Infraorbital depression
Conditions
Interventions
Test group:Treated with a trial device for bilateral infraorbital filling
Control group:Do not receive treatment
Sponsors
Guangdong Second Provincial General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1)?? Aged >=18 and <=65 years, gender-neutral. ??(2)?? Subjects who desire correction of bilateral infraorbital depressions. ??(3)?? Blinded investigator-assessed severity of bilateral infraorbital depressions rated as grade 2-3 (moderate to severe), with bilateral scores allowed to differ. ??(4)?? Subjects capable and willing to follow the investigator's instructions, adhere to protocol requirements, and complete all required visits. ??(5)?? Voluntarily agree to participate in this clinical trial and sign the informed consent form. (4) Those who are able and willing to follow the instructions of the investigator, follow the protocol and are willing to complete the visit as required; (5) Voluntarily participate in this clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1)?? Subjects diagnosed by the investigator with diseases that may affect the safety of neurovascular structures or ocular regions, including but not limited to ocular diseases interfering with visual function, exophthalmos, facial spasm, or facial ptosis; and/or bilateral corrected visual acuity or uncorrected visual acuity 1.5× upper limit of normal) or on anticoagulants (e.g., warfarin) that increase bleeding risk at the implant site. ??(11)?? Subjects with severe systemic diseases (e.g., ALT/AST >2.5× ULN, creatinine >1.5× ULN, myocardial infarction within 6 months) deemed unsuitable by the investigator. ??(12)?? Subjects undergoing chemotherapy and/or radiotherapy. ??(13)?? Subjects with severe neurological or psychiatric disorders impairing comprehension or cooperation (e.g., epilepsy, severe mental illness). ??(14)?? Pregnant/lactating women or those planning pregnancy during the trial. ??(15)?? Subjects with unre
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blinded Investigator Scoring for AIHS (Infraorbital Hollow Severity Scale)?; | — |
Secondary
| Measure | Time frame |
|---|---|
| injector-investigator Scoring for AIHS (Infraorbital Hollow Severity Scale)?;injector-investigator Scoring for GAIS(Global Aesthetic Improvement Scale); Satisfaction evaluation;NRS; | — |
Countries
China
Contacts
Public ContactLuo Shengkang
Guangdong Second Provincial General Hospital
Outcome results
None listed