Primary Objective: Compare visual acuity between adults born prematurely and adults of general population born at full term.Secondary Objective(s): o Compare other anatomical and functional ocular outcomes (retina, macula thickness, refraction,…
ID
Source
Brief title
Condition
- Eye disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is best corrected visual acuity (VA) in LogMAR.
Secondary outcome
Secondary study parameters include:
• Refraction
• Axial eye length
• Intra-ocular pressure (IOP)
• Anterior chamber depth
• Macula thickness
• Lens thickness
• Presence of ophthalmological diagnoses such as amblyopia or strabismus
• Visual field abnormalities
• Anatomical abnormalities of the retina (OCT images)
• Relevant (ophthalmological) medical history/ophthalmological diagnoses in the
past
• Self-reported health/activity (questionnaire)
Background summary
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
retinopathy of prematurity (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 of ex-prematures, especially relative to the general population of
adults without a history of preterm birth. In this study we want to investigate
the anatomy and functionality of the eye in adults who were born preterm
between 1991 and 2006, and make the comparison with ocular outcomes in the
general population of adults born at full term. In addition, we will
investigate differences in outcomes between adults born prematurely with and
without a history of ROP, and investigate differences in outcomes between
treated and spontaneously regressed ROP.
Study objective
Primary Objective:
Compare visual acuity between adults born prematurely and adults of general
population born at full term.
Secondary Objective(s):
o Compare other anatomical and functional ocular outcomes (retina, macula
thickness, refraction, axial eye length, intra-ocular pressure (IOP), anterior
chamber depth, strabismus, amblyopia) between adults born prematurely and
adults of general population born at full term.
o Compare anatomical and functional ocular outcomes of adults born prematurely
with and without any form of ROP.
o Compare anatomical and functional ocular outcomes of adults born prematurely
with spontaneously regressed ROP versus treated ROP.
Study design
This study is designed as a comparative cross-sectional study. We invite adults
who were born prematurely between 1991 and 2006 and were admitted to the
neonatology unit at Erasmus MC for a scheduled eye exam at our ophthalmology
department. Outcomes of this exam will then be analyzed and compared to the
outcomes of a control population of adults born full term. Controls will be
sourced from the Generation R study. Generation R is a prospective longitudinal
cohort study that investigates development and health from fetal life until
young adulthood in children born April 2002-January 2006 in Rotterdam, the
Netherlands. Participants of the Generation R study have been invited for
medical examinations, including an eye exam, every 3-4 years.
Study burden and risks
There are no explicit benefits for the participating subjects, aside from
receiving a routine eye exam, which could also be interpreted as a burden.
Subjects make one visit to Erasmus MC for an eye examination. This visit is
expected to take one hour and a half. Travel costs are reimbursed and
participants receive a compensation of 25 euros for their participation.
Routine eye examination does not harm participating subjects and is generally
free of substantial risks. The mydriatic and cylcoplegic eye drops used can
also cause temporary discomfort, with the most common side effects being mild
stinging feeling in the eye, temporary blurred vision, and eye sensitivity to
light. Participants are informed about these and other possible side effects in
the information letter. There could be accidental findings; participants are
informed of accidental findings that are clinically relevant and require
further diagnostics, prevention or treatment. The participation of the
described population is crucial to get a better understanding of the lasting
ophthalmic effects of preterm birth and ROP.
Dr Molewaterplein 40
Rotterdam 3015 GD
NL
Dr Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
1. Subject was born with gestational age < 32 weeks or born with birthweight
<1500 gram or exposed to >40% O2 for > 3 days.
2. Subject was admitted to the NICU at Erasmus MC between 1991 and 2006.
Healthy controls are from the Generation R study.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
1. Subject has passed away before the start of this study
2. Subject resides outside of the Netherlands
3. 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.
For healthy controls, Generation R study subjects that were born preterm (<37
weeks) are excluded.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT06649513 |
| CCMO | NL87522.078.24 |