Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05865860
Enrollment
42
Registered
2023-05-19
Start date
2023-01-01
Completion date
2024-04-13
Last updated
2023-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Binocular Visual Function, Microsurgery, Nervous System

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.

Interventions

None listed

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frameDescription
change of accommodative lag between pre- and post- microsurgery under digital visualization system.5 minutes before the microsurgery and after the microsurgery within 3minutesAccommodative lag was measured by Monocular estimation method (MEM) retinoscopy before and immediately after the microsurgery

Secondary

MeasureTime frameDescription
heart rate variability1 minutes before the microsurgery and after the microsurgery within 1minutesHeart 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 performanceIntraoperative (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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026