Assuring Ophthalmologic Follow up | NCT04959422

Studies
Assuring Ophthalmologic Follow up

NCT04959422

Sponsor

Dartmouth-Hitchcock Medical Center

Status

Withdrawn

Last Update Posted

Jul 14, 2023Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Vision Screening
Amblyopia

Interventions

Active scheduling

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 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No participants were enrolled in the study, and staff has been reduced and cannot support the trial any longer.

Expanded Access Info

Start Date

Sep 1, 2023Estimated

Primary Completion Date

Dec 1, 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Jul 2, 2021

First Submission Date that Met QC Criteria

Jul 2, 2021

First Posted Date

Jul 13, 2021Actual

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 13, 2023

Last Update Posted Date

Jul 14, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andrew J. Schuman, Principal Investigator, Physician, Pediatrics, Dartmouth-Hitchcock Medical CenterPrincipal Investigator

Lead Sponsor

Dartmouth-Hitchcock Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 goal of this study is to quantify the improvement in completed ophthalmology referrals and quantify the number of children identified and treated for amblyopia or pre amblyopic strabismus resulting from the implementation of a new referral and tracking system.

Detailed Description

Children who fail instrument vision screens at Dartmouth Hitchcock (D-H) Community Group Practice (CGP) Pediatric Clinics will be scheduled at a community vision specialist office before departure from the Pediatric clinic. If the patient does not attend the appointment (a no show) at the vision specialist office , this will be tracked and the patient will be rescheduled.

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active scheduling	Experimental	Children who fail instrument vision screens will be scheduled at a community vision specialist office before departure from clinic and all no shows at the vision specialist office will be tracked and rescheduled.	Other: Active scheduling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Active scheduling	Other	Active scheduling, tracking and rescheduling, if necessary.	Active scheduling

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of children who complete vision evaluation	Number of children who complete vision evaluation with vision specialist	Approximately 1 year

Secondary Outcomes

Measure	Description	Time Frame
Number of children with amblyopia or pre amblyopic strabismus identified and treated	Number of children with amblyopia or pre amblyopic strabismus identified and treated with a vision specialist.	Approximately 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All pediatrics patients without pre-existing vision problems undergoing instrument vision screening at DH Pediatric CGP Clinics in at ages 2,3,4,5, and 6 years of age.

Exclusion Criteria:

All pediatric patients with pre-existing eye problems that would cause them to be excluded from the study.
All patients of parents who choose to go to an eyecare provider other than the one participating in the study (as we would be unable to make appointments or track appointments).
All patients of parents who refuse to make an appointment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrew J Schuman	Dartmouth-Hitchcock Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Darmouth-Hitchcock Medical Center		Lebanon	New Hampshire	03756	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

There are no plan to share IPD at this time.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000550	Amblyopia

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014786	Vision Disorders

Browse Leaves

Not provided

Browse Branches

Not provided