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

Microsurgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05865860
• Other study ID #: 2022KYPJ220
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: April 13, 2024

Study information

• Verified date: January 2023
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: April 13, 2024
• Est. primary completion date: April 13, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Microsurgery
• Nervous System

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.)