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CompletedNCT02851251Updated Sep 23, 2021

Multicenter Neonatal Eye Disease Screening in China

An observational study in Eye Disease, sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Completed at 1 site in China. Open to participants aged 2 Days to 7 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-23.

Sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30,000
Ages
2 Days to 7 Days
Sex
All
01

Study summary

These exams are vital to protect healthy neonates from blindness. The purpose of this study is to better screen ocular disease in otherwise healthy neonates using wide-field digital imaging system (RetCam III) in a multi-center network in China leaded by Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine. The multi-center network will be built with the collaboration of eight hospitals from different parts of China.

Read the detailed description

Studies reveal that ocular anomalies may also be found in healthy full-term babies. These abnormal ocular findings included subconjunctival haemorrhage, congenital microphthalmos, congenital corneal leukoma, posterior synechia, persistent pupillary membrane, congenital cataract, enlarged C/D ratio, retinal hamartoma versus retinoblastoma, optic nerve defects, macular pigment disorder and non-specific peripheral retinopathy. The highest proportion of these abnormal findings is retinal haemorrhages, accounting for 92% of abnormalities. Most retinal hemorrhages are benign and will finally self-resolve. However, sometimes it takes a long time for the hemorrhage to resolve. Some slow-resolving hemorrhages could obstruct the visual axis and may do great harm to visual development in critical period. Some neonatal eye diseases are time sensitive, such as retinoblastoma, and if found late, the best opportunity for effective treatment is missed, leading to irreversible visual impairment. Newborns are unable to express their discomforts or visual disorders as adults do and only through an examination, the neonatal eye diseases can be detected. Therefore, this screening protocol is designed to screen the otherwise healthy neonates in a multi-center network on neonatal ophthalmopathy and to achieve early diagnosis and timely treatment. All the neonates will undergo eye examination by using RetCam III. The external eye, pupillary light reflex, red reflex, opacity of refractive media, anterior chamber and posterior segments will be examined. The outcomes will be analyzed by a blinded specialist in order to discover serious congenital, hereditary and acquired diseases in the neonatal period of healthy newborns and to improve epidemiological information of neonatal ophthalmopathy. Neonatal ocular examination may play a positive role in promoting paediatric eye health to paediatricians and parents.

02

Conditions studied

  • Eye Disease

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Keywords

  • eye disease
  • neonatal eye disease
  • newborn
  • screening
  • multicenter
03

In context

Eye Diseases

740 studies on the registry are indexed under Eye Diseases; 117 are open to participants now.

This study's enrollment of 30,000 is above the median of 120 across 172 observational studies indexed under Eye Diseases.

Browse Eye Diseases studies →

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 222 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Days to 7 Days
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Otherwise healthy neonates in a multicenter network in China

Inclusion criteria

  • Otherwise healthy neonates ( ≥37weeks' gestational age, weighing ≥2500 g, no evidence of systemic disease and an Apgar score of 7 or more.)

Exclusion criteria

Exclusion Criteria:

  • Preterm /Neonates with systemic diseases
  • Neonates unable to undergo the examination
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30,000 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. presence of ocular disease

    Time frame: 2 to 7 days after birth

07

Study locations

1 site
  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
    Shanghai, 200092, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02851251
Lead sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Responsible party
Peiquan Zhao (Professor, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Aug 1, 2016
Start date
Jul 2016
Primary completion
Dec 2018
Completion
Dec 2018
Last update
Sep 23, 2021

Study contacts

Peiquan Zhao, MD
principal investigator · Xinhua Hospital, School of Medicine, Shanghai Jiaotong University, China

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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