Application and Safety Evaluation of 3D Visualization System in Microsurgical Training

Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05865860
Collaborator
(none)
42
1
15.4
2.7

Study Details

Study Description

Brief Summary

Based on the relative shortage of ophthalmic surgeons in China, the long micromanipulation cycle and the existing micromanipulation training methods have their own limitations, such as traditional operating in porcine eyes limited to synchronous guidance and evaluation, while surgical simulators are very different for the simulation of real tissues, and the price is expensive and easy to lose. Based on these, the development of a digital training system, that is, based on traditional micromanipulation platforms such as animal tissue, physical microscopic instruments supplemented by synchronous surgical guidance and evaluation, can combine the advantages of traditional training and simulator, so as to improve the efficiency of ophthalmic surgeon training, and also provide digital ideas for other disciplines based on traditionally surgical teaching.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The digital vision technology are required for the daily training of microsurgeons enrolled in our study. We only observed biological indicators of surgeons before and immediately after the operation using the digital technology, according with the prospective observational study design.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    42 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Application and Safety Evaluation of 3D Visualization System in Microsurgical Training
    Actual Study Start Date :
    Jan 1, 2023
    Anticipated Primary Completion Date :
    Apr 13, 2024
    Anticipated Study Completion Date :
    Apr 13, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    ophthalmologists with microsurgical training

    Participants underwent training by digital and microscope, and we observed the changes of functions before and immediately after the training

    Outcome Measures

    Primary Outcome Measures

    1. change of accommodative lag between pre- and post- microsurgery under digital visualization system. [5 minutes before the microsurgery and after the microsurgery within 3minutes]

      Accommodative lag was measured by Monocular estimation method (MEM) retinoscopy before and immediately after the microsurgery

    Secondary Outcome Measures

    1. heart rate variability [1 minutes before the microsurgery and after the microsurgery within 1minutes]

      Heart rate variability is the physiological phenomenon of variation in the time interval between heartbeats. It is measured by the variation in the beat-to-beat interval. We measure heart rate variability by a wearable watch

    2. surgical performance [Intraoperative (When participant performs the operation, the surgical videos is simultaneously recorded.)]

      Surgical videos were used to assess the microsurgical performance by modified Objective Structured Assessment of Technical Skill (OSATS) assessment tool.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Age:20-45 years

    • Refractive diopters: spherical: - 6.00 to + 1.00 D, cylindrical: - 1.50 to - 0 D, and binocular difference less than 1.5 D

    • Monocular best-corrected visual acuity (BCVA) ≥ 20/20

    • Normal stereoacuity (60 s of arc or better)

    Exclusion Criteria:
    • history of strabismus

    • history of systemic diseases

    • history of eye surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou Guangdong China 510060

    Sponsors and Collaborators

    • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhongshan Ophthalmic Center, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT05865860
    Other Study ID Numbers:
    • 2022KYPJ220
    First Posted:
    May 19, 2023
    Last Update Posted:
    May 19, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of May 19, 2023