Efficacy and Safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening (NCT05043077) | Clinical Trial Compass
CompletedPhase 4
Efficacy and Safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening
Greece83 participantsStarted 2021-09-07
Plain-language summary
The purpose is to test the hypothesis that microdrop instillation of combined phenylephrine 1.67% and tropicamide 0.33% eyedrops causes at least equal mydriasis compared with standard drop instillation of the same mydriatic regimen, which constitutes routine care for pupil dilation during retinopathy of prematurity (ROP) screening in our neonatal intensive care unit. Comparison, also, will be made to the subsequent adverse events and the drug concentration in peripheral blood samples.
Who can participate
Age range
30 Weeks – 36 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Preterm infants undergoing screening for ROP, i.e.
* infants with GA \< 32 weeks and/or BW \< 1501 grams
* infants of greater GA and BW with comorbidities, e.g. sepsis, prolonged need for oxygen supplementation etc., as recommended by the attending neonatologist
Exclusion Criteria:
* Unstable clinical condition
* Severe cardiovascular disease
* Congenital anomalies
* Clinical syndromes
* Inotropes' intake during the week prior to enrollment
* Traumatic apoptosis of the corneal epithelium
* Corneal ulcer
* Anatomical variations of the anterior segment
* Infants that are outpatients at the commencement of ROP screening
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mydriatic efficacy: millimeters of horizontal pupil diameter.
Timeframe: 45 minutes after the first drop instillation.