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IRCT20230824059245N1 IRCT 2026-08-04 Ahvaz University of Medical Sciences Comparison of the effect of CO2 laser and scalpel surgery on scar quality in upper eyelid blepharoplasty Comparison of Incision Site Scarring in Upper Eyelid Blepharoplasty Using CO2 Laser Versus Cold Steel Scalpel: A Non-Randomized Pilot Clinical Trial Study 2026-08-11 anticipated 20 Recruiting https://irct.ir/trial/91339 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: Because of the nature of the surgical intervention, blinding of the surgeon and participants is not feasible. Therefore, the study is designed as a single-blind clinical trial. To implement blinding, standardized photographs will be obtained from all participants before surgery and at the 60-day follow-up under identical conditions (camera angle, distance, lighting, and patient position). All photographs will be coded with unique identification numbers, and no information regarding the intervention (CO₂ laser or cold steel scalpel) will be available to the outcome assessors. Scar quality will be evaluated using the Manchester Scar Scale by three independent assessors who are not involved in the surgical procedures or patient allocation and are fully blinded to the intervention received. In addition, the statistical analyst will receive a coded dataset (e.g., Group A and Group B) without access to treatment allocation, and statistical analyses will be performed while remaining blinded to the intervention groups. N/A Upper Eyelid Blepharoplasty. Intervention 1: Intervention group: Upper eyelid blepharoplasty is performed using a CO₂ laser (Edge One, Jeisys, South Korea). An antibiotic-ointment-soaked eye shield is used for ocular protection. Laser settings include Continuous Wave mode, 100f tip, and 1 W power for the initial incision, and 3 W power for tissue excision. Local anesthesia is administered using 2% lidocaine with epinephrine (1:100,000), and the wound is closed with 6-0 nylon simple interrupted sutures. Intervention 2: Control group: Upper eyelid blepharoplasty is performed using a No. 15 surgical scalpel. Hemostasis is achieved using an electrocautery device in coagulation mode. Local anesthesia is administered using 2% lidocaine with epinephrine (1:100,000), and the wound is closed with 6-0 nylon simple interrupted sutures. 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 Still undecided - no release schedule yet
public Nader Pazyar
Imam Khomeini Hospital., 24 Meters., Azadegan St
Ahvaz Iran (Islamic Republic of) 6193673166 +98 918 861 7133 pazyar-n@ajums.ac.ir Ahvaz University of Medical Sciences scientific Nader Pazyar
Imam Khomeini Hospital., 24 Meters., Azadegan St
Ahvaz Iran (Islamic Republic of) 6193673166 +98 918 861 7133 pazyar-n@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Being a candidate for blepharoplasty according to the dermatologist's opinion and not having any eye problems that would prevent the surgery Age range between 30 and 60 years 30 years 60 years Both Refusal to participate in the study Refusal to undergo blepharoplasty Refusal to undergo CO₂ laser blepharoplasty Coagulation disorders Current use of anticoagulant medications Abnormal coagulation test results (PT, PTT, INR, BT, or CT) Previous eyelid surgery History of eyelid trauma Active skin disease of the eyelid Active eyelid infection Immunodeficiency disorders Human immunodeficiency virus (HIV) infection Hepatitis B infection Hepatitis C infection Diabetes mellitus with neuropathy History of keloid formation H02.4 Ptosis of eyelid Treatment - Surgery Treatment - Surgery Intervention group: Upper eyelid blepharoplasty is performed using a CO₂ laser (Edge One, Jeisys, South Korea). An antibiotic-ointment-soaked eye shield is used for ocular protection. Laser settings include Continuous Wave mode, 100f tip, and 1 W power for the initial incision, and 3 W power for tissue excision. Local anesthesia is administered using 2% lidocaine with epinephrine (1:100,000), and the wound is closed with 6-0 nylon simple interrupted sutures. Control group: Upper eyelid blepharoplasty is performed using a No. 15 surgical scalpel. Hemostasis is achieved using an electrocautery device in coagulation mode. Local anesthesia is administered using 2% lidocaine with epinephrine (1:100,000), and the wound is closed with 6-0 nylon simple interrupted sutures. Manchester Scar Scale score. Timepoint: Day 60 after surgery. Method of measurement: Scar score will be assessed on postoperative day 60 by three blinded assessors using the Manchester Scar Scale. Ahvaz University of Medical Sciences Approved 2026-06-27 Ethics Committee of Ahvaz Jundishapur University of Medical Sciences Jundishapur University of Medical Sciences، Koi Golestan، Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)