Comparison of Ophthalmoscopy Findings Using PanOptic vs PanOptic + iExaminer

NCT03860727 | Completed FDA Device

• 1 other identifier: STUDY00002262
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To examine how helpful the iExaminer will be as a training aid for medical students. The investigators will look into whether 1) it helps the medical students find pertinent eye findings for certain diagnoses and 2) it improves the medical students comfort level compared to using the PanOptic alone.

Conditions

Vision Disorders

Outcome Measures

Primary Outcomes (1)

• Students confidence in using iExaminer to diagnose fundus findings

  Students will be provided with survey questions to assess their confidence level in accurately diagnosing fundus findings using iExaminer combined with Panoptic vs Panoptic alone

  9 months

Secondary Outcomes (1)

• Students comfort in using iExaminer combined with Panoptic vs Panoptic alone

  9 months

Interventions

Welch Allyn IExaminer DIAGNOSTIC_TEST

Fundus Examination

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Second-year medical students at the University at Buffalo Jacobs School of Medicine and Biomedical Sciences attending Ophthalmoscopy class as a part of required didactic sessions. Volunteering patients with normal or eye pathology will be recruited for students to perform Ophthalmoscopy with PanOptic and iExaminer

You may qualify if:

• \- All second-year medical students at the University at Buffalo Jacobs School of Medicine and Biomedical Sciences may be included in our final study sample.

You may not qualify if:

• Students who have had significant prior exposure to direct ophthalmoscopy (e.g. they have used the direct ophthalmoscopy, PanOptic, or PanOptic with the iExaminer on a regular basis for more than one week).
• Students with poor enough visual acuity that will prevent them from doing direct ophthalmoscopy

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• Welch Allyn: collaborator

Study Sites (1)

The Ira G. Ross Eye Institute

Buffalo, New York, 14209, United States

Location

MeSH Terms

Conditions

Vision Disorders

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Reynolds, MD

  The Ira G. Ross Eye Institute - University at Buffalo

  PRINCIPAL INVESTIGATOR

• Pimpiroon Ploysangam

  The Ira G. Ross Eye Institute - University at Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: March 4, 2019
• Study Start: August 28, 2018
• Primary Completion: May 7, 2019
• Study Completion: May 7, 2019
• Last Updated: October 20, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)