RecruitingObservational

The investigation of eye tear film proteins to see if there is an association with the stage of an eye condition called Retinopathy of Prematurity (ROP) which can occur in some premature babies; and the investigation of eye nerve development in these babies

This study is investigating new ways to detect and understand an eye condition called Retinopathy of Prematurity (ROP) in premature babies. ROP can sometimes cause vision problems or blindness if not caught early. Currently, babies at risk have regular eye checks, but this study aims to find less invasive and potentially earlier ways to spot the condition. Researchers will gently collect tiny tear samples from premature babies to look for specific proteins. They will also use a soft, gentle test that measures how the eye responds to light. By comparing these new tests with standard eye exams, the hope is to develop better tools to predict and manage ROP, helping to protect the sight of these vulnerable babies.

At a glance

Status

Recruiting

Sponsor

NHS Greater Glasgow and Clyde

Enrolment target

110

Start

14 Oct 2025

Estimated completion

12 Sep 2027

Retinopathy of prematurity

What is this study about?

This study is all about understanding and detecting an eye condition called Retinopathy of Prematurity, or ROP. This condition can affect babies who are born very early. In these babies, the tiny blood vessels at the back of their eyes, called the retina, might not grow correctly after birth. Sometimes, they can grow in a jumbled way, which can lead to scarring and, in rare cases, cause permanent vision loss.

Currently, expert eye doctors regularly check babies at risk to catch ROP early. While effective, these check-ups can be stressful for tiny babies and their parents. This study hopes to find new, gentler ways to identify babies who might be at higher risk of developing severe ROP. This could mean fewer uncomfortable exams for babies and a chance to intervene sooner if needed.

The researchers will be looking at two main things: tiny proteins found in a baby's tears, and how their eye reacts to light. By comparing these new tests with the current methods of checking babies' eyes, they hope to discover better and less invasive ways to predict which babies need the most careful monitoring for ROP. Ultimately, the goal is to improve how we protect the sight of premature babies.

Key takeaways

The study aims to find new, gentler ways to detect ROP in premature babies.
It involves collecting tear samples and performing a gentle eye response test.
No direct benefit for participating babies, but could help future babies.
Procedures are safe and designed to be comfortable for your baby.
Participation is voluntary and will not affect your baby's care.

Who may be eligible?

This study is looking for babies who were born very early or had a very low birth weight. Specifically, babies born before 28 weeks of pregnancy, or those who weighed less than 1051 grams at birth, might be able to take part.

There are a few reasons why a baby might not be able to join the study. For example, if a baby has a long-term eye infection or inflammation, or a brain condition called hydrocephalus, they might not be included. Also, babies with certain eye problems they were born with might not be suitable.

It's important to remember that the research team will carefully check if your baby can participate once you've expressed interest. This is to make sure the study is safe and suitable for them.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Was your baby born before 28 weeks of pregnancy?
Did your baby weigh less than 1051 grams at birth?
Does your baby currently have a severe eye infection or inflammation?
Does your baby have hydrocephalus (a specific brain condition)?
Does your baby have any eye problems they were born with?

Answer every question to see your result.

What does participation involve?

If your baby takes part in this study, the researchers will collect small samples of tears from their eyes. This will be done gently around the time of their regular eye checks for ROP. They will also use a mild test called an electroretinogram (ERG). This involves placing soft pads around your baby's eye while they are cosy in their incubator, to measure how their eye responds to light. These procedures are designed to be safe and as comfortable as possible for your baby.

The study will also gather some basic health information about your baby, such as their age, gender, background, and how much oxygen they might be receiving. There won't be any extra hospital visits just for the study, as the samples and tests will be done during your baby's existing care. The study is expected to run from February 2025 until September 2027.

Potential risks and benefits

There is no direct medical benefit to your baby by taking part in this study. However, the information gathered could greatly help other premature babies in the future by improving the ways ROP is detected and treated. The procedures used, collecting tear samples and the eye response test, are considered safe and non-invasive. The research team will take great care to ensure your baby is comfortable throughout. Remember, taking part in any study is entirely voluntary, and you are free to withdraw your baby from the study at any time without affecting their medical care.

Locations (4)

Royal Hospital for Sick Children (Glasgow) (3 sites in NHS GGC)
City only
Glasgow, Scotland
University Hospital Wishaw
Approximate
Wishaw, Scotland
Saint Mary's Hospital - (Manchester University NHS Foundation Trust (MFT) - 3 sites)
City only
Manchester, Scotland
Birmingham's Women Hospital ( Birmingham Women's NHS Foundation Trust) (+ peripheral sites within Trust)
City only
Birmingham, England

Common questions

What is Retinopathy of Prematurity (ROP)?

ROP is an eye condition that can affect premature babies, where the blood vessels in their eye don't grow properly, potentially causing vision problems.

Will my baby get special treatment by joining the study?

No, your baby will receive the same high standard of medical care as all other premature babies. The study is for research purposes, not for direct treatment.

Are the tests painful for my baby?

The researchers will use gentle methods to collect tear samples and perform the eye response test, aiming to keep your baby as comfortable as possible.

How long will my baby be involved in the study?

The study involves collecting tear samples and performing the eye test around the time of your baby's scheduled ROP screening. It's not a continuous involvement over a long period.

Who is funding this research?

The study is being funded by Fight for Sight, a UK charity dedicated to preventing sight loss.

How to find out more

Anne Cees Houtman

annecees.houtman2@nhs.scot +44 141 201 000 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.