A Scan Ultrasonography in the Evaluation of Retinopathy o... | NCT01335113

Studies
A Scan Ultrasonography in the Evaluation of Retinopathy of Prematurity

NCT01335113

Sponsor

Stanford University

Status

Terminated

Last Update Posted

Jul 9, 2020Actual

Enrollment

1Actual

Phase

Not provided

Conditions

Retinopathy of Prematurity

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to get accurate measurements with existing technology

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Oct 1, 2015Actual

Completion Date

Oct 1, 2015Actual

First Submitted Date

Apr 1, 2011

First Submission Date that Met QC Criteria

Apr 12, 2011

First Posted Date

Apr 14, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2020

Last Update Posted Date

Jul 9, 2020Actual

Name	Class
University of Miami	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
axial length	axial length as measured by a scan ulstrasonography	one year

Secondary Outcomes

Measure	Description	Time Frame
anterior corneal curvature	anterior corneal curvature as measured by keratometer	one year
wide angle fundus photography	wide angle fundus photography by RetCam camera

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

neonates being screened for retinopathy of prematurity

Exclusion Criteria:

medically unstable neonates

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Premature newborns who are screened for retinopathy of prematurity at Stanford

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Darius M Moshfeghi, MD	Stanford University	Study Director
Darius Moshfeghi, MD	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Miami		Miami	Florida	33136	United States

Condition Browse Module

MeSH Terms

ID	Term
D012178	Retinopathy of Prematurity

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D007235	Infant, Premature, Diseases
D007232	Infant, Newborn, Diseases

Browse Leaves

Not provided

Browse Branches

Not provided