A Multicenter and Prospective Study of Screening Retinopathy of Prematurity in China (SChiROP)

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Premature Birth of Newborn; Retinopathy of Prematurity (ROP); Low Birthweight Infant

Study type: Observational

Funder types: Other

Identifiers

NCT06729333

XHEC-C-2024-205-1

Details and patient eligibility

About

The purpose of the study is to explore the current incidence rate of retinopathy of prematurity (ROP) in China and to explore more appropriate screening criteria for ROP.

Enrollment: 5,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.