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Evaluation of the Safety and Efficacy of SIERRA VISION SYSTEM® for vitreoretinal surgery

Evaluation of the Safety and Efficacy of SIERRA VISION SYSTEM® for vitreoretinal surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111387
Enrollment
Unknown
Registered
2025-10-30
Start date
2025-11-04
Completion date
Unknown
Last updated
2025-11-03

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

Conditions

Diseases requiring vitrectomy

Interventions

Experimental group:Vitrectomy

Sponsors

Fudan University Affiliated Eye, Ear, Nose and Throat Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patients planning to undergo vitrectomy 2. Patient age:>= 18 years 3. General condition meets surgical requirements 4. Voluntarily participate in this clinical trial and sign the subject's informed consent form 5. Patients meeting stage V DR criteria according to "China's Clinical Diagnosis and Treatment Guidelines for Diabetic Retinopathy (2022)"

Exclusion criteria

Exclusion criteria: 1. Patients with a history of ophthalmic surgery 2. Severe cardiopulmonary insufficiency or coagulation disorders 3. History of ocular infection within three months prior to screening, history of glaucoma, monocular patients, or equivalent spherical refractive error <= -6.00 D 4. Patients with retinopathy in both eyes requiring simultaneous vitrectomy treatment 5. Pregnant and lactating women, or those planning to become pregnant during the study period 6. Patients who are difficult to cooperate with 7. Other patients considered by the investigator to be unsuitable for participation in the clinical trial

Design outcomes

Primary

MeasureTime frame
Surgery success rate;

Secondary

MeasureTime frame
Total surgical time; Phacoemulsification time (if applicable); Core vitrectomy time;Membrane peeling time (if applicable); Intraoperative IOP;BCVA(logMAR);Retinal reattachment rate (if applicable);

Countries

China

Contacts

Public ContactXu Gezhi

Fudan University Affiliated Eye, Ear, Nose and Throat Hospital

drxugezhi@163.com+86 21 6437 7134

Outcome results

None listed

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