Long-term Ophthalmic Outcomes in Ex-premature Infants
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorErasmus Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects eligible for ROP screening, and admitted to Erasmus MC between 1991 and 2007.
Disqualifiers
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.
Trial population
Premature patients who were eligible for ROP screening, who were admitted to Erasmus MC between 1991 and 2007.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
eye drops (Tropicamid)
Diagnostic testMydriatic + cycloplegic eye drops are given to measure refractive error and to image the full retina.
Treatment groups
210 Participants
are divided into 1 treatment groupGroup A: Preterm patients1 intervention
Trial outcomes
Primary outcomes
1
Visual acuity
Measured with ETDRS chart. Expressed in Logarithm of the Minimum Angle of Resolution (LogMAR)
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.Secondary outcomes
1
Biometric, refractive, fundus and Optical coherence tomography (OCT) data.
* Refraction (spherical equivalent) in dioptre (D) measured with an automatic refractometer. * Optical biometry measurements (axial eye length in millimeters, lens thickness in millimeters, anterior chamber depth in millimeters) measured with an optical biometer. * Intra-ocular pressure (IOP) in millimeter in mercury (mmHg) measured with a non-contact or contact tonometer. * Visual field abnormalities measured with a Humphrey Field Analyzer (HFA), expressed as Visual Field Index (VFI), Mean Deviation (MD) and Pattern Standard Deviation (PSD) in decibels (dB). * Macula thickness in micrometers (µm) measured on Optical coherence tomography (OCT) images. * Any anatomical abnormalities of the retina and choroid seen on OCT of fundus images. * Presence of ophthalmological diagnoses such as amblyopia or strabismus. * Relevant (ophthalmological) medical history/ophthalmological diagnosis in the past. * Self-reported health, educational level, screen time and activity level (questionnaire).
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: