Babies in Glasses; a Feasibility Study. (NCT05048550) | Clinical Trial Compass
UnknownNot Applicable
Babies in Glasses; a Feasibility Study.
United Kingdom55 participantsStarted 2021-09-09
Plain-language summary
This is a feasibility study to begin investigating the possibility that early use of near vision glasses will improve vision in infants at risk of Cerebral Visual Impairment (CVI), leading to further improvement in other areas of development. This active intervention, starting at either 2 or 4 months of age (depending on randomisation), could be more effective than waiting until a problem is detected before giving glasses.
As this is a feasibility study, the investigators are looking at a small sample of babies (n=75) to see whether their parents/carers are willing to take part in a 3-arm study comparing two differently timed interventions to a control group, as well as looking at different aspects of the research plan in preparation for a larger final study.
Who can participate
Age range
8 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
. All term infants undergoing therapeutic hypothermia for hypoxic ischaemic encephalopathy (HIE).
. All preterm infants born at \<29 weeks gestational age.
Exclusion criteria
. Infants that are still an inpatient at 8 weeks corrected gestational age.
. Ocular exclusion criteria: children with unrelated congenital or developmental ocular abnormality such as cataract requiring surgery, genetic retinal disease, coloboma. Retinopathy of prematurity will not be an exclusion criterion.
. Infants with high refractive error (more than -6.00D spherical equivalent or +8.00D spherical equivalent).
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
The acceptance of randomisation
Timeframe: 10 months
Trial details
NCT IDNCT05048550
SponsorGreat Ormond Street Hospital for Children NHS Foundation Trust