Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02851251 |
Other study ID # |
XH-16-019 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
July 2016 |
Est. completion date |
December 2018 |
Study information
Verified date |
September 2021 |
Source |
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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.