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

Sponsor
Xijing Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04001660
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
28
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Subbrow Blepharoplasty Combined with Double Eyelid Surgery
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Subbrow Blepharoplasty Combined With Double Eyelid Surgery for Upper Eyelid Rejuvenation in Asian Women
Actual Study Start Date :
Sep 1, 2017
Actual Primary Completion Date :
Mar 1, 2018
Anticipated Study Completion Date :
Dec 31, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. visual analog scale (VAS) scores [postoperative 6month]

    1, poor; 2, fair; 3, good; 4, very good; and 5, excellent

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Baoqiang Song Xi'an Shan XI China 710032

Sponsors and Collaborators

  • Xijing Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT04001660
Other Study ID Numbers:
  • KY20192048-F-2
First Posted:
Jun 28, 2019
Last Update Posted:
Jun 28, 2019
Last Verified:
Jan 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 28, 2019