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CompletedNCT07312669Updated Dec 31, 2025

ROP Check Database Premature Infant Outcomes

An observational study in Retinopathy of Prematurity (ROP), sponsored by Alaska Blind Child Discovery. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2025-12-31.

Sponsored by Alaska Blind Child Discovery · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
7,070
Sex
All
01

Study summary

The goal of this observation of multi-centered care of infants covered by ROP Check cloud-based database is to compare demographic and clinical risk factors to evaluate and improve vision-protecting guidelines.

Read the detailed description

Infants from multiple academic and community hospital neonatal intensive care units (NICUs) and their covering ophthalmologists had the serial eye examination and treatment data covered by ROP Check® cloud-based database. ROP Check assists neonatologists to implement guideline scheduling of infants according to the American Academy of Pediatrics (AAP). Outcome included progression to Type 1 retinopathy of prematurity (ROP) and treatment details such as intra-vitreal anti-VEGF injection and peripheral ablative laser. demographic data including birthweight, gestational age, gender, race/ethnicity are analyzed to determine risk factors severe ROP. Blindness-preventing guidelines are reviewed, analyzed and evidence-based updates are proposed.

02

Conditions studied

  • Retinopathy of Prematurity (ROP)

Keywords

  • gestational age, birthweight, race, gender
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

NICU babies eligible for ROP examination

Inclusion criteria

  • NICU infants

Exclusion criteria

Exclusion Criteria:

  • Term birth
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
7,070 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. ROP treatment: After examination, whether an infant reaching criteria for treatment and what treatment was given. Document the number and the proportion needing treatment.

    Type 1 ROP

    Time frame: 2010 through 2022

06

Study locations

1 site
  • Alaska Children's EYE & Strabismus
    Anchorage, Alaska 99508, United States
07

References and documents

Publications

  • Arnold RW, Jacob J, Matrix Z. Toward Achieving 100% Adherence for Retinopathy of Prematurity Screening Guidelines. J Pediatr Ophthalmol Strabismus. 2017 Nov 1;54(6):356-362. doi: 10.3928/01913913-20170329-04. Epub 2017 Aug 29. PubMed 28850643 ↗

Study documents

  • Protocol and statistical analysis plan · Dec 16, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided — Interest level of other parties

08

Registry details

Key details

Study ID
NCT07312669
Lead sponsor
Alaska Blind Child Discovery
Responsible party
Sponsor
First posted
Dec 31, 2025
Start date
Jan 1, 2010
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022
Last update
Dec 31, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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