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IRCT20180302038917N1 IRCT 2018-11-13 Ahvaz University of Medical Sciences Comparison of CO2 Laser Assisted Upper Lid Blepharoplasty by Two Different Methods Comparison of Clinical Outcomes of CO2 Laser Assisted Upper Lid Blepharoplasty by Two Different Methods: a Randomized Clinical Trial Study 2018-09-23 anticipated 21 Complete https://irct.ir/trial/32718 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Bilateral Mild to Sever Ptosis of Upper lids. Intervention 1: Intervention group 1: On One Side is used for cutting the Skin. Other Surgical Procedures will be Laser-based. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Milad Alikazemi
Azadegan street, Imam Khomeini Hospital
Ahvaz Iran (Islamic Republic of) 6193673166 +98 61 3322 2818 alikazemi.m@ajums.ac.ir Ahvaz University of Medical Sciences scientific Hamid Reza Fallahi
Azadegan street, Imam Khomeini Hospital
Ahvaz Iran (Islamic Republic of) 6193673166 +98 61332222818 fallahi.h@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Normal Ophtalmic Examination Bilateral Mild to Sever Ptosis of Upper Lids 20 years 60 years Both Anticoagulant Therapy Coagulopathy Disorders Causing Peripheral Neuropathy such as Diabetes Mellitus History of Trauma or Surgery of Upper Lids Skin Disorders H02.4 Ptosis of eyelid Treatment - Surgery Treatment - Surgery Intervention group 1: On One Side is used for cutting the Skin. Other Surgical Procedures will be Laser-based. 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. Scar at the field of surgery. Timepoint: after 60 days. Method of measurement: Manchester scar scale. Edema. Timepoint: days of 1, 3, 7, 14 and 30 after surgery. Method of measurement: Likert scale. Ecchymosis. Timepoint: days of 1, 3, 7, 14 and 30 after surgery. Method of measurement: Likert scale. Erythema. Timepoint: days of 1, 3, 7, 14 and 30 after surgery. Method of measurement: Likert scale. Patients satifaction. Timepoint: after 60 days. Method of measurement: Likert Scale. Ahvaz University of Medical Sciences Approved 2017-12-27 Ethics committee of Ahvaz University of Medical Sciences Oral and Maxillofacial Surgery Department, Imam Khomeini Hospital, Azadegan street Ahvaz Khouzestan Iran (Islamic Republic of)