Clinical Trials Directory

Trials / Completed

CompletedNCT03347799

WINROP Algorithm Validation for Retinopathy Screening in a Cohort of Premature Infants

WINROP Algorithm Validation for Retinopathy Screening in Premature Infants: a Retrospective Cohort Analysis Over 4 Years

Status
Completed
Phase
Study type
Observational
Enrollment
570 (actual)
Sponsor
Central Hospital, Nancy, France · Academic / Other
Sex
All
Age
24 Weeks – 40 Weeks
Healthy volunteers
Not accepted

Summary

When a child was born too early, it is more likely to develop an alteration of its visual function than in the case of term birth. Significant visual disturbances are found in 3% of children born prematurely, but visual impairment can be very severe, up to the loss of vision in case of retinopathy of prematurity (ROP) in the most immature infants. The introduction of screening surveillance systems, such as WINROP software, might reduce the need for stressful eye examination in low risk neonates. This retrospective study aimed at validating the WINROP algorithm in a cohort of premature infants, born below 32 weeks of gestation, who had systematic eye examination for ROP screening over 4 year period.

Conditions

Timeline

Start date
2012-07-01
Primary completion
2016-07-01
Completion
2017-09-01
First posted
2017-11-20
Last updated
2023-02-15

Source: ClinicalTrials.gov record NCT03347799. Inclusion in this directory is not an endorsement.