NCT07031960

Brief Summary

The goal of this clinical trial is to evaluate whether a new 3D-printed eyeball movement simulator improves medical education compared to traditional teaching methods. The main questions it aims to answer are: Does using the 3D simulator help medical students better understand eye anatomy and muscle function compared to standard lectures and textbooks? How do students rate the usability and effectiveness of this new teaching tool? Researchers will compare two groups of medical students: One group will learn using the 3D simulator The other group will receive standard teaching methods Participants will:

  1. 1.Complete a pre-test to assess their baseline knowledge
  2. 2.Attend training sessions using either the 3D simulator or standard methods
  3. 3.Take a post-test to measure learning improvement
  4. 4.Provide feedback about their learning experience
  5. 5.Take a post-intervention exam and satisfaction survey
  6. 6.Participate in focus groups about their learning experience

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

June 15, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 22, 2025

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2025

Completed
Last Updated

June 22, 2025

Status Verified

June 1, 2025

Enrollment Period

15 days

First QC Date

June 9, 2025

Last Update Submit

June 19, 2025

Conditions

Keywords

medical education3D modeleye movement

Outcome Measures

Primary Outcomes (1)

  • Knowledge Gain Score

    Difference in test scores between pre-intervention and post-intervention assessments on eye anatomy and movement kinematics, measured using a validated 50-point multiple-choice questionnaire

    Baseline (pre-intervention), Immediately after intervention (1 day post-training)

Secondary Outcomes (2)

  • Skill Acquisition in Eye Movement Assessment

    "Baseline" or "Day 1"

  • Student Satisfaction Scores

    Immediately post-intervention

Study Arms (2)

3D Eyeball Movement Simulator Group

EXPERIMENTAL

Arm 1 (Experimental Group): Participants in this arm will use an interactive 3D-printed simulator that physically replicates human eyeball movements and extraocular muscle function. This hands-on educational tool allows medical students to manipulate the model and observe biomechanical principles of eye movements in real-time.

Device: 3D Eyeball Movement Simulator Group

Conventional Teaching Methods Group

ACTIVE COMPARATOR

Participants in this arm will receive standard anatomy instruction through traditional methods including didactic lectures, 2D textbook illustrations, and static anatomical models - representing the current typical curriculum for ophthalmic anatomy education.

Other: Conventional Teaching Methods Group

Interventions

A physical, interactive 3D-printed educational model that replicates human eyeball movements and demonstrates the biomechanical action of extraocular muscles. The simulator allows hands-on manipulation to demonstrate all cardinal eye movements (adduction, abduction, elevation, depression, intorsion, and extorsion) through mechanical actuation of synthetic muscle analogues."

3D Eyeball Movement Simulator Group

Standard medical education methods for teaching eye anatomy and movements, including: (1) didactic classroom lectures with 2D illustrations, (2) static anatomical models of the orbit and eyeball, and (3) textbook-based learning materials. This represents the current conventional approach to teaching this content in medical curricula

Conventional Teaching Methods Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Academic Status Currently enrolled medical students in their preclinical years (typically 2nd-3 year)"
  • Course Enrollment "Formally registered in the special scence/anatomy course where eye movement education is part of the curriculum"
  • Prior Experience "No previous formal training in extraocular muscle anatomy or eye movement assessment"
  • Language Proficiency "Fluent in the language of instruction (Farsi)"
  • Consent "Willing and able to provide informed consent"

You may not qualify if:

  • Prior Exposure "Medical students who have previously taken advanced special scence courses"
  • Professional Experience "Students with prior clinical experience in ophthalmology ( as nurses or technicians)"
  • Atypical Curriculum "Students from schools with non-standard anatomy curricula that already include similar 3D simulation tools"
  • Participation Conflicts "Currently participating in other educational research studies that could confound results"

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Mehrnoush Malekzadeh, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 9, 2025

First Posted

June 22, 2025

Study Start

June 15, 2025

Primary Completion

June 30, 2025

Study Completion

August 20, 2025

Last Updated

June 22, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share