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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Death before the first screening;

Death or loss to follow-up before complete retinal vascularization;

Presence of other diseases causing incomplete retinal vascularization, such as familial exudative vitreoretinopathy, incontinentia pigmenti, or Coats disease;

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;

Trial population

Tertiary hospital

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

The incidence rate of ROP

Time frame
6 months after the first screening
2

Gestational age at which treatment-requiring ROP develops

Time frame
6 months after the first screening
3

Birthweight at which treatment-requiring ROP develops

Time frame
6 months after the first screening

Secondary outcomes

1

Gestational age of infants developing any ROP lesion

Time frame
6 months after the first screening
2

Birthweight of infants developing any ROP lesion

Time frame
6 months after the first screening
3

Postmenstrual age (PMA) at which ROP lesions occur

Time frame
6 months after the first screening
4

PMA at which treatment-requiring ROP occurs

Time frame
6 months after the first screening

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: