- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03860727
Comparison of Ophthalmoscopy Findings Using PanOptic vs PanOptic + iExaminer
Role of iExaminer as Teaching Aid for Direct Ophthalmoscopy
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14209
- The Ira G. Ross Eye Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
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
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00002262
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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
-
The University of Texas Medical Branch, GalvestonCompleted
-
Lawson Health Research InstituteUnknownLow Vision Aids | Low Vision, One Eye, Unspecified Eye | Low Vision BlindnessCanada
-
University of Alabama at BirminghamRecruitingLow Vision, Both EyesUnited States
-
University of California, Los AngelesUniversity of Nebraska; Southern California College of Optometry at Marshall... and other collaboratorsRecruitingLow Vision | Low Vision AidsUnited States
-
Aristotle University Of ThessalonikiRecruitingLow Vision Digital AssistanceGreece
-
Sun Yat-sen University2nd Affilliated Hospital of Fujian Medical UniversityRecruitingArtificial Intelligence | Ophthalmology | Low Vision AidsChina
-
Pamukkale UniversityCompleted
-
Vortant Technologies, LLCSuspendedBlindness and Low VisionUnited States
-
Sun Yat-sen UniversityRecruitingArtificial Intelligence | Ophthalmology | Low Vision AidsChina
-
Democritus University of ThraceCompletedPresbyopia | Low Vision | Near VisionGreece
Clinical Trials on Welch Allyn IExaminer
-
ARC DevicesWithdrawn
-
Children's Hospital ColoradoWelch AllynUnknown
-
Lady Davis InstituteCarebook Technologies Inc.UnknownVascular Diseases | Coronavirus | Respiratory Disease | Cardiac Disease
-
Infrared Cameras IncorporateCompleted
-
Massachusetts General HospitalVital USA, Inc.CompletedMultimorbidityUnited States
-
NCH Heatlhcare System IncWelch AllynUnknownHeart FailureUnited States
-
Istanbul UniversityCompletedFailed or Difficult IntubationTurkey
-
Xim LimitedUniversity of PortsmouthCompletedVital SignsUnited Kingdom
-
Cambridge University Hospitals NHS Foundation TrustObstetric Anaesthetists' AssociationRecruitingAnesthesiaUnited Kingdom