None listed
Conditions
Interventions
Biological/Vaccine, Stem Cell : The study focuses on patients who visited due to enophthalmos and are standard treatment candidates for hyaluronic acid injections. The control and experimental groups
Sponsors
Bundang CHA General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 19 to under 70 2. Diagnosed with enophthalmos due to eye atrophy caused by trauma, eye surgery, or eye diseases (such as glaucoma or uveitis) 3. Exhibiting axial shortening exceeding 1 mm compared to the other side as measured by orbital CT (includes mild enophthalmos (difference in exophthalmos values between both eyes within 2 mm, single eye exophthalmos value 14 mm or more) and moderate enophthalmos (difference in exophthalmos values between both eyes 3 mm or more, single eye exophthalmos value 13 mm or less)) 4. Patients who have signed the informed consent for Restylane? Lidocaine alone or Restylane? Lidocaine injection therapy including stromal vascular fraction * In cases of bilateral enophthalmos, the eye with more severe enophthalmos as measured during the screening visit will be selected.
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed with congenital enophthalmos 2. Patients contraindicated for local anesthesia or with a history of allergy to local anesthetics 3. Patients with a history of eye surgery in the eye to be treated within 3 months of screening 4. Patients medically unsuitable for stromal vascular fraction injection: Slight deviations from the normal range in clinical pathology tests conducted at screening will be evaluated for clinical significance by medical monitors and investigators. 5. Patients with a history of drug abuse based on medical inquiry 6. Patients with cognitive impairments or dementia that might affect understanding the consent or the conduct of the trial, either currently or in the past, as determined at screening 7. Patients currently participating in another clinical trial at the time of screening 8. Patients who have participated in clinical trials involving ocular or systemic drug administration within 6 months prior to screening 9. Pregnant or breastfeeding women 10. Patients with other medical conditions at the time of screening (or baseline) that, in the investigator's judgment, may interfere with the compliance of the clinical trial protocol, jeopardize the participant's safety, or affect the interpretation of clinical trial results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of adverse reactions, vital signs, clinical tests, and changes in orbital MRI results | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in ocular movement, eyelid size, degree of exophthalmos, and results of ophthalmic examinations (visual acuity, intraocular pressure, slit lamp examination, and fundus photography) | — |
Countries
Korea, Republic of
Contacts
Public ContactPark Jungyoon
Bundang CHA General Hospital
Outcome results
None listed