Evaluation and comparison of side effects and satisfaction of patient and physician in minimally invasive inferior phenol blepharopeeling versus blepharoplasty without peeling for rejuvenation of lower lids
comparison of side effects and satisfaction of patient and physician in minimally invasive inferior phenol blepharopeeling versus blepharoplasty without peeling.
Design
A trial with parallel group design was conducted on 30 patients with lower lids herniation. The trial was single blind in which the person who evaluated the results was kept blind. The trial was conducted between October 2017 and October 2018. The period of follow up was two months.
Settings and conduct
A total of 30 patients who referred to Alzahra Hospital in Isfahan in 1396 were randomly divided into two groups of blephapeeling and blepharoplasty without peeling. All Surgeries were performed by the same surgeon. Before and 2 months after surgery photograph was taken from the patient's face. Each photograph was compared before and after surgery by two physicians and the degree of satisfaction was recorded as "low 25%, average 50%, good 75%, and excellent 100%."
Participants/Inclusion and exclusion criteria
Inclusion criteria:
skin type of 1-3 based on Fitz Patrick criteria; presentation of herniation of under eyelid located fatty tissue; lacking of tear trough deformity; over 40 years old of age; patients' willingness for participation in the study.
Non-inclusion criteria:
any history of previous local treatment; psychological diseases ; severe aging related changes in their inferior eyelid.
Intervention groups
Intervention group 1: The group of Blepharopeeling, which is treated by minimally invasive blepharoplasty with the addition of phenol peeling.
Intervention group 2: Belpharoplasty group in which blepharoplasty without peeling of lower lids is used.
Evaluation and comparison of side effects and satisfaction of patient and physician in minimally invasive inferior phenol blepharopeeling versus blepharoplasty without peeling for rejuvenation of lower lids
Public title
Effect of peeling with phenol to rejuvenate the lower eyelids
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Skin type of 1-3 based on Fitz Patrick criteria
presentation of herniation under eyelid located fatty tissue
Absence of tear trough deformity
over 40 years of age
patients' willingness for participation the study
Exclusion criteria:
Patients who presented any history of previous local treatment
history of psychological diseases
severe aging related changes in the inferior eyelid
Age
From 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is performed in a simple way. Based on the random number tables, the patients are divided into two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The person responsible for evaluation of treatment results in predetermined time sequence will score patients without knowing the treatment modality.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Deputy of research of Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Approval date
2017-07-29, 1396/05/07
Ethics committee reference number
IR.MUI.REC.1396.3.644
Health conditions studied
1
Description of health condition studied
Fat herniation of lower eyelids
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Rate of the patient's satisfaction for decrease fat herniation of lower lids
Timepoint
Two months after operation
Method of measurement
Questionnaire
2
Description
Rate of the patient's satisfaction for symmetry
Timepoint
Two months after operation
Method of measurement
Questionnaire
3
Description
Rate of the patient's satisfaction for esthetics
Timepoint
Two months after operation
Method of measurement
Questionnaire
4
Description
Rate of the patient's satisfaction for eyelid prolapse
Timepoint
Two months after operation
Method of measurement
Questionnaire
5
Description
Rate of the patient's general satisfaction
Timepoint
Two months after operation
Method of measurement
Questionnaire
6
Description
Rate of the physician's satisfaction with the lower eyelid flaccidity decrease
Timepoint
Two months after operation
Method of measurement
Observation
Secondary outcomes
1
Description
Periorbital erythema
Timepoint
Daily up to one week and then 2 weeks and 2 months after operation
Method of measurement
Visit, history and physical examination
2
Description
Hypopigmentation
Timepoint
Daily up to one week and then 2 weeks and 2 months after operation
Method of measurement
Visit, history and physical examination
3
Description
Hyperpigmentation
Timepoint
Daily up to one week and then 2 weeks and 2 months after operation
Method of measurement
Visit, history and physical examination
4
Description
Scar
Timepoint
Daily up to one week and then 2 weeks and 2 months after operation
Method of measurement
Visit, history and physical examination
5
Description
Hematoma
Timepoint
Daily up to one week and then 2 weeks and 2 months after operation
Method of measurement
Visit, history and physical examination
6
Description
Granuloma
Timepoint
Daily up to one week and then 2 weeks and 2 months after operation
Method of measurement
Visit, history and physical examination
7
Description
Infection
Timepoint
Daily up to one week and then 2 weeks and 2 months after operation
Method of measurement
Visit, history and physical examination
8
Description
Dry eye syndrome
Timepoint
Daily up to one week and then 2 weeks and 2 months after operation
Method of measurement
Visit, history and physical examination
9
Description
Edema
Timepoint
Daily up to one week and then 2 weeks and 2 months after operation
Method of measurement
Visit, history and physical examination
10
Description
Bruising
Timepoint
Daily up to one week and then 2 weeks and 2 months after operation
Method of measurement
Visit, history and physical examination
11
Description
Loss of vision
Timepoint
Daily up to one week and then 2 weeks and 2 months after operation
Method of measurement
Visit, history and physical examination
12
Description
Diplopia
Timepoint
Daily up to one week and then 2 weeks and 2 months after operation
Method of measurement
Visit, history and physical examination
13
Description
Lagophtalmos
Timepoint
Daily up to one week and then 2 weeks and 2 months after operation
Method of measurement
Visit, history and physical examination
14
Description
Asymmetry
Timepoint
Daily up to one week and then 2 weeks and 2 months after operation
Method of measurement
Visit, history and physical examination
15
Description
Ptosis
Timepoint
Daily up to one week and then 2 weeks and 2 months after operation
Method of measurement
Visit, history and physical examination
16
Description
Pain
Timepoint
Daily up to one week and then 2 weeks and 2 months after treatment start
Method of measurement
Visit, history and physical examination
Intervention groups
1
Description
Intervention group: After cleaning the face and injecting the local anesthetic in the lower eyelid region in the blepharopeeling group, peeling is performed in lower periocular region using phenol 89% and a cotton applicator until a white layer is formed. The skin and underlying muscle were incised superficially using bisturi no 15, and then underlying fat tissue excised using finger pressure, bishop forceps and curve forceps. Following excision of adequate fat tissue, remained stalk was burned using cautery. This process was performed for all marked fat pads Then, a simple suture of ethilon 5.0 is used to close the gap.
Category
Treatment - Surgery
2
Description
Control group: After injecting the local anesthetic in the blepharoplasty group, the skin and underlying muscle were incised superficially using bisturi no 15, and then underlying fat tissue excised using finger pressure, bishop forceps and curve forceps. Following excision of adequate fat tissue, remained stalk was burned using cautery. This process was performed for all marked fat pads Then, a simple suture with ethilon 5.0 is used to close the gap.