill
Livingstone; 1978. p. 3-10.
14. Albert MD, Miller WJ, Azar TD, Blodi AB. The eye and systemic disease, childhood arthritis and
anterior uveitis. Albert and Jakobiec’s Principles and Practice of Ophthalmology. 2nd ed., Vol. 5.
Amsterdam, Netherlands: Elsevier Academic Press; 1994. p. 4542-54.
15. Patel SJ, Lundy DC. Ocular manifestations of autoimmune disease. Am Fam Physician
2002;66:991-8.
16. Kotaniemi KM, Salomaa PM, Sihto-Kauppi K, Säilä HM, Kauppi MJ. An evaluation of dry eye
symptoms and signs in a cohort of children with juvenile idiopathic arthritis. Clin Ophthalmol
2009;3:271-5.
17. Kimura SJ, Hogan MJ, O’Connor GR, Epstein WV. Uveitis and joint diseases. Clinical fndings
in 191 cases. Arch Ophthalmol 1967;77:309-16.
18. Easterbrook M. Detection and prevention of maculopathy associated with antimalarial agents. Int
Ophthalmol Clin 1999;39:49-57.
19. Vu BL, Easterbrook M, Hovis JK. Detection of color vision defects in chloroquine retinopathy.
Ophthalmology 1999;106:1799-803.
th
20. Hochberg, Silman, Smolen, Weinblatt, Weisman. Rheumatology text book 4 ed., vol. 2nd
 Consent Form
PARTICIPANT’s NAME –

ADDRESS –

TITLE OF PROJECT “BURDEN OF OCULAR MANIFESTATIONS IN PATIENTS OF

RHEUMATOID ARTHRITIS IN TERTIARY CARE CENTRE OF KUMAON REGION
UTTARAKHAND”

The detail of study has been provided to me in writing and explained to me in my own language. I confirm that I
understood the above study and opportunity to ask questions. I understand that my participation is voluntary and
that I am free to withdraw at any time, without giving any reason. I agree not to restrict any use of the data or
result that arises from the study provided such use is only for scientific purpose(s). I have been given information
sheet giving detail of the study. I fully consent to participant in this study.

Date: (Signature of Candidate)

 DECLARATION FORM

I , Dr Smriti Chikara, hereby declare that I will not disclose identity of the research
participants any time during or after the study period or during publication.

Signature of Investigator