Comparison of Ophthalmoscopy Findings Using PanOptic vs PanOptic + iExaminer

October 19, 2020 updated by: Andrew L Reynold, State University of New York at Buffalo

Role of iExaminer as Teaching Aid for Direct Ophthalmoscopy

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Direct ophthalmoscopy is a vital skill for screening emergent conditions as well as chronic ocular pathologies for nonophthalmic physicians. Many eye care practitioners are first exposed to this tool during their medical education and are expected to have a certain degree of proficiency with it down the line. This skill requires practice, however, and given that there is a limited amount of time and exposure, it is not surprising that there is a general lack of familiarity and confidence among students and physicians with using the direct ophthalmoscope (Gilmour et al.,2017; Schulz et al., 2014; Day et al.,2017).

A myriad of techniques and models have attempted to change this and improve the efficacy in teaching direct ophthalmoscopy. Studies have shown that students prefer learning how to use the direct ophthalmoscope with human subjects rather than simulators, and that the students prefer using fundus photographs to learn important diagnostic findings over the ophthalmoscope (Kelly et al.,2013). There have also been studies comparing the direct ophthalmoscope to the PanOptic, which gives a fixed working distance from the patient and a larger field of view (Day et al.,2017). These studies have noted more "ease of use" and accuracy in using the PanOptic among first year medical students and physicians (McComiskie et al.,2004; Petrushkin et al., 2012). New technological advances such as the iExaminer application have also been recently introduced, allowing the eye care physicians to take fundus images on their smart phone using a smart phone application and attachment to the PanOptic. Studies have shown the iExaminer application is able to produce "clinically adequate" fundus images (Day et al.,2017).

From the literature review, there have not been any studies that compare the PanOptic alone versus the PanOptic with the iExaminer application as an introductory teaching tool for medical students. The iExaminer will not only allow the user to utilize the view obtained from the PanOptic, but also allow an instructor to observe and help coach the user on relevant findings and take pictures for future reference or instruction. This provides a potentially effective learning device which can help users accurately identify more relevant ophthalmic findings. The investigators also believe that this will help increase the medical students confidence level and encourage them to practice with these devices again at future opportunities.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • Buffalo, New York, United States, 14209
        • The Ira G. Ross Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

- 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Students confidence in using iExaminer to diagnose fundus findings
Time Frame: 9 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Students comfort in using iExaminer combined with Panoptic vs Panoptic alone
Time Frame: 9 months
The fundus findings diagnosed by students using panoptic with be compared to when students used iExaminer attached to Panoptic
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2018

Primary Completion (Actual)

May 7, 2019

Study Completion (Actual)

May 7, 2019

Study Registration Dates

First Submitted

September 13, 2018

First Submitted That Met QC Criteria

February 28, 2019

First Posted (Actual)

March 4, 2019

Study Record Updates

Last Update Posted (Actual)

October 20, 2020

Last Update Submitted That Met QC Criteria

October 19, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00002262

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vision Disorders

Clinical Trials on Welch Allyn IExaminer

3
Subscribe