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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06729333

Acronym

SChiROP

Enrollment

4841

Registered

2024-12-11

Start date

2024-12-03

Completion date

2026-05-17

Last updated

2026-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Birthweight Infant, Premature Birth of Newborn, Retinopathy of Prematurity (ROP)

Keywords

retinopathy of prematurity, incidence rate, screening

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

Measure	Time frame
The incidence rate of ROP	6 months after the first screening
Gestational age at which treatment-requiring ROP develops	6 months after the first screening
Birthweight at which treatment-requiring ROP develops	6 months after the first screening

Secondary

Measure	Time frame
Gestational age of infants developing any ROP lesion	6 months after the first screening
Birthweight of infants developing any ROP lesion	6 months after the first screening
Postmenstrual age (PMA) at which ROP lesions occur	6 months after the first screening
PMA at which treatment-requiring ROP occurs	6 months after the first screening
Screening and treatment costs	6 months after the first screening

Countries

China

Outcome results