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

NCT ID: NCT05865860

Last Updated: 2023-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-04-13

Brief Summary

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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

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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.

Conditions

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Microsurgery Binocular Visual Function Nervous System

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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ophthalmologists with microsurgical training

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Haotian Lin, M.D., Ph.D

Role: primary

8613802793086

Andi Xu, M.D.

Role: backup

8618638355960

Other Identifiers

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2022KYPJ220

Identifier Type: -

Identifier Source: org_study_id

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