To Determine the Normal Fetal Ocular Size & Interocular Distance Between 18-20 Weeks Of

SYNOPSIS

TO DETERMINE THE NORMAL FETAL OCULAR SIZE & INTEROCULAR DISTANCE BETWEEN 18-20 WEEKS OF GESTATION

DR. MANISH GULIA

FOR REGISTRATION OF SUBJECT FOR DISSERTATION

Rajiv Gandhi University of Health Sciences Karnataka, Bangalore

In Partial Fulfillment of Regulations In Regard for the award of Masters Degree in radiodiagnosis

Department of Radiodiagnosis and Imaging Command Hospital (Air Force) Bangalore-560007

Rajiv Gandhi University of Health Sciences Karnataka, Bangalore

Annexure – II

1 PERFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

8. List of references As per APPENDIX – VIII

9. Signature of the candidate

10. Remarks of the guide The study has research potential. Adequate number of subjects will be available. The required infrastructure is available at this hospital

11. 11.1 Name and designation of GP CAPT H SAHNI the guide SR ADV & HOD DEPARTMENT OF RADIODIAGNOSIS AND IMAGING CHAF, BANGALORE

11.2 Signature of Guide

11.3 Head of the Department GP CAPT H SAHNI SR AD & HOD DEPARTMENT OF RADIODIAGNOSIS AND IMAGING CHAF, BANGALORE

11.4 Signature of HOD

2 12. 12.1 Remarks of the Principal

12.2 Signature

AVM RAJVIR BHALWAR COMMANDANT AND PRINCIPAL COMMAND HOSPITAL AIR FORCE BANGALORE

3 Appendix – I

NEED FOR STUDY

Abnormal ocular size and interoccular distance are associated with congenital anomalies. Screening by ultrasound in antenatal period can identify orbital defects such as hypertelorism and hypotelorism. This can be done by the measurements of Interocular distance. These measurements are also useful for the estimation of gestational age. To date, there have been only limited studies to evaluate fetal ocular distance & none could be found done in Indian population. The purpose of the present study is to construct reference ranges for fetal interocular distance (IOD) & ocular size during 18-20 weeks gestation and to evaluate the relationships between these data and gestational age & any associated fetal anomaly detected

4 Appendix – II

REVIEW OF LITERATURE

1. As per WHO Congenital anomalies (also referred as birth defects) affect approximately 1 in 33 infants and result in approximately 3.2 million birth defect-related disabilities every year Ultrasonography is the imaging modality of choice for antenatal detection of anomalies & 18-22 weeks is the time recommended for antennal detection of anomaly by US scan. Abnormal ocular size and interocular distance are associated with congenital anomalies . Sonographic evaluation of the fetal orbits is best obtained in axial/coronal views . Size, shape & Interocular distance is taken during the antenatal anomaly scanning & it should be with in the normal range [1]. Hypotelorism –defined as an abnormally small distance between the orbits & is often associated with other anomalies such as Holoprosencephaly, chromosomal anomalies (trisomies 13,18&21) & various syndromes (Langer Giedion syndrome etc)[1] Hypertelorism- defined as widely spaced eyes, may be associated with defect in embryological development , chromosomal anomalies (trisomies 9p, 45,XO) Single gene disorders (Apert , Crouzon or Noonan syndrome) , developmental abnormalities (craniosynostosis , agenesis of corpus collosum etc) or may be associated with teratogens (Dilantin, Valproate)[1]

2. Ocular and orbital malformations (anophthalmia, microphthalmia, hypo- and hypertelorism) are often principal signs of generalised syndromes, hence orbital biometry is helpful for a detailed prenatal investigation of the fetal face [2].

3. Anomalies of the central nervous system, particularly holoprosencephaly, are typically associated with very severe facial abnormalities. Facial anatomic characteristics and measurements of orbital diameter

5 can easily be obtained in early pregnancy which can predict abnormal head development and could raise suspicion of an abnormal fetal karyotype [3].

4. A study derived reference value of fetal IOD and BOD with GA, ( both fetal IOD and BOD in 15-40 weeks ) and found a linear relationships. The authors found shortening in IOD and BOD in some cases of fetal aneuploidy. The study provided data on normal IOD and BOD in local population in Thialand. As per the study the nomograms might be helpful in the detection of fetal hypertelorism and hypotelorism[4]

5. Fetal ocular biometry has been previously established and reported as a means of detecting fetal anomalies. The potential value of this measurement is illustrated in a case of thanatophoric dysplasia. ( Thanatophoric dysplasia is a severe skeletal disorder characterized by a disproportionately small ribcage, extremely short limbs and folds of extra skin on the arms and legs.)[5]

However no Indian data /reference table is found documenting the normal ocular size & interocular distance on antenatal USG scanning

6 Appendix - III

OBJECTIVE OF STUDY

1. To determine the normal range of interocular distance & ocular size in fetus between 18-20 week of gestation

2. To evaluate the relationships between these data and gestational age & any associated fetal anomaly .

7 Appendix – IV

MATERIALS AND METHODS

1. Source of Data The proposed study will be conducted at Command Hospital Air Force Bangalore. All cases presenting for antenatal scan, with gestational age between 18-20 week will be taken up for study. Cases will be included in the study after taking consent.

Inclusion Criteria a.) Singleton live pregnancy b.) No congenital anomaly detected on antenatal ultrasound c.) Fetus with gestational age between 18-20 weeks d.) After birth, the growth and attainment of milestones is normal till 3 month of age

Exclusion Criteria

a.) Fetus with congenital anomaly on USG scan b.) Maternal hypertension, diabetes mellitus, thyroid dysfunction & any chronic illness in mother c.) Any fetus later found to have any malformation or congenital anomaly at birth or till 3 months of age.

2. Method of Collection of Data:

The measurements of interocular distance & ocular size will be taken using trans abdominal ultrasonography in coronal / axial views. Thereafter the outcome of pregnancy will be documented & normal physical & mental development of the newborn will be monitored till 3 month of age. Infant growth should commenuserate with attainment of normal milestones till 3 month of age (Confirmed physically / telephonically)

Total number of cases - 100.

8 3. Study duration

Between 2013 to 2016

8. Data Collection As per proforma (APPENDIX V)

9. Statistical Analysis Mean, Median, Range and standard Deviation

10. Does the study require any investigations or interventions to be conducted on patients or animals? If so, please describe briefly Yes. Trans abdominal ultrasonography, without any medication

11. Has the ethical clearance been obtained from your institution. Yes

9 Appendix V

PROFORMA 1. Demographic details Personal No. Name OPD/Inpatient No Age Sex Unit Date

Contact no. - Email Id –

2. History of Maternal health – HTN / DM / Any Chronic Illness - YES/NO (if YES please specify)

3. 1st Trimester scan report – Done on –

Gestational Age (as per USG) -

Anomaly detected - YES/NO (if YES please specify)

3. Transabdominal USG scan at POG (as per dating scan done in 1st trimester) Date & time POG (in weeks) IOD OCULAR SIZE Right Left

4. Follow up comments a.) At birth –

b.) At 3 Months of Age -

10 Appendix VI

CERTIFICATE FROM THE HEAD OF THE INSTITUTION

Permission is hereby accorded to the student Dr Manish Gulia , to undergo MD(Radio diagnosis) course being conducted at Command Hospital (Air Force) Bangalore affiliated to Rajiv Gandhi University of Health Sciences Karnataka, Bangalore commencing from Jul 2011 under the guidance of Gp Capt (Dr) Hirdesh Sahni, Sr Advisor & HOD, Dept of Radio diagnosis, Command Hospital (Air Force) Bangalore- 560007

COMMANDANT & PRINCIPAL COMMAND HOSPITAL BANGALORE-07

11 CERTIFICATE FROM ETHICAL COMMITTEE

1. The committee has examined the scope including the aim, need, objectives, and method of data collection and human/animal intervention of the following study to be carried out by Dr Manish Gulia under the guidance of Gp Capt (Dr) Hirdesh Sahni the title of which is “TO DETERMINE THE NORMAL OCULAR SIZE & INTEROCULAR DISTANCE IN FETUS BETWEEN 18-20 WEEKS OF GESTATIONAL AGE”.

2.The committee has no objection for undertaking this study at Command Hospital (Air Force), Bangalore.

(Salini Chaudhary) (S Kaistha) (SK Jha) (SC Dash) (MS Prakash) (H Sahni) Sq Ldr Wg Cdr Col Col Brig Gp Capt OIC Legal cell Rep of AWWA OIC Prof &HOD Prof &HOD OIC AFMRC Member Member PG Cell Surgery Medicine Member Secretary Member Member Member

12 (Mrs. Vasantha Kishore) (Dr V Sinha) Counsellor Scientist ‘D’ Physiologist E- support Memeber Member

(MK BEDI) Air Cmde AOC MTC CHAIRMAN ETHICAL COMMITTEE COMMAND HOSPITAL (AIR FORCE) BANGALORE – 560007

CERTIFICATE OF ACCEPTANCE BY THE GUIDE

I Gp Capt (Dr) Hirdesh Sahni Sr Adv, Professor & HOD (RadioDiagnosis) Command Hospital (Air Force) Bangalore, hereby certify that I accept Dr Manish Gulia as a candidate for MD (Radio Diagnosis) course. The title of the dissertation is as follows:-

“TO DETERMINE THE NORMAL OCULAR SIZE & INTEROCULAR DISTANCE IN FETUS BETWEEN 18-20 WEEKS OF GESTATIONAL AGE ”.

13 He will be under my guidance during the entire period of his study and thesis work.

Date: Gp Capt (Dr) Hirdesh Sahni Place: MD DNB DM (Neuroradiology) Sr Adv , Professor & HOD Deptt of Radiodiagnosis & Imaging CHAF Bangalore-07

Appendix-VII

Study Information Sheet for Patients

Title: To determine the normal fetal ocular size & interocular distance between 18-20 weeks of gestation

Resident / Principal worker – Dr Manish Gulia Guide - Gp Capt Hirdesh Sahni , HOD & Sr Adv , Radiodiagnosis

PURPOSE OF THE STUDY The purpose of the present study is to construct reference ranges for fetal interocular distance (IOD) & ocular size during 18-20 weeks gestation and to evaluate the relationships between these data and gestational age & any associated fetal anomaly detected and to obtain an Indian standard.

Procedure (a) Informed consent will be obtained prior to the patient being subjected to any diagnostic procedure. (b) The measurements of interocular distance & ocular size will be taken using trans abdominal ultrasonography in coronal / axial views. (c) Thereafter the outcome of pregnancy will be documented & normal physical & mental development of the newborn & attainment of normal milestones till 3 month of age will be Confirmed physically / telephonically

POTENTIAL RISK AND DISCOMFORT None identified for USG .

Confidentiality All information that patients provide during the study will be used for study purpose and will not be communicated to others.

Contacts If you have any further questions or any time during the course of the study you feel that you need additional information about any procedure, you can contact the following: Dr Manish Gulia Resident Dept of Radiodiagnosis Command Hospital Air force Banglore -560007 Mob :- 9632467733

Consent Form (Study Title: To determine the normal fetal ocular size & interocular distance between 18-20 weeks of gestation.)

15 ______(Patient Particulars) has been fully informed of the nature and purpose of this study. Details of the procedures involved like Ultrasonography have been explained. All queries raised by the patient have been answered to the best of my ability. A signed copy of this form will be made available to the patient.

Resident Signature: Date:

I have been fully informed of the above noted study with its possible benefits, risks and consequences. I hereby agree to participate in this investigation. I furthermore recognize the fact that I am free to withdraw this consent and to discontinue my participation in this project at any time without prejudice to my care. I further consent to this data being used for research and /or publication provided confidentiality is maintained.

Signature :- Name :- Date :-

Appendix-VIII

16 REFERENCES

1. Text book of diagnostic ultrasound by Carol M Roumack , Stephanie R Wilson , J William Charboneau & Deborah Levine –Chapter 33 –The Fetal face & Neck

2. Study title [Orbital diameter, inner and outer orbital distance. A growth model of fetal orbital measurements]. Merz E, Wellek S, Püttmann S, Bahlmann F, Weber G with Ultraschall in Med 1995; 16(1): 12-17 , DOI: 10.1055/s-2007-1003230

3. Study title [Early Transvaginal Fetal Orbital Measurements A Screening Tool for Aneuploidy?] - By Paolo Rosati, MD, Lorenzo Guariglia, MD published in 2003 in J Ultrasound Med 22:1201–1205, 2003 Journal of the American Institute of Ultrasound in Medicine

4. Study title [Fetal Ocular Distance in Normal Pregnancies] By-Kanchapan Sukonpan MD*, Vorapong Phupong MD*-* Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, Bangkok -study published in 2008 - J Med Assoc Thai 2008; 91 (9): 1318-22

5. Study title [The binocular distance: a new way to estimate fetal age] Jeanty P, Cantraine F, Cousaert E, Romero R, Hobbins JC.. Published in J Ultrasound Med 1984; 3: 241-3