Multicenter Neonatal Eye Disease Screening in China

September 21, 2021 updated by: Peiquan Zhao, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

30000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 days to 1 week (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Otherwise healthy neonates in a multicenter network in China

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
presence of ocular disease
Time Frame: 2 to 7 days after birth
2 to 7 days after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Peiquan Zhao, MD, Xinhua Hospital, School of Medicine, Shanghai Jiaotong University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (ACTUAL)

December 1, 2018

Study Completion (ACTUAL)

December 1, 2018

Study Registration Dates

First Submitted

July 28, 2016

First Submitted That Met QC Criteria

July 28, 2016

First Posted (ESTIMATE)

August 1, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 23, 2021

Last Update Submitted That Met QC Criteria

September 21, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XH-16-019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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