Subbrow Blepharoplasty Combined With Double Eyelid Surgery for Upper Eyelid Rejuvenation in Asian Women

Subbrow blepharoplasty combined with double eyelid surgery excising the subbrow skin and the supratarsal upper eyelid skin, lifting and fixing the OOM flap, meanwhile restoring the natural and symmetrical appearance, is a safe, effective, and durable way for treating patients presenting with dermatochalasis.

Study Overview

• Status: Unknown
• Conditions: Subbrow Blepharoplasty;Double Eyelid Surgery； Orbicularis Oculi Muscle
• Intervention / Treatment: Procedure: Subbrow Blepharoplasty Combined with Double Eyelid Surgery

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shan XI
    • Xi'an, Shan XI, China, 710032
      • Baoqiang Song

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Visual, lacrimal gland and eyelid functions were normal The eyes and eyebrows are aged between 35 and 65 years Informed consent was signed and approved by ethics review

Exclusion Criteria:

• Congenital craniofacial deformity, acquired craniofacial injury Scar constitution, pregnancy Mental illness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Subbrow Blepharoplasty Combined with Double Eyelid Surgery; An upper incision is made along the inferior margin of the eyebrow. A lower incision is determined according to necessary amount of skin excision. Then the skin and subcutaneous tissue were excised. The orbicularis oculi muscle (OOM) was separated and an OOM flap dissection was extended to the width of 15mm. A dissected OOM flap was lifted up and three transverse 3-0 nylon sutures were placed to fix it to the periosteum and then covered by the upper myocutaneous flap of the supraorbital rim. Through eyelid-crease approach the supratarsal upper eyelid skin and orbital fat was excised, adjusted and reshaped double-fold eyelids at the same time.

Procedure: Subbrow Blepharoplasty Combined with Double Eyelid Surgery; An upper incision is made along the inferior margin of the eyebrow. A lower incision is determined according to necessary amount of skin excision. Then the skin and subcutaneous tissue were excised. The orbicularis oculi muscle (OOM) was separated and an OOM flap dissection was extended to the width of 15mm. A dissected OOM flap was lifted up and three transverse 3-0 nylon sutures were placed to fix it to the periosteum and then covered by the upper myocutaneous flap of the supraorbital rim. Through eyelid-crease approach the supratarsal upper eyelid skin and orbital fat was excised, adjusted and reshaped double-fold eyelids at the same time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analog scale (VAS) scores	1, poor; 2, fair; 3, good; 4, very good; and 5, excellent	postoperative 6month

Collaborators and Investigators

• Sponsor: Xijing Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2017
• Primary Completion (ACTUAL): March 1, 2018
• Study Completion (ANTICIPATED): December 31, 2019

Study Registration Dates

• First Submitted: June 24, 2019
• First Submitted That Met QC Criteria: June 26, 2019
• First Posted (ACTUAL): June 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 28, 2019
• Last Update Submitted That Met QC Criteria: June 26, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: KY20192048-F-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No