NCT04959422

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

July 2, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 13, 2021

Completed
2.1 years until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

July 14, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

July 2, 2021

Last Update Submit

July 13, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of children who complete vision evaluation

    Number of children who complete vision evaluation with vision specialist

    Approximately 1 year

Secondary Outcomes (1)

  • Number of children with amblyopia or pre amblyopic strabismus identified and treated

    Approximately 1 year

Study Arms (1)

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

Active scheduling, tracking and rescheduling, if necessary.

Active scheduling

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Darmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Andrew J Schuman

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Physician, Pediatrics

Study Record Dates

First Submitted

July 2, 2021

First Posted

July 13, 2021

Study Start

September 1, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

July 14, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

There are no plan to share IPD at this time.

Locations