Tear proteomics and electrophysiology in infants at risk of ROP v 1.0
Research type
Research Study
Full title
Tear Proteomics and Electrophysiology in Infants at Risk of Retinopathy of Prematurity - TEARDROPS (TEAr pRoteomics Deduce ROP Stage)
IRAS ID
346891
Contact name
Anne Cees Houtman
Contact email
Sponsor organisation
NHS Greater Glasgow & Clyde Research & Innovation
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Retinopathy of prematurity (ROP) is a potentially blinding condition for prematurely born babies. ROP interrupts development of the blood vessels of the retina (the light-sensitive neural layer at the back of the eye), in the first weeks of life. Later,this may cause a surge of chaotic growth of blood vessels, which can result in scarring and blindness.
Routine risk-management of ROP involves a labour-intensive screening programme by ophthalmologists to identify earlier stages of ROP when treatment is effective, but these examinations cause distress to the babies.
We think that the tears of premature babies may contain proteins which indicate whether ROP will be severe enough to require treatment. We have published a feasibility study that showed that tear samples of premature babies are easily sampled without causing distress. Mass spectrometry can demonstrate thousands of proteins in these very small samples.
We would now like to repeat the sampling on a much larger group of premature infants who are at high risk (about 50%) of developing sight-threatening disease.
In the first phase we will collect tears several times from each baby (during routine ROP-screening) to understand how the protein concentrations change over time and aim to identify key proteins and a key time window.
Babies will be grouped as those who developed ROP needing treatment and those who did not. We will then compare the changes in the tear proteins and routinely collected clinical information about any ROP between the groups.In the second phase, we will collect tear samples from each baby during the determined key time window and assess how well their tear proteins identify ROP which needs treatment.
On one site, we will also record an electroretinogram, a non-invasive electrical test of the retina, to see whether this provides additional information on development of ROP.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
25/SC/0158
Date of REC Opinion
6 Jun 2025
REC opinion
Further Information Favourable Opinion