A Multicenter and Prospective Study of Screening Retinopathy of Prematurity in China

Launched by XINHUA HOSPITAL, SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE · Dec 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying retinopathy of prematurity (ROP), a condition that can affect premature babies and those with low birth weight. The goal is to find out how common ROP is in China and to develop better guidelines for screening these infants. The trial will take place at Xinhua Hospital and other partner locations between December 2024 and May 2025.

To participate, infants must be born before 37 weeks of pregnancy or weigh less than 2,500 grams at birth. However, some babies won't be eligible, such as those who have passed away before their first eye exam or have other serious eye conditions. Families can expect their babies to receive regular eye screenings to check for ROP, which is important for preventing vision problems later on. This research aims to improve how we identify and treat ROP in the future, ultimately helping more babies see clearly as they grow.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • From December 2024 to May 2025, preterm infants (gestational age \<37 weeks) or low birth weight infants (birth weight \<2500 g) who receive their first ROP screening at Xinhua Hospital or partner institutions will be included.
• Exclusion Criteria:
• • 1. Death before the first screening;
• • 2. Death or loss to follow-up before complete retinal vascularization;
• • 3. Presence of other diseases causing incomplete retinal vascularization, such as familial exudative vitreoretinopathy, incontinentia pigmenti, or Coats disease;
• • 4. Coexisting conditions affecting the classification or staging of ROP, such as corneal opacity, congenital cataract, persistent fetal vasculature, retinoblastoma, anophthalmia, Terson syndrome, or other ocular infections or diseases;
• • 5. Poor systemic condition preventing fundus examination;
• • 6. History of ocular trauma or surgery (excluding treatments for ROP);
• • 7. Poor-quality fundus images;
• • 8. Other conditions deemed exclusionary by the investigators.