Erasmus MC
Rotterdam, South Holland, 3015 GD, Netherlands
Location contact
Angela Arends-Tjiam, Dr
CONTACT
Angela Arends-Tjiam, Dr
CONTACT
Lizanne Derks, BSc
CONTACT
Lizanne Derks, BSc
CONTACT
NCT Number: NCT06649513
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.
Trial opening soon.
Get Notified16 year and older
All sexes
Observational
Rotterdam, South Holland, 3015 GD, Netherlands
Angela Arends-Tjiam, Dr
CONTACT
Angela Arends-Tjiam, Dr
CONTACT
Lizanne Derks, BSc
CONTACT
Lizanne Derks, BSc
CONTACT
Every year, around 18.000 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Mydriatic + cycloplegic eye drops are given to measure refractive error and to image the full retina.
Time frame: The primary outcome measure will be assessed at one single visit to Erasmus MC. This one-off measurement will not be repeated, nor is there a specific time-frame for this measurement.
Measured with ETDRS chart. Expressed in Logarithm of the Minimum Angle of Resolution (LogMAR)
Time frame: The secondary outcome measures will be assessed at one single visit to Erasmus MC. These one-off measurements will not be repeated, nor are there a specific time-frames for these measurements.
Contact information is provided by the study sponsor or research team.
Angela Arends-Tjiam, Dr
CONTACT
Lizanne Derks, BSc
CONTACT
Erasmus Medical Center
Other
Acronym: LTOO-XP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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