Rajiv Gandhi university of health sciences,



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA.

ANNEXURE –II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

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|1. |NAME OF THE |DR. PRIYA D |

| |CANDIDATE | |

| |ADDRESS |C/O SURESH D |

| | |#188, CHADURANGA, PARAMOUNT GARDEN, THALAGATTAPURA, KANAKPUR MAIN ROAD, BANGALORE-|

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|2. |NAME OF THE INSTITUTION |BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, BANGALORE. |

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|3. |COURSE OF |M.S. OPHTHALMOLOGY |

| |STUDY AND | |

| |SUBJECT | |

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|4. |DATE OF |31st MAY 2011 |

| |ADMISSION | |

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|5. |TITLE OF THE TOPIC |DRY EYE EVALUATION BEFORE AND AFTER CATARACT SURGERY |

|6. |Brief resume of intended work |

| |6.1. Need for study: |

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| |Dry eye is a frequently encountered ocular problem in our tropical climate1. It occurs when there is inadequate tear|

| |volume or function resulting in an unstable tear film and ocular surface disease2. A dry eye produces discomfort and|

| |reduces vision when the tear film becomes chronically unstable and repeatedly breaks up into dry eye spots between |

| |the blinks, exposing the corneal and conjunctival epithelium to evaporation3. |

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| |Dry eye-associated symptoms, such as foreign body sensation and fatigue, frequently occur after cataract surgery. |

| |Affected patients may experience red or watery eyes along with constant foreign body sensation. Several published |

| |studies have documented the aggravation of dry eye symptoms and signs after LASER insitu keratomileusis and |

| |penetrating keratoplasty. Some studies have even reported aggravation of dry eye symptoms and signs after cataract |

| |surgery4 |

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| |Dry eye can develop or deteriorate after cataract surgery if not treated in time. Misuse of eyedrops is one of the |

| |major pathogenic factors . Indiscriminate use of topical antibiotics causes histological and ultrastructural changes|

| |in conjunctiva leading to decreased tear break-up time and dry eye state5. It is significantly important for |

| |maintaining of the ocular surface stability and recovery of vision acuity after cataract surgery to do early |

| |diagnose and promptly manage the dry eye syndrome6. |

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| |6.2. Review of literature: |

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| |Li XM et al.7 observed that after cataract surgery, the incidence of dry eye increased dramatically. Tear river was |

| |narrowed, Break up time and Schirmers test I were decreased and shorted in patients after cataract surgery. |

| |Impression cytology examination showed there was serious squamous metaplasia in epithelial layer of conjunctiva . YK|

| |Cho et al.4 studied effect of cataract study on tear film in previously dry eye and non dry eye subjects. All dry |

| |eye test values were significantly worse after cataract surgery in the non-dry eye group. |

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| |Khanal S et al.8 on a study showed tear physiology recovered within 1 month. Corneal sensitivity did not return to |

| |normal levels in 3 months, but a trend towards full recovery was seen. Saline and the tear lubricant were not found |

| |to have an effect on the improvement of tear physiology and corneal sensitivity post-surgically. |

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| |A study was carried by Sitompul R et al.9 showed in the group undergoing phacoemulsification, corneal sensitivity |

| |decreased at the incision site and at other sites on days 1, 7, and 15 after surgery, whereas in the group |

| |undergoing manual small incision cataract surgery, no change in corneal sensitivity was noted. Between-group |

| |difference in corneal sensitivity was significant on days 1, 7, and 15. Patient symptoms significantly increased on |

| |day 1 in both groups, and the difference between the 2 groups was significant on day 15 . |

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| |A clinical study done by Sun XG et al.6 showed two kinds of dry eye after cataract surgery, early dry eye and |

| |chronic dry eye. Most cases of early dry eye, who usually had the normal lacrimal secretion before surgery, were |

| |reversible and involved in some of factors associated with surgery and post-surgery medication. But most cases of |

| |chronic dry eye, who have abnormal lacrimal secretion or "borderline state" of lacrimal secretion test before |

| |surgery, may suffer from the ocular surface diseases related to irreversible dry eye disease . |

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| |6.3. Aims and Objectives of the study: |

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| |To know the influence of cataract surgery on tear film |

| |To measure dryness symptoms using Ocular surface disease Index(OSDI) score. |

| |To quantify changes in tear film using tear meniscus height, Schirmers test I, tear break up time, Rose Bengal test.|

|7.0 |Materials and methods |

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| |7.1. Source of data: |

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| |Cases admitted for small incision cataract surgery at Minto Ophthalmic Hospital Bangalore, Regional Institute of |

| |Ophthalmology attached to Bangalore Medical College and Research Institute. |

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| |7.2. Method of collection of data: |

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| |Study Design |

| |Prospective study |

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| |Study period |

| |November 2011 to May 2013 |

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| |Place of study |

| |Minto Ophthalmic Hospital, Regional Institute of Ophthalmology attached to Bangalore Medical College and Research |

| |Institute. |

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| |Sample size. |

| |Minimum of 100 cases |

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| |Inclusion criteria. |

| |Patient who have given written informed consent in their language. ( Annexure I ). |

| |Random selection of patient planning for Small incision cataract surgery. |

| |Should receive same brand of ofloxocin dexamethasone combination eye drops post surgery |

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| |Exclusion criteria. |

| |1. Pre existing ocular disease like: |

| |- Dry eye |

| |- Complicated cataract |

| |- Glaucoma |

| |- Uveitis |

| |- Disorder of lids and nasolacrimal duct pathway |

| |- Ocular allergies |

| |- pterygium |

| |2. Previous ocular surgery |

| |3. Current smoker |

| |4. Any intra operative complications during this surgery |

| |5. Insertion of Anterior chamber intraocular lens |

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| |Methodology |

| |Patient who are undergoing small incision cataract surgery are selected for the study who have given written consent|

| |after explaining the procedures involved and after fitting inclusion and exclusion criteria. Dryness symptoms is |

| |assessed using Ocular surface disease index(OSDI) scores and it is quantified using slit lamp biomicroscopy, |

| |Schirmer’s test I, tear break up time (TBUT), tear meniscus height, rose Bengal test. Corneal sensations to be |

| |checked. Subjects were assessed one day prior to the surgery, and followed up day one, one week, three week and six |

| |weeks following surgery. |

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| |Statistical Analysis. |

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| |Depending upon the data available appropriate statistical test will be applied qualitatively by chi-square and |

| |quantitatively by paired t- test or z test. |

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| |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 |

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| |Yes. It involves following investigations and interventions on human subjects. |

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| |Schirmers test I |

| |Tear break up time (TBUT). |

| |Fluorescein staining |

| |Rose Bengal test |

| |Corneal sensation testing |

| |Small incision cataract surgery. |

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| |7.4. Has the ethical clearance been obtained from your institution in case of 7.3 |

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| |Yes |

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|8. |List of references: |

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| |Sukul RR, Shukla M, Nagpal G. Tear film break up time in normal Indian subjects. Indian J Ophthalmol 1983;31:326 |

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| |2. Kanski JJ, Bowling B, Dry Eye disorders. Clinical Ophthalmology- A Systematic Approach, seventh edition, |

| |Elsevier Saunders, 2011; 121-128 |

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| |3. Sihota R, Tandon R, Diseases of Lacrimal Apparatus. Parsons’ Diseases of the Eye. Twenty first edition,India, |

| |Elsevier publications, 2011;29:463-69 |

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| |4. Yang KC and Man SK, Dry after cataract surgery and associated intra operative complications, Korean J Ophthalmol.|

| |2009 Jun;23(2):65-73. |

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| |5. Arun KS, Alka G, Tulika D. Indiscriminate use of topical antibiotics: A menace. Indian J Ophthalmol 1999;47:121-4|

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| |6. Sun XG, Shi YY, Zhang C.Not to ignore the dry eye of cataract patients after surgery. Zhonghua Yan Ke Za Zhi. |

| |2008 Apr;44(4):291-2. |

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| |7. Li XM, Zhao X, Hu LZ, Wang W. Clinical observation of dry eye in patients before and after cataract surgery. |

| |Zhonghua Yan Ke Za Zhi. Jan;43(1):10-3. |

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| |8. Khanal S, Tomlinson A, Esakowitz L, Bhatt P, Jones D, Nabili S, Mukerji S. Changes in corneal sensitivity and |

| |tear physiology after phacoemulsification. Ophthalmic physiol Opt 2008 Mar; 28(2):127-34 |

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| |9. Sitompul R, Sancoyo GS, Hutauruk JA, Gondhowiardjo TD. Sensitivity change in cornea and tear layer due to |

| |incision difference on cataract surgery with either manual small-incision cataract surgery or phacoemulsification. |

| |Cornea. 2008 Sep; 27 Suppl 1:513-8. |

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|9. |Signature of the candidate: | |

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| | |Dr. PRIYA. D |

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|10. |Remarks of the Guide |

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| |Incidence of dry is increasing for various reasons. Commonest surgery being performed is cataract surgery. We do |

| |detailed examination before considering patient for cataract surgery. It is very essential to know the dry eye |

| |status before and after cataract surgery. Therefore a scientific study of the dry eye to be done for better outcome |

| |and prevention of complications. |

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|11. |Name and Designation | |

| |11.1.Guide: |Prof. Dr. Raviprakash. D |

| | |MBBS, MS(Opthal) |

| | |Professor in Ophthalmology |

| | |( Cornea and Eye Bank) |

| | |Head of the Department |

| | |( Ophthalmology) |

| | |Minto Ophthalmic hospital & Regional Institute of Ophthalmology|

| | |Bangalore Medical College and research Institute |

| | |Bangalore |

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| |11.2. Signature: | |

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| |11.3 Co-guide (if any): | |

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| | |NONE |

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| |11.4. Signature: | |

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| |11.5.Head of the Department: |Prof. Dr. Raviprakash. D |

| | |MBBS, MS(Opthal) |

| | |Professor in Ophthalmology |

| | |( Cornea and Eye Bank) |

| | |Head of the Department |

| | |( Ophthalmology) |

| | |Minto Ophthalmic hospital & Regional Institute of Ophthalmology|

| | |Bangalore Medical College and research Institute |

| | |Bangalore |

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| |11.6. Signature | |

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| |12.1.) Dean and Director of |Prof. Dr. O. S. Siddappa, |

| |Bangalore Medical College |Dean & Director, |

| |& Research Institute |Bangalore Medical College and Research Institute |

| | |Bangalore. |

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| |12.2.) Remarks of the Dean & director : | |

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| |12.3.) Signature : | |

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ANNEXURE I

I, Mr/ Mrs/ Ms _________________, exercising my own free will power of choice, hereby give consent for myself as an object in the DRY EVALUATION BEFORE AND AFTER CATARACT SURGERY conducted by Prof Dr. Raviprakash D, Dr. Priya D, department of Ophthalmology, Minto Ophthalmic Hospital, Regional Institute of Ophthalmology attached to Bangalore Medical College and Research Institute, Bangalore.

The attending doctors have informed me to my satisfaction and in the language best understood by me, the purpose of this study, the materials to be used during the course of this study as well as the side effects/ complications associated with methods/ tools to be used.

I shall not hold doctors or the staff responsible for any untoward consequences.

I am also aware of my right to opt out of the study without prejudice to further treatment at any time during the course of the study without having to give reasons to do so.

Signature of the attending doctor: Signature/ Left thumb

Impression of the patient

DATE:

Signature of the witness:

DATE:

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