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

NCT05865860 | Unknown

• 1 other identifier: 2022KYPJ220
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Microsurgery; Binocular Visual Function; Nervous System

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• heart rate variability

  1 minutes before the microsurgery and after the microsurgery within 1minutes

• surgical performance

  Intraoperative (When participant performs the operation, the surgical videos is simultaneously recorded.)

Study Arms (1)

ophthalmologists with microsurgical training

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

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

ophthalmologists

You may qualify if:

• 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)

You may not qualify if:

• history of strabismus
• history of systemic diseases
• history of eye surgery

Sponsors & Collaborators

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

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Neurologic Manifestations

Condition Hierarchy (Ancestors)

Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: May 19, 2023
• Study Start: January 1, 2023
• Primary Completion: April 13, 2024
• Study Completion: April 13, 2024
• Last Updated: May 19, 2023

Record last verified: 2023-01

Locations

CN (1)