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5G-Based Teleoperated Microsurgical Control System for Ophthalmic Surgery in Assisting Subretinal Injection

Exploratory Study on the Safety and Efficacy Evaluation of a 5G-Based Teleoperated Microsurgical Control System for Ophthalmic Surgery in Assisting Subretinal Injection

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108262
Enrollment
Unknown
Registered
2025-08-27
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-09-01

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

Conditions

Subretinal bleeding and spread to the fovea, the bleeding scope of more than 1 optic disc diameter, subretinal thrombolysis drug injection is required,best-corrected visual acuity (BCVA) of =0.3 in log of the minimum angle of resolution (logMAR) units.

Interventions

Experimental group:5G-Based Teleoperated Microsurgical Control System for Ophthalmic Surgery in Assisting Subretinal Injection

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >=18 years,gender is not limited; 2.The affected eye,subretinal hemorrhage with spread to fovea; 3.The affected eye,bleeding scope of more than 1 optic disc diameter, best-corrected visual acuity (BCVA) of =0.3 in log of the minimum angle of resolution (logMAR) units; 4.The affected eye, upon the investigator's evaluation, requires subretinal injection of thrombolytic medication; 5.Voluntarily participate in this clinical study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Severe coagulation dysfunctiorn(APTT>1.5 times the upper limit of normal value of testing institutions), there are obvious symptoms Blood tendency; 2.Marfan syndrome or abnormal suspensory ligaments of crystals; 3.Uveitis is present; 4.Severe macular atrophy, or severe subfoveal scarring; 5.Scleritis or associated with thin sclera; 6.Patients judged unsuitable for vitreoretinal surgery, such as: endophthalmitis, severe Red iris, severe atrophy of the eyeball; 7.People with combined cognitive or mental impairment, inability to understand and cooperate; 8.People with combined cognitive or mental impairment, inability to understand and cooperate; 9.Unable to complete interviewers on time; 10.Pregnant and lactating women and those who had a birth plan during the experiment; 11.Subjects who are currently participating in other clinical trials involving investigational drugs or medical devices and have not yet completed the study; 12.The researchers did not consider participants suitable for this study;

Design outcomes

Primary

MeasureTime frame
Remote Surgery Success Rate;

Secondary

MeasureTime frame
Insertion depth;Task load;Network Transmission Evaluation (Network Signal Delay; Total Latency; Packet Loss Rate);Degree of tremor;Instrument performance satisfaction;Surgical parameters (injection time, injection dose, injection rate);

Countries

China

Contacts

Public ContactLin Lv

The Zhongshan Ophthalmic Center,Sun Yat-sen University

lvlin@gzzoc.com+86 20 66610729

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026