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Trial registered on ANZCTR


Registration number
ACTRN12616001386426
Ethics application status
Approved
Date submitted
19/11/2015
Date registered
6/10/2016
Date last updated
6/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Diagnostic accuracy of Digital Retinal Photography (DRP) in screening for Retinopathy of Prematurity (ROP) by non- ophthalmologists-a prospective study.
Scientific title
Diagnostic accuracy of Digital Retinal Photography (DRP) as compared to Binocular Indirect Ophthalmoscope (BIO) examination in screening for Retinopathy of Prematurity (ROP) in preterm infants by non-ophthalmologists: a prospective study.
Secondary ID [1] 284432 0
nil
Universal Trial Number (UTN)
U1111-1155-6675
Trial acronym
WADROP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Retinopathy Of Prematurity 291636 0
Condition category
Condition code
Eye 292019 292019 0 0
Diseases / disorders of the eye
Reproductive Health and Childbirth 300347 300347 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible population:

'All preterm infants <31 weeks, regardless of weight' and 'All preterm infants <1250 grams, regardless of gestation'.
The digital imaging of the retina will be done by the DRP trained nurses using a device called RetCam 24 - 48 hours prior to or after the BIO examination. 5-6 images per eye will be taken the images will be uploaded onto the computer database by the nursing staff. The image acquisition takes 10-15 minutes. DRP images are done as per the screening schedule. From the database images will be sent to the ophthalmologists for interpretation.
Intervention code [1] 289182 0
Diagnosis / Prognosis
Comparator / control treatment
Binocular Indirect Ophthalmoscopy done by Ophthalmologists as per the standard protocol. It is a direct examination of the Retina by the specialists. BIO has been the gold standard diagnostic examination.
Control group
Active

Outcomes
Primary outcome [1] 291908 0
Ability to identify all infants with Referral warranting ROP ( RWROP)

(RW-ROP is defined as ROP of sufficient severity to require expert ophthalmologic opinion (1). Any Zone 1 disease (2). Any stage 3 or more diseases, (3). Presence of plus disease.

The findings of DRP will be compared with gold standard BIO assessment.
Timepoint [1] 291908 0
Endpoint will be when baby is eligible for discharge. ( Depending on the clinical condition)
Secondary outcome [1] 316399 0
Nil
Timepoint [1] 316399 0
Nil

Eligibility
Key inclusion criteria
All Preterm infants
Fullfilling any one of the following criteriae
1. All babies born <31 weeks, regardless of weight.
2. All babies born <1250 grams, regardless of gestation.
Minimum age
0 Hours
Maximum age
8 Weeks
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Failure to obtain informed consent.
Known ocular anomalies or infection
Other major congenital anomalies/syndromic

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 6001 0
King Edward Memorial Hospital - Subiaco

Funding & Sponsors
Funding source category [1] 292420 0
Government body
Name [1] 292420 0
Women and Newborn Health Services
Address [1] 292420 0
374, Bagot Road,
Women and Newborn Health Service
Subiaco, Perth 6008 WA
Country [1] 292420 0
Australia
Primary sponsor type
Government body
Name
Women and Newborn Health Serrvice
Address
374, Bagot Road,
Women and Newborn Health Service
Subiaco, Perth 6008 WA
Country
Australia
Secondary sponsor category [1] 291110 0
None
Name [1] 291110 0
Address [1] 291110 0
Country [1] 291110 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293883 0
Women and Newborn Health Service Ethics committee, WA Health
Ethics committee address [1] 293883 0
374, Bagot Road,

Subiaco

Perth

Western Australia

6008
Ethics committee country [1] 293883 0
Date submitted for ethics approval [1] 293883 0
09/09/2015
Approval date [1] 293883 0
06/10/2015
Ethics approval number [1] 293883 0
2014099

Summary
Brief summary
Retinopathy of Prematurity (ROP) is an eye disease which occurs in preterm infants. In severe cases, it can lead to blindness. Hence, preterm infants born at less than 31 weeks or birth weight less than 1250 grams are screened for ROP by ophthalmologists during their admission in the hospital. However, there are only limited number of Paediatric Ophthalmologists who are available to do ROP screening and treatment. With increasing number of preterm survival, ROP screening has increased the burden on already overworking ophthalmologists. Digital retinal photography (DRP) has theoretical advantages over Binocular Indirect Ophthalmoscope (BIO) because a trained non-ophthalmologist (e.g., neonatal nurse) can take the digital images and upload onto a secure server, so that the remotely located ophthalmologist can view and interpret. This has the potential to decrease the workload on ophthalmologists and even improve the outcomes for preterm infants. This technology also enables storage of the images for future reference which is not possible with the current screening with BIO.

Objectives:
The objective of this study is to measure the diagnostic accuracy of DRP compared to the standard BIO in diagnosing ROP.

Trial Plan:
The retinal images of preterm infants will be taken by trained neonatal nurses using the wide angle digital retinal camera and uploaded onto a secured pass word protected computer. These images will be sent to the ophthalmologists and reviewed by the remotely located ophthalmologist . The standard BIO examination will be done by another experienced ophthalmologist. This will enable us to study the feasibility and validity of the telemedicine approach in identifying the at risk infants who needs a referral to ophthalmologist (RW-ROP). This will be a prospective study involving eligible preterm infants who are admitted in our neonatal units.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47694 0
A/Prof Dr. Geoffrey Lam
Address 47694 0
Head Of the Department
Paediatric Ophthalmology
Roberts Road
Princess Margaret Hospital for Children
Subiaco
Perth WA 6008
Country 47694 0
Australia
Phone 47694 0
+61 8 9380 6044
Fax 47694 0
Email 47694 0
geofflam@wasquint.com.au
Contact person for public queries
Name 47695 0
Dr Sam E Athikarisamy
Address 47695 0
Neonatal Clinical care unit
King Edward Memorial Hospital for Women
Bagot Road
Subiaco
Perth 6008 WA
Country 47695 0
Australia
Phone 47695 0
+61 8 9340 1260
Fax 47695 0
Email 47695 0
Sam.Athikarisamy@health.wa.gov.au
Contact person for scientific queries
Name 47696 0
Dr Sam E Athikarisamy
Address 47696 0
Neonatal Clinical care unit
King Edward Memorial Hospital for Women
Bagot Road
Subiaco
Perth 6008 WA
Country 47696 0
Australia
Phone 47696 0
+61 8 9340 1260
Fax 47696 0
Email 47696 0
Sam.Athikarisamy@health.wa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary