Long-term Ophthalmic Outcomes in Ex-premature Infants

NCT06649513 | Not Yet Recruiting

• 1 other identifier: 12793
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinopathy of Prematurity (ROP); Premature Birth

Keywords

Retinopathy of Prematurity; Preterm birth; Visual acuity; Visual outcomes; Long term outcomes

Outcome Measures

Primary Outcomes (1)

• Visual acuity

  Measured with ETDRS chart. Expressed in Logarithm of the Minimum Angle of Resolution (LogMAR)

  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.

  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.

Study Arms (1)

Preterm patients

Former patients who were born prematurely (GA \< 37 weeks)

Diagnostic Test: eye drops (Tropicamid)

Interventions

eye drops (Tropicamid) DIAGNOSTIC_TEST

Mydriatic + cycloplegic eye drops are given to measure refractive error and to image the full retina.

Preterm patients

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3015 GD, Netherlands

Location

MeSH Terms

Conditions

Retinopathy of Prematurity; Premature Birth

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Angela Arends-Tjiam, Dr

CONTACT

+31653616960; a.arends-tjiam@erasmusmc.nl

Lizanne Derks, BSc

CONTACT

+31653901136; l.derks@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Ophthalmologist

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: October 18, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2030
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)