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Evaluation on the safety of ISPAN perfluoropropane (C3F8) for intravitreal injection

Evaluation on the safety of ISPAN perfluoropropane (C3F8) for intravitreal injection - C3F8 China PMCF

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100054892
Enrollment
Unknown
Registered
2021-12-28
Start date
2021-12-24
Completion date
Unknown
Last updated
2023-08-28

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

Conditions

Ocular fundus disease

Interventions

Perfluoropropane group:No

Sponsors

Beijing Tongren Hospital, CMU
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients whose condition is consistent with simple retinal detachment and intraoperative use of perfluoropropane is required based on the medical judgment of the investigator.If binocular surgery is planned and study products are required intraoperatively, the first operative eye that meets the criteria for placement is included. 2. At least 18 years old, able to understand and willing to sign informed consent. 3. Able to complete postoperative follow-up according to the plan. 4. They are Chinese residents.

Exclusion criteria

Exclusion criteria: 1. In the past 30 days, the subject has participated in other clinical study. 2. The subject has any reported contraindications to ISPAN perfluoropropane (C3F8).

Design outcomes

Primary

MeasureTime frame
Adverse events;Device defect;Second operation;—

Countries

China

Contacts

Public ContactWei Wenbin

Beijing Tongren Hospital, CMU

tr_weiwenbin@163.com+86 10 5826 8267

Outcome results

None listed

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