NCT01335113

Brief Summary

The purpose of the investigators study is to determine the relationship between the length of the eye and the rate of change in eye length at each visit with progression of retinopathy of prematurity.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 14, 2011

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

5 years

First QC Date

April 1, 2011

Last Update Submit

July 7, 2020

Conditions

Retinopathy of Prematurity

Outcome Measures

Primary Outcomes (1)

  • axial length

    axial length as measured by a scan ulstrasonography

    one year

Secondary Outcomes (2)

  • anterior corneal curvature

    one year

  • wide angle fundus photography

    one year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Premature newborns who are screened for retinopathy of prematurity at Stanford

You may qualify if:

  • neonates being screened for retinopathy of prematurity

You may not qualify if:

  • medically unstable neonates

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Retinopathy of Prematurity

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Darius M Moshfeghi, MD

    Stanford University

    STUDY DIRECTOR

  • Darius Moshfeghi, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

April 1, 2011

First Posted

April 14, 2011

Study Start

October 1, 2010

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

July 9, 2020

Record last verified: 2020-07

Locations

US(1)