Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649513
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Long-term Ophthalmic Outcomes in Ex-premature Infants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Long-term Ophthalmic Outcomes in Ex-premature Infants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LTOO-XP
Brief Summary:
There is limited knowledge on ophthalmological outcomes in the adult population that was born prematurely This study aims to evaluate the ophthalmic outcomes of ex-premature infants that have reached adolescence or adulthood
Detailed Description:
Every year around 18000 children in the Netherlands are born prematurely which means that they were born before 37 weeks gestational age The WHO defines three different categories of prematurity moderate to late preterm 32-37 weeks very preterm 32-28 weeks and extremely preterm 28 weeks Preterm birth is associated with numerous health problems which can have both short-term and long-term consequences on the development of the child A relatively rare complication of very or extreme preterm birth is lifelong visual impairment or blindness due to retinal detachment as a result of prematurity retinopathy ROP ROP is a vasoproliferative condition that affects the vessels in the retina An inventory study shows that 305 children were diagnosed with ROP in the Netherlands in 2017 The majority of these children experienced spontaneous regression of the condition but 13 of cases required treatment to prevent retinal detachment In the long-term ROP predisposes for ocular conditions such as visual field abnormalities refractive error strabismus amblyopia glaucoma and retinal detachment However research also indicates that prematurity regardless of ROP diagnosis can also be associated with adverse ophthalmological outcomes such as refractive error strabismus amblyopia and cerebral visual impairment CVI Although there are various publications on the ophthalmological outcomes of ROP and prematurity at school-age less is known about these outcomes in the adult population This study aims to investigate the anatomy and functionality of the eye in ex-premature infants who were born between 1991 and 2006 In addition the differences in outcomes between ex-premature infants with and without ROP and the differences in outcomes between treated and spontaneously regressed ROP will be studied
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None