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
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.
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.
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 →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.
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Otherwise healthy neonates in a multicenter network in China
Exclusion Criteria:
presence of ocular disease
Time frame: 2 to 7 days after birth
Plan to share: Undecided
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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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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine