Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care (NCT07738874) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care
United States175 participantsStarted 2026-07-01
Plain-language summary
Retinopathy of prematurity (ROP) is a disorder of development of the retina and its vasculature that can impact vision in vulnerable preterm neonates for a lifetime. A major barrier to improving ROP outcomes is the lack of easy access and low stress means to obtain objective measures of ROP disease severity across the retina in these infants. The long-term goal of this program is to provide information which will improve preterm infant health and vision via objective bedside imaging and analysis that characterizes retina-wide ROP level of disease, its response to treatment and development, and to rapidly translate this for better early intervention and improved future vision care.
Who can participate
Age range
0 Days – 9 Months
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:
* Health care provider, knowledgeable of protocol, agrees that study personnel could contact the Parent/Legal guardian
* Parent/Legal Guardian is able and willing to consent to study participation for the infant
* Infant meets the American Association of Pediatrics eligibility of ROP screening, and is age \< 35 weeks postmenstrual age at first visit
* Infants transferred to nursery for ROP treatment (some participants)
Exclusion Criteria:
* Participant or Parent/Legal Guardian unwilling or unable to provide consent
* Adult participant or infant/child has a health or eye condition that preclude eye examination or retinal imaging (e.g. corneal opacity such as with Peter's anomaly or cataract)
* Infant has a health condition, other than prematurity, that has a profound impact on brain development (e.g. anencephaly)
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
Sensitivity and specificity of ultra-widefield OCT vs bionocular indirect ophthalmoscopy or fundus photograph to identify referral-warranted retinopathy of prematurity