A Prospective, Randomized Controlled Split-face Trial of a Fractional Microneedle Radiofrequency Device（FMR） and Fractional Erbium-Doped Glass 1,565-nm Device(NAFL) Therapy in Baggy Lower Eyelids
Phase: NA
Conditions: Photoaging
Sponsor: Xijing Hospital

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Appendix 1: Template of clinical research plan
Project source and number: Self-selected topic
Plastic surgery clinical research project
Leader Unit: Xijing Hospital
Project Leader:Xianjie Ma
Department:Plastic surgery
Tel:+86 29 8477 5301
E-mail:majing@fmmu.edu.cn
Participating Unit: Xijing Hospital
Study Period:Jan 01,2018-Jan 01,2020
Version Number:V 2.0
Version date:Dec 08,2017

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Summary project
一、Research Program
Project name
Comparison of clinical efficacy of golden microneedles and
1565nm non-ablative dot matrix laser in the treatment of eyelid
pouches
Purpose of the
Study
The purpose of this test is to compare the efficacy of golden
microneedles and 1565nm non-ablative dot matrix laser in the
treatment of eyelid pouches.
Type of study
Randomized, double-blind, self-controlled study
Number of cases
16
Inclusion
and
Exclusion
Criteria
Inclusion Criteria:
1. Patients with blepharoplasty;
2. Fitzpatrick III-V;
3. Males and females between 18-60 years old.
Exclusion criteria:
1. Other diseases that can cause pathological changes in
periorbital soft tissue, such as collagen disease, kidney disease,
liver
cirrhosis,
Graves
disease,
diabetes,
scleroderma,
hyperlipidemia,
myasthenia
gravis,
Horner
syndrome,
myosermatitis etc;
2. Other diseases affecting wound healing, such as systemic
diseases such as diabetes, heart disease, hypertension, infectious
diseases such as tuberculosis, hepatitis, skin diseases, tumors,
etc.; such as dry eye syndrome, cataract, glaucoma ophthalmic
diseases.
3. Take steroids, vasodilators, anticoagulants (warfarin, non-
steroidal anti-inflammatory drugs, aspirin, heparin, etc.) and
retinoids 2 weeks before surgery. Local infections on the skin.

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4.Patients with blepharoplasty, periorbital laser, botulinum toxin
type A treatment history, and herpes simplex virus (HSV)
infection history 6 months before surgery. History of exposure 2
months before surgery.
5.Scar physical, pregnancy, bilateral asymmetrical eye bags.
Before entering the group, they were informed of their risks,
benefits, and possible complications after the operation, and
signed an informed consent.
6.Can not guarantee treatment on time, those who fail to
cooperate.
Treatment
options
16
patients
with
blepharoplasty
bags,
and
two
bilateral
blepharoplasty bags were treated with laser respectively, and
subjective adverse reactions (pain, burning, and burnout) were
recorded before treatment, 4 weeks after each treatment, and 12
and 24 weeks after the third treatment. Itching, dryness),
objective
adverse
reactions
(erythema,
pimples,
edema,
exudation, bleeding, scabbing, infection), patient satisfaction
VAS
score,
visa
skin
tester,
3D
skin
test,
ultrasound
measurement of lower eyelid fat volume every 4 weeks Treat
once and treat three times per person.
Efficacy
evaluation
Effectiveness evaluation indicators:
1.Patient satisfaction
2.Wrinkles, texture and pores by VISIA
3.3D data changes
4.Ultrasound measurement of BLEs volume.
Safety evaluation indicators:
1.Subjective adverse reactions-pain, burning, itching, dryness
2.Objective adverse reactions-erythema, pimples, edema,
exudation, bleeding, crusting, infection.
Statistical
The pain of the left and right lower eyelids was tested by paired t

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methods
test, the changes of various indexes of visia, 3D, and ultrasound
were compared with the Wilcoxon symbol rank test of paired
samples, and the subjective and objective adverse reactions were
tested by χ2 test.
Study period
2 years
二、Research process
Every 4 Weeks×3 Times
16 BLEs patients
(Baggy Lower Eyelids )
FMR side
(Fractional Microneedle Radiofrequency )
NAFL side
(Non-ablative Fractional Laser)
Efficacy
evaluation 1
Efficacy
evaluation 2