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

NCT ID: NCT03347799

Last Updated: 2023-02-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 570 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-07-01
• Study Completion Date: 2017-09-01

Brief 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

Retinopathy of Prematurity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• All infants born below 32 weeks gestation within the study period
• At least one eye examination recorded by Retcam

Exclusion Criteria

• Any ophthalmic abnormality
• Any genetic abnormality

• Minimum Eligible Age: 24 Weeks
• Maximum Eligible Age: 40 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Jean-Michel HASCOET

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

PSS2016/WINROP-HASCOET/VS

Identifier Type: -

Identifier Source: org_study_id