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

Recruiting

• Conditions: Binocular Visual Function; Nervous System; Microsurgery

• Registration Number: NCT05865860
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

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.

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 Timeline

• Status Verified: 2023-01
• Study Start: 2023-01-01
• Study First Submitted: 2023-03-28
• Study First Submitted QC: 2023-05-17
• Last Update Submitted: 2023-05-17
• Study First Posted: 2023-05-19
• Last Update Posted: 2023-05-19
• Primary Completion: 2024-04-13
• Study Completion: 2024-04-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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.

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China