Skip to content

Diagnostic accuracy of Digital Retinal Photography (DRP) in screening for Retinopathy of Prematurity (ROP) by non- ophthalmologists-a prospective study.

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001386426
Acronym
WADROP
Enrollment
189
Registered
2016-10-06
Start date
2015-10-26
Completion date
2016-03-14
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

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.

Sponsors

Women and Newborn Health Serrvice
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to 8 Weeks
Healthy volunteers
No

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.

Exclusion criteria

Failure to obtain informed consent. Known ocular anomalies or infection Other major congenital anomalies/syndromic

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 17, 2026