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Exploratory Study of SIERRA VISION SYSTEM® for Posterior Segment Surgery

Exploratory Study of SIERRA VISION SYSTEM® for Posterior Segment Surgery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111138
Enrollment
Unknown
Registered
2025-10-27
Start date
2025-11-02
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

Trial group:Completion of vitrectomy using the investigational device.

Sponsors

Shanghai Aier Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients scheduled to undergo vitrectomy who have not previously had the procedure 2. Patient age: >=18 years 3. General health condition meets surgical requirements 4. Willing to sign informed consent form

Exclusion criteria

Exclusion criteria: 1. Patients who have previously undergone ophthalmic surgery 2. Patients with recent history of eye infection, monocular vision, or low vision in one eye 3. Patients who have difficulty cooperating

Design outcomes

Primary

MeasureTime frame
Surgery completion rate;

Secondary

MeasureTime frame
Iatrogenic intraoperative complications related to the experimental device;Cutting Efficiency (Performance Evaluation Table);Mean perfusion pressure during surgery;BCVA(logMAR);Electrocoagulation hemostasis efficiency (average output energy);System failure rate;Average output energy;

Countries

China

Contacts

Public ContactHu Yuntao

Shanghai Aier Eye Hospital

huyuntao2@aierchina.com+86 21 6295 6699

Outcome results

None listed

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