Efficacy and Safety of Ultrapulse Carbon Dioxide Laser Treatment in Eyelid Tumors

This study aims to assess the long-term efficacy and safety of ultrapulse carbon dioxide (CO₂) laser excision in the treatment of eyelid tumors, including xanthelasma, pigmented nevi, keratoses, and so on.

Study Overview

• Status: Recruiting
• Conditions: Keratosis; Eyelid Tumor; Pigmented Nevi; Xanthelasma Palpebrarum
• Intervention / Treatment: Procedure: Ultra-pulsed Carbon Dioxide Laser

Detailed Description

-Background: The assessment of the efficacy and safety of Ultrapulse CO₂ laser in treating eyelid lesions is crucial for clinical applications. This study aims to evaluate the effectiveness of super-pulsed CO₂ laser in treating different types of eyelid lesions, particularly marginal and large lesions, to provide comprehensive clinical guidance and decision support.

-Main Objectives: A retrospective analysis of the efficacy and safety of Ultrapulse CO₂ laser treatment for various types of eyelid lesions, including xanthelasma, pigmented nevi, keratoses, and so on.

-Study Design: This study will include 1000 patients diagnosed with eyelid lesions, including xanthelasma, pigmented nevi, keratoses, and so on. All patients undergoing Ultrapulse CO₂ laser treatment. The evaluation will focus on the efficacy and safety of Ultrapulse CO₂ laser treatment for different types of eyelid lesions.

-Study Population and Anticipated Enrollment: Patients with eyelid lesions (n=1000)

-Inclusion Criteria: Clinically diagnosed with eyelid lesions, including xanthelasma, pigmented nevi, keratoses, and so on.

No history of photosensitivity, bleeding, or coagulation disorders Willing to attend follow-up appointments as scheduled

-Exclusion Criteria: Presence of infection in the target area Allergy to lidocaine Keloid-prone or poor skin repair ability Pregnant or lactating Recent history of severe infectious diseases, active skin diseases, or major diseases affecting the cardiovascular, liver, kidney, endocrine, and hematopoietic systems History of malignant tumors or immune system disorders

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Dingqiao Wang, PhD; Phone Number: 13976031334; Email: wangdingqiao@163.com

Study Locations

• China
  • Guanzhou, China
    • Recruiting
    • Sun Yat-sen University
    • Contact: Xianchai Lin, Doctor; Phone Number: 13922244056; Email: linxch7@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A cohort of 1000 patients with eyelid tumors, including various types of tumors. Inclusive of xanthelasma, pigmented nevi, keratoses, and so on.

Description

Inclusion Criteria:

• Clinically diagnosed with eyelid lesions, including xanthelasma, pigmented nevi, keratoses, and so on.
• No history of photosensitivity, bleeding, or coagulation disorders
• Willing to attend follow-up appointments as scheduled

Exclusion Criteria:

• Presence of infection in the target area
• Allergy to lidocaine
• Keloid-prone or poor skin repair ability
• Pregnant or lactating
• Recent history of severe infectious diseases, active skin diseases, or major diseases affecting the cardiovascular, liver, kidney, endocrine, and hematopoietic systems
• History of malignant tumors or immune system disorders

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ultrapulse Carbon Dioxide Laser; The study investigates the use of the Ultrapulse Carbon Dioxide Laser for the excision of eyelid lesions, including xanthelasma, pigmented nevi, keratoses, and so on.	Procedure: Ultra-pulsed Carbon Dioxide Laser; Excision of eyelid lesion; Other Names: CO2 Laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clearance rate	The lesion clearance rate was classified as the proportion of the lesion cleared (<50%; 50-75%; 76-99%; or >99%).	12 months
Recurrence rate	Recurrence was defined as the regrowth of a new xanthelasma lesion within the previously excised area.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Lesion recurred, minor trichiasis, partial sparse to absent eyelashes, hypertrophic scar, hyperpigmentation	12 months
Investigator's Global Assessment (IGA) score	Investigator's Global Assessment (IGA) score for measuring improvement in clinical outcomes: 1=worsened; 2=no change; 3=minor improvement; 4=moderate improvement; 5=marked improvement; 6=near-total improvement; and 7=total improvement.	12 months
Patient satisfaction score	Patient satisfaction was evaluated subjectively by the physician on a f ve-point scale, as follows: 0=no change; 1=minor improvement; 2=moderate improvement; 3=marked improvement; 4=near-total or total improvement.	12 months
Number of treatment sessions	Number of treatment sessions for complete clearance	12 months

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Xianchai Lin, PhD, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: January 4, 2024
• First Submitted That Met QC Criteria: January 4, 2024
• First Posted (Actual): January 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Eye Diseases; Head and Neck Neoplasms; Nevi and Melanomas; Eye Neoplasms; Eyelid Diseases; Facial Neoplasms; Nevus; Keratosis; Nevus, Pigmented; Eyelid Neoplasms
• Other Study ID Numbers: 2023KYPJ286

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No