RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, …



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE

Annexure –II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR

DISSERTATION

|1 |Name of the Candidate and Address |DR. KOMAL. G, |

| | |Department of Ophthalmology, |

| | |A. J. Institute Of Medical Sciences, Kuntikana, Mangalore-04. |

| | | |

|2 |Name of the Institution |A. J. Institute Of Medical Sciences, Kuntikana, Mangalore-04. |

|3 |Course of Study and Subject |M.S. in Ophthalmology |

| | |(3 Years Degree Course) |

|4 |Date of Admission to the Course |25 May 2009 |

|5 |Title of the Topic: |“ULTRASOUND BIOMICROSCOPIC EVALUATION OF ANGLE OF ANTERIOR CHAMBER IN|

| | |COMPARISON WITH GONIOSCOPY”. |

|6. |BRIEF RESUME OF THE INTENDED WORK: | |

| |6.1 Need for the study | |

| | |To compare the ultrasound biomicroscopic (UBM) measurement of the|

| | |anterior chamber angle in patients attending ophthalmology OPD, |

| | |with the angle width estimated by gonioscopy done with three |

| | |mirror Goniolens . To demonstrate added advantages of UBM over |

| | |gonioscopy in high resolution imaging of anterior segment. |

| | |The UBM transducer has sufficient sensitivity for visualization of |

| | |cornea ,ciliary body & angle structures. |

| | |UBM can provide images of subcutaneous ocular adenexal structures|

| | |& foreign bodies with good spatial resolution and acceptable |

| | |tissue penetration. It represents a non-invasive device for |

| | |visualization of normal upper eyelid and the lacrimal drainage |

| | |system anatomy. |

| | |UBM also allows quantitative measurements of tumor size, |

| | |extension within and posterior to the iris, as well as |

| | |differentiation of solid and cystic lesions. |

| | |It also provides quantitative analysis for measurements of |

| | |anatomic structures and their configurations within anterior |

| | |segment and hence yield significant information about mechanisms |

| | |of appositional angle closure, dynamic functions of the iris, |

| | |accommodation and presbyopia. |

| | |The various forms of angle closure glaucoma, such as pupillary |

| | |block and plateau iris configuration, can be assessed with UBM |

| | |. Visualization of anterior segment anatomy in eyes with |

| | |opaque media and dense corneal opacities of different |

| | |etiologies, is also possible and hence assists in the management |

| | |of eyes with anterior segment disorders. |

| |6.2 Review of Literature |UBM is helpful in clinical diagnostic imaging of the anterior |

| | |segment . It is also precise in measuring the angle of anterior |

| | |chamber in comparision with goniosccopy done with Goldmann three |

| | |mirror goniolens which has been proved in following studies. |

| | |UBM measurements in each case and analyzed in relation to |

| | |gonioscopic angle evaluation. 163 eyes were analyzed in which 106 |

| | |eyes had “narrow angles” and 57 had “open angles” on gonioscopy. |

| | |There was significant difference among mean UBM measurements of |

| | |each angle grade estimated by gonioscopy( P< 0.001).6 |

| | |The results after examining same eyes by UBM and gonioscope were|

| | |compared and the data were analyzed to be well consistent only |

| | |when the angle was wide. The angle examined by a gonioscope was|

| | |wider than that by UBM. Under the influence of light the |

| | |determination of iris root insertion by a gonioscope has a sense |

| | |of conjecture.4 |

| | |500 subjects were evaluated for grading of angle width by the |

| | |Shaffer method and UBM was done to document angle width, angle |

| | |opening distance( AOD) and anterior chamber depth. Subjective |

| | |assessment by gonioscopy resulted in an overestimation of angle |

| | |width. UBM required for objective quantification of angles.7 |

| | |UBM produces images of cross sections of intact anterior globe |

| | |at microscopic resolution allowing a new quantitative method of |

| | |gonioscopy. 14 clinical cases study has shown that differentiation |

| | |of tissue on the basis of internal acoustic characteristics is |

| | |aided by the very fine backscatter speckle pattern at these |

| | |frequencies.1 |

| | |Ciliary body and cornea of human eye were scanned six years post- |

| | |LASIK. Images from 75 MHz lithium niobate transducer were compared |

| | |with 35 MHz . Images with 75 MHz showed higher stromal backscatter and |

| | |hence better visualization of Bowman’s layer ,iris and ciliary body.5|

| | |UBM was used in patients to evaluate existence of ciliary body |

| | |tumour. UBM also showed origin of tumour from ciliary body |

| | |rather than choroid which was shown by the B scan ultrasound.10 |

| | |UBM morphologic characters of anterior chamber angle of high-risk |

| | |chamber angle and adhered angle groups were examined under |

| | |different illumination ,which showed significant influence of |

| | |illumination on findings to explore a dynamic differentiating |

| | |method.3 |

| | |Patients with appositional angle closure were enrolled to |

| | |perform dark –room gonioscopy with 1 mm slit lamp beam . |

| | |Ultrasound biomicroscopic images were acquired in normal room light|

| | |and subsequently with all room lights off to evaluate presence |

| | |or absence of iris cornea contact.8 |

| | |UBM has revolutionized the evaluation of anterior segment of the |

| | |eye to understand the pathology of angle-closure glaucoma, |

| | |pigmentary glaucoma and quantitive analysis to yield mechanism of|

| | |appositional angle closure , dynamic functions of iris, |

| | |accommodation and presbyopia.2 |

| | |Diagnosis and treatment of angle- closure glaucoma are intricately|

| | |related to angle assessment techniques. Hence gonioscopy, ultrasound |

| | |biomicroscopy and anterior segment optical coherence tomography |

| | |were reviewed to assess the anterior chamber angle directly.9 |

| |6.3 Objective of the Study | To compare ultrasound biomicroscopic |

| | |measurement of the anterior chamber angle with Gonioscopy in patients |

| | |attending Ophthalmology OPD at A. J. Institute Of Medical Sciences . |

| | |To evaluate ability of ultrasound |

| | | |

| | |biomicroscopy as a predictor of glaucoma to |

| | | |

| | |diagnose early stages of glaucoma. |

| | | |

| | |To evaluate iris root insertion in narrow |

| | | |

| | |angle using UBM . |

| | | |

| | |To analyze UBM to be more precise method |

| | | |

| | |in direct documentation of all structures |

| | | |

| | |involved in chamber angle configuration. |

| | | |

| | | |

|7. |Materials and Methods: | |

| |7.1 Source of Data |It is a hospital based study. Patients attending ophthalmology OPD |

| | |in A. J .Institute Of Medical Sciences between |

| | |the age group of 20 to 70 years . |

| |7.2 Method of the Collection of the Data | |

| | |Study Design: One year prospective study. |

| | |Sample size: 100 |

| | | |

| | | |

| | |Sample: It is a hospital based study. Study done on patients |

| | |attending Ophthalmology OPD between the age group of 20 to 70 |

| | |years |

| | |Place: A.J. Institute Of Medical Sciences , Mangalore. |

| | |Duration: One year from December 2009 to November 2010. |

| | |Method: |

| | |Patients between the age group of 20 to 70 will be selected |

| | |randomly among patients attending A.J. Institute Of Medical |

| | |Sciences, Ophthalmology OPD. |

| | |100 patients will be enrolled for study after obtaining an |

| | |informed consent, examined thoroughly using slit lamp examination|

| | |of the anterior segment , intraocular pressure measurement by |

| | |applanation tonometry ,gonioscopic visualization of angle of |

| | |anterior chamber using Goldmann 3 mirror goniolens and Ultrasound |

| | |Biomicroscopic evaluation of anterior segment and angle of |

| | |anterior chamber will be done. |

| | |Results of the Gonioscopic and Ultrasound Biomicroscopic examination|

| | |will be compared for anterior segment structure visualization and|

| | |measurement of angle of anterior chamber . |

| | |Hence the advantages of UBM documented over gonioscopy for high|

| | |resolution imaging of anterior segment and precise measurement |

| | |of angle of anterior chamber. |

| | |Inclusion criteria: |

| | |1.Patients attending Ophthalmology OPD between age group of 20 to 70. |

| | |2.Patients with CDR >0.4 on fundoscopy. |

| | |3. Patients with raised IOP. |

| | |4.Patients with clinically suspected narrow angle. |

| | |5.Patients with clinically suspected zonular abnormalities. |

| | | |

| | |Exclusion criteria: |

| | |1.Patients below 20 years of age. |

| | |2.Patients above 70 years of age. |

| | |3.Patients with conjunctivitis, keratitis & uveitis. |

| | |4.Patients with perforating injury. |

| | |5.Patients with corneal haziness. |

| | | |

| | |Data analysis: |

| | |The comparative study between Ultrasound Biomicroscopy and |

| | |Gonioscopy in diagnosing various diseases of the anterior |

| | |segment . |

| |7.3 Does the study require any investigations or |Yes |

| |interventions to be conducted on patients or other |Measurement of angle of anterior chamber. |

| |humans or animals? If so, please describe briefly. |Evaluation of anterior segment. |

| |7.4 Has the ethical clearance Been obtained from |Approved |

| |your institution in case of 7.3 | |

|8. |List of References |C.J. Pavlin, K Harasiewicz, M D Sherar, F S Foster dept of |

| | |ophthalmology, Princess Margaret Hospital, Toronto, Canada. Clinical use|

| | |of ultrasound biomicroscopy. Ophthalmology 1995: 102(12):1770-6 |

| | |9098276(P,S,G,E,B). |

| | |H Ishikawa, J M Liebmann, R Ritch Department Of Ophthalmology, New York |

| | |10003,USA. Quantitative assessment of the anterior segment using |

| | |ultrasound biomicroscopy. J Am Optom Assoc 1996 Aug 67(8) 469-79 8888877|

| | |(P,S,G,E,B). |

| | |Huang W, Peng D,Chen X. Study on the dynamic examination of anterior |

| | |chamber angle by ultrasound biomicroscopy. Yan Ke Xue Bao 1998 |

| | |Dec;14(4):204-6. |

| | |Wang N, Ye T, Lai M, Ou Y, Zeng M, Yang C. Comparison of results of |

| | |chamber angle examination by ultrasound biomicroscopy and gonioscopy. |

| | |Zhonghua Yan Ke Za Zhi 1999 May :35(3):174-8, 10. |

| | |Ronald H Silverman, Jonathan Cannata, K. Kirk Shung, Omer Gal, Monica |

| | |Patel, Harriet O.Lloyd, Ernest J. Feleppa & D.Jackson Coleman. 75MHz |

| | |Ultrasound Biomicroscopy Of Anterior Segment Of Eye. Ultrason Imaging , |

| | |2006 July:28(3): 179-189. |

| | |Sushmita Kaushik, Rajeev Jain, Surinder Singh Pandav, Amod Gupta. |

| | |Evaluation of the anterior chamber angle in Asian Indian eyes by |

| | |ultrasound biomicroscopy & gonioscopy. Indian journal of ophthalmology,|

| | |01/10/2006: 54(3):159-63. |

| | |Naryanaswamy A, Vijaya L, Shantha B, Baskaran M, Sathidev AV, Baluswamy |

| | |S. Anterior chamber angle assessment using gonioscopy and ultrasound |

| | |biomicroscopy. Jpn J Ophthalmology 2004 Jan-Feb; 48(1): 44-9. |

| | |Barkana Y, Dorairaj SK, Gerber Y, Liebmann JM, Ritch R. Agreement |

| | |between gonioscopy & ultrasound biomicroscopy in detecting |

| | |iridotrabecular apposition. Arch Ophthalmol 2007 Oct ;125 (10):1417-8. |

| | |Friedman DS, He M. Anterior chamber angle assessment techniques. Surv |

| | |Ophthalmol 2008 May-Jun; 53(3):250-73. |

| | |Ivan Stefanovia, Bojana Dacia-Krnjaja & Smiljka Djuna. Ultrasound |

| | |biomicroscopy in diagnosis of anterior segment pathology. Srp Arch Celok|

| | |Lek 137(3-7); 185-8(2009). |

|9. |Signature of the candidate | |

|10. |Remark of the Guide |Good study which elaborates about the advantages of using UBM |

| | |to evaluate pathology of anterior segment and measuring angle |

| | |of anterior chamber precisely than Gonioscopy. |

|11. |Name and designation of | |

| |11.1 Guide |DR. SUDHIR HEGDE MS. |

| | |Professor & HOD, |

| | |Dept. Of Ophthalmology, A.J. Institute Of Medical Sciences, Kuntikana|

| | |, Mangalore – 04. |

| |11.2 Signature | |

| | | |

| | | |

| |11.3 Co Guide | |

| | | |

| |11.4 Signature | |

| | | |

| |11.5 Head of the Dept. |DR. SUDHIR HEGDE MS. |

| | |Professor & HOD, |

| | |Dept. Of Ophthalmology, A.J. Institute Of Medical Sciences, |

| | |Kuntikana, Mangalore -04. |

| |11.6 Signature | |

|12. |12.1 Remarks of the Chairman and Principal | |

| | | |

| | | |

| | | |

| |12.2 Signature | |

| | | |

CONSENT FOR PARTICIPATION IN RESEARCH

ULTRASOUND BIOMICROSCOPIC EVALUATION OF ANGLE OF ANTERIOR CHAMBER IN COMPARISON WITH GONIOSCOPY.

Purpose of study:

This study is to find out the advantages of ultrasound biomicroscopic evaluation of anterior segment and measurement of angle of anterior chamber over gonioscopic evaluation.

Procedure:

Patients attending Ophthalmology OPD are randomly selected and a detailed clinical examination including applanation tonometry , gonioscopy with Goldmann three mirror lens and ultrasound biomicroscopic examination is done. Then the advantages of UBM over gonioscopy to achieve better visualisation of anterior segment and precise estimation of chamber angle is determined.

Risks:

No life threatening risks involved in the study.

Benefits:

This study will benefit the individual by facilitating in identification of abnormal angle structures and glaucoma screening of high risk individuals.

Alternatives:

Even if you decide not to participate in the study you will receive usual standard care.

Privacy and Confidentiality:

The results of the study may be published for scientific purposes and / or to scientific groups. However you will not be identified. Privacy and confidentiality of the study participants will be ensured.

Institutional Policy

The A. J. Institute Of Medical Sciences will provide, within the limitations of the laws of the State of Karnataka, facilities and medical attention to subject who suffer injuries as a result of participating in its projects. In the event you believe that you have suffered any physical injury as result of your participation in this study you may contact Principal Investigator Dr. Komal .G or Dr.Sudhir Hegde , Guide.

Financial incentive for participation:

You will not receive any payment for participating in this study.

Authorisation to publish results:

Results of this study may be published for scientific purposes or presented to scientific groups; however you will not be identified. No indefinable information will be used for publication or dissemination of the study finding. Only Dr.Sudhir Hegde, Guide and Dr. Komal .G Post graduate student A.J.Institute Of Medical Sciences, Mangalore-04 ,will have access to the data.

Contacts:

If you have any question about the research you may please contact Dr. Ramesh Pai, Principal and Chairman of Ethical Committee, A.J.Institute Of Medical Sciences, Mangalore-04. In case of any emergency you may contact, Dr. Komal .G ,Post Graduate Student, Dept Of Ophthalmology, A.J.Institute Of Medical Sciences, Kuntikana ,Mangalore- 04, Telephone no. 9886567848 or Dr. Sudhir Hegde ,Professor, A.J.institute Of Medical Sciences, Mangalore-04. Telephone no.9880219903.

Your decision whether or not to participate in the study will not affect the standard care during your current or future relations with the hospital. You are free to discontinue the study at any time and for any reason.

Statement of consent

I volunteer and consent to participate in the study. I have read the consent or it has been read to me. The study has been fully explained to me and I may ask questions at any time.

_________________________________________ _________________

Signature or left hand thumb impression of Patient Date

_________________________________________ _________________

Signature of investigator / designee obtaining informed consent Date

_________________________________________ _________________

Signature (Witness) Date

TIME PLAN

TITLE: ULTRASOUND BIOMICROSCOPIC EVALUATION OF ANGLE OF ANTERIOR CHAMBER IN COMPARISON WITH GONIOSCOPY.

|PHASE |TIME PERIOD |OUTLINE OF PLAN |

| | |Identification of the Problem |

| |July 2009 to | |

|I |December 2009 | |

| | |Review of Literature |

| | |Development of proforma |

| | |Conducting Pilot Study |

| | |Submission of Synopsis |

|II |December 2009 to |Enrollment |

| |December 2010 |Data Collection |

| | |Follow up |

|III |January 2011 to |1. Analysis of collected data |

| |July 2011 | |

|IV |July 2011 to |1. Discussion |

| |November 2011 |2. Publication |

PROFORMA

1. Name :

2. Age / Sex :

3. Address :

4. Hospital number :

5. Vision :

6. Intraocular pressure with

Applanation Tonometry :

7. Anterior segment

Findings by Slit-Lamp examination. :

8. Gonioscopy findings :

9. UBM evaluation :

10. Central AC depth :

11. Axial Length :

From

Dr. KOMAL . G .

Post Graduate in Department of Ophthalmology,

A.J.Institute Of Medical Sciences,

Mangalore- 04.

To,

The Registrar (Evaluation),

Rajiv Gandhi University Of Health Sciences,

Bangalore.

(Through Proper Channel)

Sub: Submission of Synopsis of Dissertation

Respected Sir,

Herewith, I am Submitting synopsis of my dissertation work “ULTRASOUND BIOMICROSCOPIC

EVALUATION OF ANTERIOR SEGMENT AND ANGLE OF ANTERIOR CHAMBER

IN COMPARISION WITH GONIOSCOPY” for registration in M.S. (Ophthalmology)

in Rajiv Gandhi University Of Health Sciences,

Bangalore.

Kindly accept the same and oblige.

Thanking you.

Yours faithfully,

Place: Mangalore.

Date : 17 .Nov. 09

Dr. KOMAL . G

Head Of Department

Dr. SUDHIR HEGDE MS,

Professor & Head, Dept. Of Ophthalmology

A.J. Insttitute Of Medical Sciences, Mangalore-04

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