Vision ScreeningNCT04959422
Assuring Ophthalmologic Follow up
A study testing Active scheduling in people with Vision Screening and Amblyopia, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Vision Screening, Amblyopia
- What is being tested?
- Active scheduling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to Dec 2023
- Phase
- Interventional
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Darmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: Assuring Ophthalmologic Follow up for Children Referred Following Instrument-based Vision Screening in a Pediatric Clinic: Effect of Immediate Referral Scheduling and Tracking
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.
Read the 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.
- Conditions
- Vision Screening, Amblyopia
- Being tested
- Active scheduling
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active schedulingOther
Active scheduling, tracking and rescheduling, if necessary.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Active scheduling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of children who complete vision evaluation
Number of children who complete vision evaluation with vision specialist
Measured: Approximately 1 year
Secondary outcomes (1)
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.
Measured: Approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start1 Sep 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: No participants were enrolled in the study, and staff has been reduced and cannot support the trial any longer.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vision ScreeningStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew J. Schuman, Dartmouth-Hitchcock Medical Center
- Investigators
- Andrew J Schuman, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959422
- Sponsor's protocol ID
- STUDY02000101
- Status last verified
- Jul 2023
- First submitted
- 2 Jul 2021
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plan to share IPD at this time.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assuring Ophthalmologic Follow up for Children Referred Following Instrument-based Vision Screening in a Pediatric Clinic: Effect of Immediate Referral Scheduling and Tracking
- ClinicalTrials.gov ID
- NCT04959422
- Acronym / sponsor ID
- STUDY02000101
- Conditions
- Vision Screening, Amblyopia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants were enrolled in the study, and staff has been reduced and cannot support the trial any longer.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 13 Jul 2021 (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 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active scheduling | Experimental | Other: Active schedulingChildren 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. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active schedulingActive scheduling, tracking and rescheduling, if necessary. | Other | Active scheduling |
Primary outcome
Number of children who complete vision evaluation
Time frame: Approximately 1 year
Number of children who complete vision evaluation with vision specialist
1 secondary outcome
Number of children with amblyopia or pre amblyopic strabismus identified and treated
Time frame: Approximately 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Individual participant dataSharing planned: No. There are no plan to share IPD at this time.
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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.
Andrew J Schuman principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active scheduling in people with Vision Screening and Amblyopia, run by Dartmouth-Hitchcock Medical Center 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 3 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: withdrawn, as of the sponsor's last update on 14 Jul 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
Number of children who complete vision evaluation (time frame: Approximately 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2023.