Vision DisordersNCT03860727
Comparison of Ophthalmoscopy Findings Using PanOptic vs PanOptic + iExaminer
An observational study of Vision Disorders, run by State University of New York at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Vision Disorders
- What is being tested?
- Welch Allyn IExaminer
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2018to 7 May 2019
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ira G. Ross Eye Institute
Buffalo, New York, 14209
About this study
Official title: 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.
Read the 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.
- Conditions
- Vision Disorders
- Being tested
- Welch Allyn IExaminer
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Welch Allyn IExaminerDiagnostic test
Fundus Examination
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 9 months
Secondary outcomes (1)
Students comfort in using iExaminer combined with Panoptic vs Panoptic alone
The fundus findings diagnosed by students using panoptic with be compared to when students used iExaminer attached to Panoptic
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start28 Aug 2018
- Primary completion7 May 2019
- Study completion7 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vision DisordersStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Welch Allyn
- Responsible party
- Principal investigator, Andrew L Reynold, State University of New York at Buffalo
- Investigators
- Andrew Reynolds, MD, Principal investigator, The Ira G. Ross Eye Institute - University at BuffaloPimpiroon Ploysangam, Principal investigator, The Ira G. Ross Eye Institute - University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860727
- Sponsor's protocol ID
- STUDY00002262
- Status last verified
- Oct 2020
- First submitted
- 13 Sep 2018
- Last updated
- 20 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of iExaminer as Teaching Aid for Direct Ophthalmoscopy
- ClinicalTrials.gov ID
- NCT03860727
- Acronym / sponsor ID
- STUDY00002262
- Conditions
- Vision Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- Welch Allyn
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 7 May 2019 (actual)
- Study completion
- 7 May 2019 (actual)
- First posted
- 4 Mar 2019 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Welch Allyn IExaminerFundus Examination | Diagnostic test | – |
Primary outcome
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
1 secondary outcome
Students comfort in using iExaminer combined with Panoptic vs Panoptic alone
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Individual participant dataSharing planned: No
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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 Reynolds, MD principal investigator
The Ira G. Ross Eye Institute - University at Buffalo
Pimpiroon Ploysangam principal investigator
The Ira G. Ross Eye Institute - University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vision Disorders, run by State University of New York at Buffalo 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 2 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: finished, as of the sponsor's last update on 20 Oct 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Students confidence in using iExaminer to diagnose fundus findings (time frame: 9 months). 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 20 Oct 2020.