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

NCT06206681 | Recruiting

• 1 other identifier: 2023KYPJ286
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Eyelid Tumor; Xanthelasma Palpebrarum; Pigmented Nevi; Keratosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Postoperative complications

  12 months

• Investigator's Global Assessment (IGA) score

  12 months

• Patient satisfaction score

  12 months

• Number of treatment sessions

  12 months

Study Arms (1)

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

Interventions

Ultra-pulsed Carbon Dioxide Laser PROCEDURE

Excision of eyelid lesion

Also known as: CO2 Laser

Ultrapulse Carbon Dioxide Laser

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University

Guanzhou, China

RECRUITING

MeSH Terms

Conditions

Eyelid Neoplasms; Xanthomatosis; Nevus, Pigmented; Keratosis

Interventions

Lasers, Gas

Condition Hierarchy (Ancestors)

Facial Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Eye Neoplasms; Eye Diseases; Eyelid Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Nevus; Nevi and Melanomas; Neoplasms by Histologic Type; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Xianchai Lin, PhD

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dingqiao Wang, PhD

CONTACT

13976031334; wangdingqiao@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 16, 2024
• Study Start: November 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: September 1, 2025
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)