Clinical trial NCT06649513: Long-term Ophthalmic Outcomes in Ex-premature Infants
Official title: Long-term Ophthalmic Outcomes in Ex-premature Infants
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Retinopathy of Prematurity (ROP)
Premature Birth
Keywords: Retinopathy of Prematurity
Preterm birth
Visual acuity
Visual outcomes
Long term outcomes
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2024-10-18
Enrollment: 210
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premature patients who were eligible for ROP screening, who were admitted to Erasmus MC between 1991 and 2007.

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 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.

Eligibility criteria: Inclusion Criteria:

* Subjects eligible for ROP screening, and admitted to Erasmus MC between 1991 and 2007.

Exclusion Criteria:

* Subjects born after 2008,
* Subject has passed away before the start of the study
* Subject resides outside of the Netherlands
* Subject has a physical or mental disability that makes it impossible to participate in a routine eye exam, or has a disability that classifies the subject as an incapacitated adult.

Primary outcomes:
measure: Visual acuity
timeFrame: 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.
Secondary outcomes:
measure: Biometric, refractive, fundus and Optical coherence tomography (OCT) data.
timeFrame: 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.
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid-Holland
Study officials:
References: