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

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.

Study Overview

• Status: Recruiting
• Conditions: Microsurgery; Nervous System; Binocular Visual Function

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 Type: Observational
• Enrollment (Anticipated): 42

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Zhongshan Ophthalmic Center, Sun Yat-sen University
      • Contact: Haotian Lin, M.D., Ph.D; Phone Number: 8613802793086; Email: haot.lin@hotmail.com
      • Contact: Andi Xu, M.D.; Phone Number: 8618638355960; Email: xuand@mail2.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

ophthalmologists

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
ophthalmologists with microsurgical training; Participants underwent training by digital and microscope, and we observed the changes of functions before and immediately after the training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of accommodative lag between pre- and post- microsurgery under digital visualization system.	Accommodative lag was measured by Monocular estimation method (MEM) retinoscopy before and immediately after the microsurgery	5 minutes before the microsurgery and after the microsurgery within 3minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
heart rate variability	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	1 minutes before the microsurgery and after the microsurgery within 1minutes
surgical performance	Surgical videos were used to assess the microsurgical performance by modified Objective Structured Assessment of Technical Skill (OSATS) assessment tool.	Intraoperative (When participant performs the operation, the surgical videos is simultaneously recorded.)

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Anticipated): April 13, 2024
• Study Completion (Anticipated): April 13, 2024

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: May 17, 2023
• First Posted (Actual): May 19, 2023

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2022KYPJ220

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No