Retinopathy of Prematurity (ROP)NCT07312669
ROP Check Database Premature Infant Outcomes
An observational study of Retinopathy of Prematurity (ROP), run by Alaska Blind Child Discovery at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinopathy of Prematurity (ROP)
- How many people
- 7,070 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2010to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: NICU babies eligible for ROP examination
Who may be able to join
- NICU infants
Who cannot join
- Term birth
Trial locations and contacts
1 site in 1 country.
United States1 site
Alaska Children's EYE & Strabismus
Anchorage, Alaska, 99508
About this study
Official title: ROP Check Premature Infant Outcomes
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.
- Conditions
- Retinopathy of Prematurity (ROP)
- Keywords
- gestational age, birthweight, race, gender
- Medical subject headings
- Retinopathy of Prematurity, Birth Weight, Coitus
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2010 through 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start1 Jan 2010
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinopathy of Prematurity (ROP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 7,070 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaska Blind Child Discovery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312669
- Sponsor's protocol ID
- ROPCHECK24
- Status last verified
- Dec 2025
- First submitted
- 23 Nov 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Interest level of other parties
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 at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROP Check Premature Infant Outcomes
- ClinicalTrials.gov ID
- NCT07312669
- Acronym / sponsor ID
- ROPCHECK24
- Conditions
- Retinopathy of Prematurity (ROP)
- Keywords
- gestational age, birthweight, race, gender
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,070 participants (actual)
- Lead sponsor
- Alaska Blind Child DiscoveryUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- NICU babies eligible for ROP examination
Key inclusion criteria (1 listed)
- NICU infants
Key exclusion criteria (1 listed)
- Term birth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ROP treatment: After examination, whether an infant reaching criteria for treatment and what treatment was given. Document the number and the proportion needing treatment.
Time frame: 2010 through 2022
Type 1 ROP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Background: PubMed 28850643Arnold 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.
- Individual participant dataSharing planned: Undecided. Interest level of other parties
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinopathy of Prematurity (ROP), run by Alaska Blind Child Discovery at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ROP treatment: After examination, whether an infant reaching criteria for treatment and what treatment was given. Document the number and the proportion needing treatment. (time frame: 2010 through 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07312669, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.