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

Tear proteomics and electrophysiology in infants at risk of retinopathy of prematurity - TEARDROPS (TEAr pRoteomics Deduce ROP Stage)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN12504814

Enrollment

110

Registered

2025-10-07

Start date

2025-10-14

Completion date

Unknown

Last updated

2025-11-24

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

Conditions

Retinopathy of prematurity Neonatal Diseases

Interventions

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 s

Eligibility

Sex/Gender

All

Age

0 Weeks to 28 Weeks

Inclusion criteria

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%.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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. 2. Correlations of ROP clinical findings with tear proteomic changes. Tear samples will be analysed at the end of phase 1 of the study via mass spectrometry at a University of Glasgow laboratory. All samples will be transferred to the lab at the end of phase 1. Given samples will have been collected over varying gestational ages, we will review tear mass spectrometry results to see if there is a peak in any particular molecules. We will use data analysis from phase 1 to guide the gestational age of sample collection in phase 2 of the study. Tear samples will be collected in the same way. Alongside this, we will review ROP fundus screening findings.	—

Measure

Time frame

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. 2. Correlations of ROP clinical findings with tear proteomic changes. Tear samples will be analysed at the end of phase 1 of the study via mass spectrometry at a University of Glasgow laboratory. All samples will be transferred to the lab at the end of phase 1. Given samples will have been collected over varying gestational ages, we will review tear mass spectrometry results to see if there is a peak in any particular molecules. We will use data analysis from phase 1 to guide the gestational age of sample collection in phase 2 of the study. Tear samples will be collected in the same way. Alongside this, we will review ROP fundus screening findings.

—

Secondary

Measure	Time frame
1. Possible identification of a tear proteomic biomarker, with a critical age window, for treatment-warranted ROP. As above.	—

Countries

England, Scotland, United Kingdom

Contacts

Public ContactAnne Cees Houtman

annecees.houtman2@nhs.scot+44 141 201 000

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026