Simulator Training for Direct Ophthalmoscopy

Direct-Ophthalmoscopy-Simulator-Study

Evaluation of a digital simulator to train diagnostic skills in Ophthalmology

Study Overview

• Status: Completed
• Conditions: Simulator-based Medical Skill Training
• Intervention / Treatment: Device: Simulator-based Training of Direct Ophthalmoscopy

Detailed Description

Direct Ophthalmoscopy is an important tool to detect pathologies e.g. on the optic nerve head. The training of the needed skills is made conventionally in most cases. In such the training sessions students examine each other after dilating one pupil. Examining of patients with pathologies is very important, but in many cases not very easy without any experience.

Simulators are of growing impact to teach diagnostic or surgical skills. A digital simulator with virtual reality technology is used to teach the skills to unexperienced examiners. The head-eye-hand-coordination can be trained without any stress.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Medical student or Ophthalmologist or Neonatologist or Neurologist or Neurosurgeon
• Willing to participate to the study
• Consent to evaluate the measured data

Exclusion Criteria:

• age <18 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Medical Students; Simulator training of 7 patient cases adapted to medical students.	Device: Simulator-based Training of Direct Ophthalmoscopy; A digital simulator is used to teach the skills of direct ophthalmoscopy
Other: Ophthalmologist; Simulator training of 7 patient cases adapted to ophthalmologists.	Device: Simulator-based Training of Direct Ophthalmoscopy; A digital simulator is used to teach the skills of direct ophthalmoscopy
Other: Neurologist/Neurosurgeon/Neonatologist; Simulator training of 7 patient cases adapted to neurologists, neurosurgeons and neonatologists.	Device: Simulator-based Training of Direct Ophthalmoscopy; A digital simulator is used to teach the skills of direct ophthalmoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total examined area	The area that was examined (light on retina) by participants was measured [percent of total area].	1 hour
Efficiency	Ratio of examination time (light in pupil) and total examined area [ratio]	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire	A questionnaire was used to measure the self-evaluation of the trained persons	1 hour
Learning effect	Total examined area results and efficiency ratios were compared between simulator case 1 and simulator case 5.	1 hour

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: November 1, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 8, 2019

Study Record Updates

• Last Update Posted (Actual): November 8, 2019
• Last Update Submitted That Met QC Criteria: November 5, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: simulator; medical skills
• Other Study ID Numbers: Simulator

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: No