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
| ISRCTN | ISRCTN12504814 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12504814 |
| Integrated Research Application System (IRAS) | 346891 |
| Central Portfolio Management System (CPMS) | 70694 |
| Protocol serial number | Sponsor Reference: GN23OP457P |
| Sponsor | NHS Greater Glasgow and Clyde |
| Funder | Fight for Sight |
- Submission date
- 07/10/2025
- Registration date
- 07/10/2025
- Last edited
- 13/11/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Neonatal Diseases
Plain English summary of protocol
Background and study aims
Retinopathy of Prematurity (ROP) is an eye condition that can cause blindness in premature babies. It happens when the blood vessels in the back of the eye (the retina) don’t grow properly after birth. In some cases, they grow in a chaotic way and cause scarring, which can lead to permanent vision loss. In high-income countries, babies at risk are regularly screened and treated, but in lower-income countries, this isn’t always possible, and many children lose their sight.
This study aims to find better ways to predict which babies are at risk of developing serious ROP. Researchers will look at proteins found in babies’ tears and measure how their eyes respond to light. By comparing these results with standard eye exams, they hope to discover new, less invasive ways to detect and treat ROP early.
Who can participate?
Babies born very early (before 28 weeks of pregnancy) or with a very low birth weight (under 1051 grams) may be eligible to take part in the study. There are some medical reasons why certain babies might not be included.
What does the study involve?
Researchers will collect small samples of tears from participating babies to look for specific proteins linked to ROP. They will also use a gentle test called an electroretinogram (ERG), which measures how the retina responds to light. This is done using soft electrodes placed around the baby’s eye while they are in their incubator. The study will also collect basic medical information like age, gender, ethnicity, and oxygen use.
What are the possible benefits and risks of participating?
There is no direct benefit to the babies taking part, but the study could help improve how ROP is detected and treated in the future. The procedures used are safe and non-invasive, and the team will take great care to ensure the babies are comfortable throughout.
Where is the study run from?
The study is led by NHS Greater Glasgow and Clyde, with support from NHS Lanarkshire, Manchester University NHS Foundation Trust, and Birmingham Women’s NHS Foundation Trust (UK).
When is the study starting and how long is it expected to run for?
February 2025 to September 2027
Who is funding the study?
Fight for Sight (UK)
Who is the main contact?
Dr Anne Cees Houtman, annecees.houtman2@nhs.scot
Contact information
Public, Scientific, Principal investigator
Paediatric Eye Clinic
Royal Hospital for Children
1345 Govan Rd
Glasgow
G51 4TF
United Kingdom
| Phone | +44 141 201 000 |
|---|---|
| annecees.houtman2@nhs.scot |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational longitudinal prospective multi-centre study |
| Secondary study design | Longitudinal study |
| Study type | Participant information sheet |
| Scientific title | Tear proteomics and electrophysiology in infants at risk of retinopathy of prematurity - TEARDROPS (TEAr pRoteomics Deduce ROP Stage) |
| Study acronym | TEARDROPS |
| Study objectives | Principle Objective: To identify proteins in the tears of premature babies which can predict ROP requiring treatment Secondary Research Objectives: 1. To identify a key age window where changes in tear proteins predict the onset of treatment warranted ROP (stage 1) 2. To test the diagnostic accuracy of a single (or paired) tear sample collected in that key age window from a second group of babies (stage 2) 3. To establish whether the electroretinogram (ERG) is feasible and/or useful as a potential predictor of ROP 4. To use the protein analysis to enhance understanding of ROP pathophysiology |
| Ethics approval(s) |
Approved 09/07/2025, South Central - Oxford C Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 2071048271; oxfordc.rec@hra.nhs.uk), ref: 25/SC/0158 |
| Health condition(s) or problem(s) studied | Retinopathy of prematurity |
| Intervention | In phase 1: tear samples will be collected from premature babies +/- 24 hours of ROP screening. Samples will be collected from both eyes at every screening and stopped when screening completes. Tear samples will be collected via schrimer strips under the eyelid for a maximum of five minutes. In phase 2: the sample collection method is the same. However, babies will only have 1 or 2 samples taken from each eye over a predefined gestational age following data analysis from phase 1. No speculum is used for sample collection. No topical medication is used for sample collection. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. A large tear proteomic dataset from a cohort of over 110 premature infants at very high risk of ROP. Data will be collected via patient notes at each tear sample collection. Tear sample collection will happen +/- 24 hours of planned ROP screening. Tear samples will be collected using a Schrimer strip for a maximum or 5 minutes, or until 5mm of strip wetting has been achieved. Tear strips will be placed under the eyelid of the participant. No anaesthetic or speculum will be used. Tear strips will then be placed into an Eppendorf container containing SDT buffer. Eppendorf containers will then be stored at (-20 degree Celsius) until sent for mass spectrometry testing. Consultant Ophthalmologists will record the ROP findings at each screening. ROP findings will be recorded as per standard international guidelines. |
| Key secondary outcome measure(s) |
1. Possible identification of a tear proteomic biomarker, with a critical age window, for treatment-warranted ROP. As above. |
| Completion date | 12/09/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 0 Weeks |
| Upper age limit | 28 Weeks |
| Sex | All |
| Target sample size at registration | 110 |
| Key inclusion criteria | Infants meeting G-ROP criteria (gestational age <28 weeks OR birth weight <1051g). These criteria, stricter than the UK ROP-screening guidelines (gestational age <31 weeks, birth weight <1051g) increase the likely proportion of infants developing treatment-warranted ROP to 50%. |
| Key exclusion criteria | 1. Chronic infectious/ inflammatory conjunctivitis 2. Hydrocephalus (a ventricular index on cranial ultrasound 4mm above the 97th gentile for gestational age - Leaven Index) 3. Congenital bilateral ocular anomaly |
| Date of first enrolment | 14/10/2025 |
| Date of final enrolment | 12/09/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
- Scotland
Study participating centres
Glasgow
G51 4TF
Scotland
Wishaw
ML2 0DP
Scotland
Manchester
ML2 0DP
Scotland
Birmingham
B15 2TG
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available on request from Chief Investigator Dr Anne Cees Houtman (annecees.houtman2@nhs.scot) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
13/11/2025: Internal review.
07/10/2025: Trial's existence confirmed by Vision Foundation Fight for Sight.
