NCT06693804

Brief Summary

The purpose of the study is to evaluate the effectiveness of Welch Allyn PanOptic Plus Ophthalmoscope with smartphone adaptor, and assess residents' opinions on acceptability and usability of the device and curriculum vs the conventional non-digital device used in current clinical practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 18, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

February 5, 2025

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

July 17, 2025

Status Verified

July 1, 2025

Enrollment Period

24 days

First QC Date

November 10, 2024

Last Update Submit

July 15, 2025

Conditions

Keywords

otoscopeophthalmoscopevisual artsresidentdeviceinstrumenteye examear examfamily medicineeducation

Outcome Measures

Primary Outcomes (4)

  • Resident Confidence Survey (Pre)

    Survey will measure Resident's confidence. Survey will consist of 10 questions based on a Likert scale where a value of 1=not at all confident and 5=very confident. A score of 10 would indicate no confidence and a score of 50 would indicate complete confidence.

    0 months

  • Resident Knowledge Survey (Post)

    Survey will measure Resident's knowledge. Survey will consist of 12 questions based on a Likert scale where a value of 1=not at all confident and 5=very confident. A score of 12 would indicate absence of knowledge and a score of 60 would indicate complete knowledge.

    3 months

  • Visual Identification of Images (Pre)

    Residents will be shown 34 images of the eye and ear which they will need to correctly identify. Correct identification of 0 images = lowest score. Correct identification of 34 images = highest score.

    0 months

  • Visual Identification of Images (Post)

    Residents will be shown 34 images of the eye and ear which they will need to correctly identify. Correct identification of 0 images = lowest score. Correct identification of 34 images = highest score.

    3 months

Study Arms (2)

Welch Allyn PanOptic iExaminer Digital Imaging Kit

EXPERIMENTAL

Novel digital instrument to visualize eyes and ears in clinical practice

Other: Digital Otoscope and Ophthalmoscope

Conventional non-digital instrument used in current clinical training and standard practice

ACTIVE COMPARATOR

Standard practice

Other: Conventional otoscope and ophthalmoscope

Interventions

The otoscope and ophthalmoscope will be used by residents to examine the eyes and ears under illumination and magnification during physical examinations.

Welch Allyn PanOptic iExaminer Digital Imaging Kit

The otoscope and ophthalmoscope will be used by residents to examine the eyes and ears under illumination during physical examinations.

Conventional non-digital instrument used in current clinical training and standard practice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Resident in Penn States Family and Community Medicine Department

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Penn State Milton S. Hershey Medical Center

Harrisburg, Pennsylvania, 17112, United States

Location

Penn State Health St. Joseph Medical Center

Reading, Pennsylvania, 19605, United States

Location

MeSH Terms

Interventions

Ophthalmoscopes

Intervention Hierarchy (Ancestors)

Diagnostic EquipmentEquipment and Supplies

Study Officials

  • Joseph Wiedemer, MD

    The Pennsylvania State University, College of Medicine, Family and Community Medicine Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Associate Professor, Program Director of Penn State Health Family and Community Medicine Residency at Mount Nittany Medical Center

Study Record Dates

First Submitted

November 10, 2024

First Posted

November 18, 2024

Study Start

February 5, 2025

Primary Completion

March 1, 2025

Study Completion

June 1, 2025

Last Updated

July 17, 2025

Record last verified: 2025-07

Locations