Tokyo, Aug. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058752) titled 'Evaluation of the Clinical Outcomes and Safety of an Improved Non-Incisional Double Eyelid Surgery: A Randomized, Open-Label, Two-Arm Parallel Trial' on Aug. 10.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Tokyo Chuo Beauty Clinic (TCB), BS Clinic, Umeda Osaka Ekimae Branch
Condition:
Condition - cosmetic blepharoplasty candidates
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - In double eyelid surgery, the first suture insertion point on the medial side is considered the most critical factor in determining clinical outcomes. However, it is also the most common site of fixation loss. This study aims to compare a modified technique, in which the first insertion point is anchored in the dermis, with the conventional method, to evaluate their respective effects on the durability of the eyelid crease.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - A modified technique, in which the first insertion point is anchored in the dermis, with the conventional method.
Interventions/Control_2 - The conventional method.
Eligibility:
Age-lower limit - 10
years-old
=
Gender - Male and Female
Key inclusion criteria - Patients
who wish to undergo buried suture double-eyelid Surgery.
who have provided written informed consent for this treatment.
Key exclusion criteria - Patients
who have exhibited allergic reactions to anesthetic compounds,
who have severe skin laxity.
Target Size - 100
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 06 Month 20 Day
Date of IRB - 2025 Year 06 Month 21 Day
Anticipated trial start date - 2025 Year 06 Month 26 Day
Last follow-up date - 2026 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067180
Disclaimer: Curated by HT Syndication.
