Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 5:49 AM
Study NCT ID:
NCT07031960
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-22
First Post:
2025-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
3D Eye Movement Simulator for Medical Education
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-08-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-19', 'studyFirstSubmitDate': '2025-06-09', 'studyFirstSubmitQcDate': '2025-06-19', 'lastUpdatePostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knowledge Gain Score', 'timeFrame': 'Baseline (pre-intervention), Immediately after intervention (1 day post-training)', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Skill Acquisition in Eye Movement Assessment', 'timeFrame': '"Baseline" or "Day 1"', 'description': 'Performance in practical examination where students identify and demonstrate eye movements on standardized patients, scored by blinded evaluators using a 12-point checklist.'}, {'measure': 'Student Satisfaction Scores', 'timeFrame': 'Immediately post-intervention', 'description': 'Participant-reported satisfaction with the teaching method measured via 5-point Likert scale survey (1=very dissatisfied to 5=very satisfied).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['medical education', '3D model', 'eye movement'], 'conditions': ['Education', 'Education, Medical, Undergraduate', 'Education, Medical']}, 'descriptionModule': {'briefSummary': '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:\n\nDoes using the 3D simulator help medical students better understand eye anatomy and muscle function compared to standard lectures and textbooks?\n\nHow do students rate the usability and effectiveness of this new teaching tool?\n\nResearchers will compare two groups of medical students:\n\nOne group will learn using the 3D simulator\n\nThe other group will receive standard teaching methods\n\nParticipants will:\n\n1. Complete a pre-test to assess their baseline knowledge\n2. Attend training sessions using either the 3D simulator or standard methods\n3. Take a post-test to measure learning improvement\n4. Provide feedback about their learning experience\n5. Take a post-intervention exam and satisfaction survey\n6. Participate in focus groups about their learning experience\n\nThe study will help determine if interactive 3D models can enhance medical education about eye movements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Academic Status Currently enrolled medical students in their preclinical years (typically 2nd-3 year)"\n2. Course Enrollment "Formally registered in the special scence/anatomy course where eye movement education is part of the curriculum"\n\nPrior Experience "No previous formal training in extraocular muscle anatomy or eye movement assessment"\n\nLanguage Proficiency "Fluent in the language of instruction (Farsi)"\n\nConsent "Willing and able to provide informed consent"\n\nExclusion Criteria:\n\n1- Prior Exposure "Medical students who have previously taken advanced special scence courses"\n\nProfessional Experience "Students with prior clinical experience in ophthalmology ( as nurses or technicians)"\n\nAtypical Curriculum "Students from schools with non-standard anatomy curricula that already include similar 3D simulation tools"\n\nParticipation Conflicts "Currently participating in other educational research studies that could confound results"'}, 'identificationModule': {'nctId': 'NCT07031960', 'briefTitle': '3D Eye Movement Simulator for Medical Education', 'organization': {'class': 'OTHER', 'fullName': 'Isfahan University of Medical Sciences'}, 'officialTitle': 'Design, Construction and Evaluation of the Educational Effects of 3D Simulator of Human Eyeball Movements', 'orgStudyIdInfo': {'id': 'IR.ARI.MUI.REC.1404.051'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3D Eyeball Movement Simulator Group', 'description': '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.', 'interventionNames': ['Device: 3D Eyeball Movement Simulator Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Teaching Methods Group', 'description': '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.', 'interventionNames': ['Other: Conventional Teaching Methods Group']}], 'interventions': [{'name': '3D Eyeball Movement Simulator Group', 'type': 'DEVICE', 'description': '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."', 'armGroupLabels': ['3D Eyeball Movement Simulator Group']}, {'name': 'Conventional Teaching Methods Group', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Conventional Teaching Methods Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mehrnoush Malekzadeh, Ph.D', 'role': 'CONTACT', 'email': 'mehrnoush.malekzadeh@med.mui.ac.ir', 'phone': '09133097258'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isfahan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'mehrnoush malekzadeh', 'investigatorAffiliation': 'Isfahan University of Medical Sciences'}}}}