RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

KARNATAKA, BANGALORE

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

|1. |NAME OF THE CANDIDATE |DR.SRUTHI PERAVALI |

| |AND ADDRESS |D/O P.CHANDRA SEKHARA RAO |

| |(IN BLOCK LETTERS) |D.No-59A-8-5, |

| | |TEACHERS COLONY 4TH ROAD |

| | |SAI BABA TEMPLE STREET |

| | |VIJAYAWADA |

| | |ANDHRA PRADESH-520010 |

|2. |NAME OF THE INSTITUTION |J.J.M.MEDICAL COLLEGE, DAVANGERE |

|3. |COURSE OF STUDY AND SUBJECT |M.S. - OPHTHALMOLOGY |

|4. |DATE OF ADMISSION TO COURSE |01-06-2012 |

|5. |TITLE OF TOPIC | |

| | |“CLINICAL STUDY OF CHRONIC BLEPHARITIS-A PROSPECTIVE STUDY” |

|6. |BRIEF RESUME OF THE INTENDED WORK |

| |6.1 Need for the study: |

| |Chronic blepharitis is one of the most common conditions seen in Ophthalmologist’s practice but it is difficult to treat because|

| |it is an extremely common condition that manifests several different overlapping arrays of signs and symptoms. 1 |

| |Symptoms of chronic blepharitis include Burning, Grittiness, Itching and crusting, redness of lid margins usually worse in the|

| |mornings with remissions and exacerbations.2 |

| |Chronic blepharitis has classically been described as being anterior, posterior or mixed.3 Chronic posterior |

| |blepharitis/Meibomian Gland Dysfunction is frequently overlooked despite it affecting over 60 to 86% of patients who come for |

| |routine visits. Aqueous tear deficiency is a concomitant disease in many patients with Meibomian Gland Dysfunction.4 |

| |Blepharokeratoconjunctivitis is an important and underdiagnosed chronic inflammatory disorders -clinical manifestations ranging|

| |from chronic eyelid inflammation, recurrent chalazia, phlyctens with corneal neovascularisation and scarring and may compromise|

| |visual acuity and may lead to amblyopia in children. 5 |

| |Wills eye manual recommends warm compress for 15 min four times per day; clean with wet cotton bud and mild baby shampoo, |

| |topical antibiotics at night for moderate to severe cases, systemic tetracycline 250mg 4 times a day or doxycycline 100mg twice |

| |day for 6 weeks in recurrent cases and adjunctive treatment in the form of lubricants 4 to 8 times a day. 3 |

| |Despite the high prevalence of this condition blepharitis has been a poorly understood clinical entity and posed a considerable |

| |diagnostic and therapeutic challenge to practicing eye care providers. 6 |

| |Staphylococcal infection of the lid alone or in combination with seborrhic dermatitis has been considered the commonest cause of|

| |blepharitis but in meibomanitis staph aureus was present deep within the meibomian glands and was inaccessible to |

| |microbiologists probings7.It is difficult to find a pathogenic bacterium in 88% of cases of blepharitis and in all meibomanitis |

| |cases 8 |

| |In the present study an attempt will be made to study the clinical characteristics,complications, associated disorders and |

| |management of chronic blepharitis. |

| | |

| |6.2 Review of Literature: |

| |Arie Y. Nemet, et al conducted a retrospective observational case-control study to evaluate the prevalence of various ocular and|

| |systemic conditions in patients with blepharitis and found strongest association with chalazia(OR 4.7), rosacea(OR 3)and |

| |pterygium(OR 2).9 |

| |Michael A. Lemp, et al conducted a survey-based perspective on prevalence and treatment of blepharitis in which he studied 5000 |

| |adults aged 18 years and older living in private households and recorded prevalence of symptoms as dry/irritated eyes in |

| |53%,watering of eyes in 36%,heaviness of eyelids in 35% followed by burning or itching eyelids in 32%.They found dry eye to be a|

| |common comorbidity with Meibomian Gland Dysfunction. 10 |

| | |

| |Amal A. Bukhari, conducted a prospective interventional study on prevalence of Obstructive Meibomian Gland Disease in 420 |

| |patients and found it to be in 77.6% of patients.Anterior Blepharitis was found in 85%,Giant Papillary Conjunctivitis in |

| |6.7%,corneal scar in 1.5%,Entropion and or Trichiasis in 0.9%.11 |

| |Sophie M. Jones, et al studied 27 children with Blepharokeratoconjunctivitis and showed Photophobia in 52%,Acne Rosacea in |

| |11%,Corneal involvement in 81%,Recurrent chalazia in 67%.Best-corrected visual acuity improved in 70% of affected |

| |eyes.Superimposed amblyopia was seen in 48%.Bilateral corneal involvement was seen in 20% who failed to achieve good visual |

| |acuity after treatment. 12 |

| |M. Viswalingam. et al studied Blepharokeratoconjunctivitis in 44 children for 11 years found M:F ratio 20:24,Median age at onset|

| |4.1 years, the most prevalent symptoms were Discharge in 65.9% followed by Photophobia in 63.6%.The most prevalent signs were |

| |Papillary hyperplasia in 50% and Hyperaemia in 47.7% and the most common corneal complications being Superficial Punctate |

| |Keratitis in 63.6% and Marginal infiltrates in 63.6% . 13 |

| |Tomo Suzuki, et al studied association of meibomitis with phlyctenular keratitis in 23 patients aged under 35 years with |

| |phlyctenular keratitis.87% were women,56.5% had a history of chalazia. The lesions and severity of corneal nodules and |

| |neovascularisation corresponded well with the location and severity of meibomitis.14 |

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| | |

| |6.3 Objectives of the Study: |

| |To describe the clinical characteristics, complications of Chronic Blepharitis and association with other disorders. |

| |To study the management of chronic Blepharitis and effect of treatment on clinical parameters. |

|7. |MATERIALS AND METHODS |

| |7.1 Source of data: |

| |All patients attending the Department of Ophthalmology at Chigateri General Hospital and Bapuji Hospital attached to J.J.M. |

| |Medical College, Davangere will be included in this study. |

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| | |

| |7.2 Methods of collection of data (including sampling procedure): |

| |This is a prospective and time bound study in which all patients presenting with Symptoms and signs of Chronic Blepharitis from|

| |November 2012 to September 2014 will be included. |

| |Inclusion Criteria: |

| |All patients attending the Department of Ophthalmology at JJM Medical College, Davangere will be included in this study. |

| |Exclusion Criteria : |

| |Patients with : |

| |1.Acute eyelid inflammation |

| |2.Other eyelid disorders other than Chronic Blepharitis. |

| | |

| |Sample Size: Minimum 50 cases will be included. |

| |Changes in clinical parameters after treatment will be subjected for analysis. Categorical data will be analyzed by chi-square |

| |test. |

| | |

| |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” |

| |i. Visual acuity by Snellen’s chart |

| |ii. Keratometry |

| |iii. Slit lamp examination |

| | |

| |7.4 Has ethical clearance been obtained from your institution in Case of 7.3 ? |

| |“Yes” |

|8. |LIST OF REFERENCES: |

| |James P. McCulley, et al Changing Concepts In The Diagnosis and Management of Blepharitis. Cornea 2000;19(5):650-658. |

| |Jack J Kanski, Brad Bowling. Clinical Ophthalmology: a systematic approach, 7th edition,p:34-36. |

| |Penny Asbell, et al. A Diagnostic and Treatment Strategy for Dry Eye Associated With Meibomian Gland Dysfunction. Ophthalmology|

| |Times Europe 2011. |

| |Gerd Geerling, et al. International Workshop On Meibomian Gland Dysfunction: Report of the Subcommittee on Management and |

| |Treatment of Meibomian Gland Dysfunction. Investigative Ophthalmology And Visual Science 2011;52(4):2050-2064. |

| |Kristin M. Hammersmith, et al. Blepharokeratoconjunctivitis in children. Arch Ophthalmology 2005;123:1667-1670. |

| |Ronald E. Smith, et al. Chronic Blepharitis: A Review. CLAO 1995;21(3):200-207. |

| |Joel M. Dougherty, et al. Comparative bacteriology of chronic blepharitis. British Journal of Ophthalmology 1984,68,524-528 |

| |D V Seal, et al. Microbial and immunological investigations of chronic non-ulcerative blepharitis and meibomanitis. British |

| |Journal of Ophthalmology 69, 604-611. |

| |Arie Y. Nemet, et al. Associated Morbidity of Blepharitis. Ophthalmology 2011;118:1062-1068. |

| |Michael A. Lemp, et al. Blepharitis in the United States 2009:A Survey-Based Perspective on Prevalence and Treatment. Ocular |

| |Surface 2009;7(2 Suppl)S1-S14. |

| |Amal A. Bukhari. Prevalence of Obstructive Meibomian Gland Disease among Ophthalmology Patients. JKAU Med Sci 2009;16(2):69-76.|

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| |Sophie M.Jones, et al. Visual Outcome And Corneal Changes in Children with Chronic Blepharokeratoconjunctivitis. Ophthalmology |

| |2007;114(12):2271-2280. |

| |M Viswalingam, et al. Blepharokeratoconjunctivitis in children-diagnosis and treatment. British Journal of Ophthalmology |

| |2005;89:400-403 |

| |Tomo Suzuki, et al. Phlyctenular Keratitis Associated With Meibomitis in Young Patients. Am J Ophthalmol 2005;140:77-82. |

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|9. |Signature of candidate | |

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|10 |Remarks of the guide | |

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|11 |Name & Designation of (in block letters) | |

| |11.1 Guide | |

| | |Dr. M.S.POORNIMA M.S., |

| | |Professor, |

| | |Department of OPHTHALMOLOGY, |

| | |J.J.M. Medical College, |

| | |DAVANGERE - 577 004. |

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| |11.2 Signature | |

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| |11.3 Co-Guide (if any) | |

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| |11.4 Signature | |

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| |11.5 Head of Department | |

| | |Dr. S.V. RAVINDRANATH M.S., D.O.M.S. |

| | |Professor and Head, |

| | |Department of OPHTHALMOLOGY, |

| | |J.J.M. Medical College, |

| | |DAVANGERE - 577 004. |

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| |11.6 Signature | |

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|12 |12.1 Remarks of the | |

| |Chairman & | |

| |Principal | |

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| |12.2. Signature. | |

Approval of Ethics Committee

To

Dr. SRUTHI PERAVALI

Postgraduate,

DEPARTMENT OF OPHTHALMOLOGY,

J.J.M. Medical College, Davangere.

The Institutional Ethics Committee, J.J.M. Medical College, Davangere has reviewed and discussed your application to conduct the study/dissertation entitled

Title: “CLINICAL STUDY OF CHRONIC BLEPHARITIS – A PROSPECTIVE STUDY”

The following documents were reviewed :

a. Trial Protocol (including protocol amendments), dated __________ Version no. (s). ___________ (not applicable).

b. Patient information sheet and Informed Consent form (including updates if any) in English and/or vernacular language. (yes) in Vernacular language.

c. Investigator’s Brochure, dated ______________, Version no. _________ (not applicable).

d. Proposed methods for patient accrual including advertisement (s) etc. proposed to be used for the purpose. (not applicable)

e. Principal Investigator’s current CV.

f. Insurance Policy / Compensation for participation and for serious adverse events occurring during the study participation (not applicable)

g. Investigators agreement with the sponsor. (not applicable)

h. Investigators Undertaking (Appendix VII) (not applicable).

We approved the study to be conducted in its presented form.

The Institutional Ethics Committee, J.J.M. Medical College, Davangere expects to be informed about the progress of the study, any SAE occurring in the course of the study, any changes in the protocol and patient information/ informed consent and asks to be provided a copy of the final report.

Your sincerely,

|Member Secretary, Ethics Committee |Chairman/Vice Chairman |

| |Ethics Committee |

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