Protocol summary

Study aim
Comparison of Post Surgical Complications, Treatment Results and Patient Satisfaction of Two Different Laser Assissted Blepharoplasty of Upper Lids
Design
Randomized Clinical Trial with Parallel Group of 21 Patients, Double Blinded on Patient and Outcome assessment
Settings and conduct
In this Study, Upper Lid Bilateral Blepharoplasty will be operated in Patients with Mild to Severe Bilateral Ptosis referred to the Maxillofacial Surgery Department of Imam Khomeini Hospital. All Surgeries will be performed by the same Surgeon and the Surgical Position was randomly assigned using Digital Randomization. After Local Anesthesia, the Amount of Extra Tissue will be determined by the Pinch's Technique. On One Side, the Scalpel 15 and on the other Side the CO2 Laser is used for cutting the Skin. Other Surgical Procedures will be Laser-based. In the Area under Laser Surgery for cutting the Skin, the Program Settings 1 (Continuous Emission / Ultrapulse Mode / Power 3 W) and for Muscle cutting, the Program Settings 2 (Continuous Emission / Regular Mode / Power 9 W) will be used. After the Supratarsal Incision, the Skin and Subcutaneous Tissue are removed and the Medial Fatty Tissue will be cuttered.
Participants/Inclusion and exclusion criteria
inclusion criteria: Normal Ophtalmic Examination and Bilateral Mild to Sever Ptosis of Upper Lids exclusion criteria: Anticoagulant therapy, Coagulopathy, Disorders causing Peripheral Neuropathy such as Diabetes Mellitus, History of Trauma or Surgery of Upper lLids and Skin Disorders
Intervention groups
In Each Patient, Skin Incision was made by the Scalpel no.15 on One Side and the CO2 Laser on the Opposite Side. Other Surgical Procedures will be Same and Laser-based. Each Patient will receiv both Treatment Modalities.
Main outcome variables
Edema, Ecchymosis and Erythema Days of 1, 3, 7, 14 and 30 after Surgery and Scar at the Field of Surgery after 60 Days

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180302038917N1
Registration date: 2018-11-13, 1397/08/22
Registration timing: registered_while_recruiting

Last update: 2018-11-13, 1397/08/22
Update count: 0
Registration date
2018-11-13, 1397/08/22
Registrant information
Name
milad Alikazemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 1799
Email address
alikazemi.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Clinical Outcomes of CO2 Laser Assisted Upper Lid Blepharoplasty by Two Different Methods: a Randomized Clinical Trial Study
Public title
Comparison of CO2 Laser Assisted Upper Lid Blepharoplasty by Two Different Methods
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Normal Ophtalmic Examination Bilateral Mild to Sever Ptosis of Upper Lids
Exclusion criteria:
Anticoagulant Therapy Coagulopathy Disorders Causing Peripheral Neuropathy such as Diabetes Mellitus History of Trauma or Surgery of Upper Lids Skin Disorders
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 21
More than 1 sample in each individual
Number of samples in each individual: 2
each one of the left and right upper lid will receive one of two determined surgical modalities
Randomization (investigator's opinion)
Randomized
Randomization description
Through Software, 21 series (as 21 patients) are randomized between numbers of 1 (as the Blade and Laser group) or 2 (the Laser group alone). (www.randomizer.org). In each patient, selected number will determine surgical approach of the right eye. The left eye will be treated by the opposite approach.
Blinding (investigator's opinion)
Double blinded
Blinding description
Although Each Patient will be informed about the Application of Two Surgical Methods , the Treatment Modality of Each Lid will not be determined. Post Operation Instructions will be Same in Two Lids. The Person Responsible for Evaluation of Treatment Results in Predetermined Time Sequence will score each Lid Blinded on 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 Ahvaz University of Medical Sciences
Street address
Oral and Maxillofacial Surgery Department, Imam Khomeini Hospital, Azadegan street
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Approval date
2017-12-27, 1396/10/06
Ethics committee reference number
IR.AJUMS.REC.1396.766

Health conditions studied

1

Description of health condition studied
Bilateral Mild to Sever Ptosis of Upper lids
ICD-10 code
H02.4
ICD-10 code description
Ptosis of eyelid

Primary outcomes

1

Description
scar at the field of surgery
Timepoint
after 60 days
Method of measurement
Manchester scar scale

2

Description
Edema
Timepoint
days of 1, 3, 7, 14 and 30 after surgery
Method of measurement
Likert scale

3

Description
Ecchymosis
Timepoint
days of 1, 3, 7, 14 and 30 after surgery
Method of measurement
Likert scale

4

Description
Erythema
Timepoint
days of 1, 3, 7, 14 and 30 after surgery
Method of measurement
Likert scale

Secondary outcomes

1

Description
Patients satifaction
Timepoint
after 60 days
Method of measurement
Likert Scale

Intervention groups

1

Description
Intervention group 1: On One Side is used for cutting the Skin. Other Surgical Procedures will be Laser-based.
Category
Treatment - Surgery

2

Description
Intervention group 2: On the other Side the CO2 Laser is used for cutting the Skin. Other Surgical Procedures will be Laser-based. In the Area under Laser Surgery for cutting the Skin, the Program Settings 1 (Continuous Emission / Ultrapulse Mode / Power 3 W/tip size 0.2) and for Muscle cutting, the Program Settings 2 (Continuous Emission / Regular Mode / Power 9 W/tip size 0.2) will be used.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Mohammad Reza Fallahi
Street address
Azadegan street
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3322 2818
Email
fallahi.h@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
mohammad badavi
Street address
Azadegan street, Imam Khomeini Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3373 8383
Email
badavi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Milad Alikazemi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Oral and Maxillofacial Surgery
Street address
Azadegan street, Imam Khomeini Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3322 2818
Email
alikazemi.m@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hamid Reza Fallahi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Oral and Maxillofacial Surgery
Street address
Azadegan street, Imam Khomeini Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61332222818
Email
fallahi.h@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Milad Alikazemi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Oral and Maxillofacial Surgery
Street address
Azadegan street, Imam Khomeini Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3322 2818
Email
alikazemi.m@ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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