MicrosurgeryNCT05865860
Application and Safety Evaluation of 3D Visualization System in Microsurgical Training
An observational study of Microsurgery and Binocular Visual Function, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Microsurgery, Binocular Visual Function, Nervous System
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 13 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: ophthalmologists
Who may be able to join
- 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)
Who cannot join
- history of strabismus
- history of systemic diseases
- history of eye surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Haotian Lin, M.D., Ph.D, 8613802793086, haot.lin@hotmail.com
Andi Xu, M.D., 8618638355960, xuand@mail2.sysu.edu.cn
About this study
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.
Read the 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.
- Conditions
- Microsurgery, Binocular Visual Function, Nervous System
- Medical subject headings
- Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ophthalmologists with microsurgical training | Participants underwent training by digital and microscope, and we observed the changes of functions before and immediately after the training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 minutes before the microsurgery and after the microsurgery within 3minutes
Secondary outcomes (2)
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
Measured: 1 minutes before the microsurgery and after the microsurgery within 1minutes
surgical performance
Surgical videos were used to assess the microsurgical performance by modified Objective Structured Assessment of Technical Skill (OSATS) assessment tool.
Measured: Intraoperative (When participant performs the operation, the surgical videos is simultaneously recorded.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start1 Jan 2023
- Primary completion13 Apr 2024 (estimated)
- Study completion13 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrosurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865860
- Sponsor's protocol ID
- 2022KYPJ220
- Status last verified
- Jan 2023
- First submitted
- 28 Mar 2023
- Last updated
- 19 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application and Safety Evaluation of 3D Visualization System in Microsurgical Training
- ClinicalTrials.gov ID
- NCT05865860
- Acronym / sponsor ID
- 2022KYPJ220
- Conditions
- Microsurgery, Binocular Visual Function, Nervous System
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 13 Apr 2024 (estimated)
- Study completion
- 13 Apr 2024 (estimated)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ophthalmologists with microsurgical training | – | –Participants underwent training by digital and microscope, and we observed the changes of functions before and immediately after the training |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- ophthalmologists
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- history of strabismus
- history of systemic diseases
- history of eye surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change of accommodative lag between pre- and post- microsurgery under digital visualization system.
Time frame: 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
2 secondary outcomes
heart rate variability
Time frame: 1 minutes before the microsurgery and after the microsurgery within 1minutes
surgical performance
Time frame: Intraoperative (When participant performs the operation, the surgical videos is simultaneously recorded.)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microsurgery and Binocular Visual Function, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of accommodative lag between pre- and post- microsurgery under digital visualization system. (time frame: 5 minutes before the microsurgery and after the microsurgery within 3minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.