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Clinical validation protocol for perfluoronaphthalene in ophthalmic surgery

Clinical validation protocol for perfluoronaphthalene in ophthalmic surgery

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054569
Enrollment
Unknown
Registered
2021-12-20
Start date
2021-10-20
Completion date
Unknown
Last updated
2022-11-28

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

Conditions

Vitreoretinal diseases

Interventions

1:perfluoronaphthalene (Suzhou Industrial Park JST Medical Equipment Co., LTD) used in surgery
2:perfluoronaphthalene (Bausch & Lomb) used in surgery

Sponsors

The First Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or above, no gender limitation; 2. The investigator determined that perfluoronaphthalene should be used in ophthalmic surgery; 3. The subjects had vitreoretinal disease; 4. The subjects or their legal representatives can understand the purpose of the study and show sufficient compliance with the study protocol and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. The researcher determined that the candidate could not be selected; 2. The subjects who participate in the drug clinical trial or medical device clinical trial less than 1 month after the end or can not go to the hospital regularly for examination; 3. Patients with primary glaucoma; 4. Women during pregnancy and breast feeding; 5. Patients have important organ failure or other serious diseases, including clinically relevant cardiovascular and cerebrovascular diseases; History of severe optic nerve; Severe infection; Active disseminated intravascular coagulation; 6. Subjects with binocular retinopathy requiring simultaneous treatment with perfluoronaphthalene for ophthalmic surgery; 7. Patients suffering from mental illness hinder treatment and evaluation.

Design outcomes

Primary

MeasureTime frame
Vital signs: blood pressure, heart rate, temperature;blood tests;residue or not;moves into the subretinal lumen or not;Lens condition;IOP;

Secondary

MeasureTime frame
anterior chamber;

Countries

Chian

Contacts

Public ContactLu Peirong

the First Affiliated Hospital of Soochow University

lupeirong@suda.edu.cn+86 13914083528

Outcome results

None listed

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