| CTRI Number |
CTRI/2017/02/007842 [Registered on: 13/02/2017] Trial Registered Retrospectively |
| Last Modified On: |
08/02/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Screening of retinopathy of prematurity |
|
Scientific Title of Study
|
Screening and result analysis of retinopathy of prematurity in premature and low birth weight neonates |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Payal Arora |
| Designation |
Resident Doctor, Department of Ophthalmology |
| Affiliation |
government Medical College, Bhavnagar |
| Address |
Room no. 504, PG2 hostel, Sir Takhtsinhji Hospital campus, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
07567871995 |
| Fax |
|
| Email |
payal.arora260291@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nilesh V Parekh |
| Designation |
M.S. (ophthalmology) FICO Professor & Head Department of Ophthalmology |
| Affiliation |
Government Medical College, Bhavnagar |
| Address |
22, VINAY, Behind Central Salt, Opposite New Filter Tank,
Bhavnagar
GUJARAT
364001
India |
| Phone |
09428408788 |
| Fax |
|
| Email |
drnvparekh@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nilesh V Parekh |
| Designation |
M.S. (ophthalmology) FICO Professor & Head Department of Ophthalmology |
| Affiliation |
Government Medical College, Bhavnagar |
| Address |
22, VINAY, Behind Central Salt, Opposite New Filter Tank,
GUJARAT
364001
India |
| Phone |
09428408788 |
| Fax |
|
| Email |
drnvparekh@hotmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT MEDICAL COLLEGE AND SIR TAKHTSINHJI HOSPITAL BHAVNAGAR. |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT MEDICAL COLLEGE AND SIR TAKHTSINHJI |
| Address |
DEPARTMENT OF OPHTHALMOLOGY GOVERNMENT
MEDICAL COLLEGE AND SIR TAKHTSINHJI HOSPITAL JAIL
ROAD BHAVNAGAR 364001 GUJARAT |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| PAYAL ARORA |
SIR TAKHTSINHJI HOSPITAL BHAVNAGAR |
DEPARTMENT OF
OPHTHALMOLOGY
GOVERNMENT
MEDICAL COLLEGE
AND SIR
TAKHTSINHJI
HOSPITAL, JAIL ROAD
BHAVNAGAR 364001
Bhavnagar
GUJARAT
Bhavnagar
GUJARAT |
07567871995
payal.arora260291@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HUMAN ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
PREMATURE AND LOW BIRTH WEIGHT NEONATES, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
1.00 Year(s) |
| Gender |
Both |
| Details |
Patients whose parents are giving written and
informed consent for examining their child.
New born of gestational age less than 34 weeks or birth weight less than or equal to 2000 g
Any baby of gestational age less than 37 weeks or birth
weight less than or equal to 2000 g with any of following
Sepsis
Acute respiratory distress syndrome
Multiple blood transfusions
Multiple births |
|
| ExclusionCriteria |
| Details |
Parents who are not giving written and informed
consent.
Patient having very poor general condition.
Patient having other congenital anomalies of eye. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence rate will be calculated
in different neonate groups. |
Incidence rate will be calculated
in different neonate groups. According to their gestational age. 36 week of gestational age will be landmark till that screening must be done. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/11/2015 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
• With written and informed consent of the parents
newborn will be examined.
• Detailed history will be taken specially birth weight,
gestational age, any complication during delivery.
• Both the eyes will be examined under torch light for
any gross anterior segment abnormality.
• If direct pupillary reflex is normal then both eyes will
be dilated using diluted Tropicamide(0.4%) +
Phenylephrine(2.5%) eye drops .
• Drops will be instilled three times 10 minutes apart. While instlling mydriatic eye drop pulse monitor
will be attached to look for pulse and blood
pressure of the child.
• Excess drops immediately blotted to decrease
systemic absorption and side effects. Retina of both eyes will be examined one by one
using sterile pediatric eye speculum after instilling
1 drop of topical anesthetic eye drop
(paracaine(0.5%)).
• Indirect ophthalmoscopy will be performed using
zeiss indirect ophthalmoscope with 28 D lens.
• All the quadrants of both the eyes will be
examined and charted. |