Clinical trial NCT06206681: Efficacy and Safety of Ultrapulse Carbon Dioxide Laser Treatment in Eyelid Tumors
Official title: Efficacy and Safety of Ultrapulse Carbon Dioxide Laser Treatment in Eyelid Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Eyelid Tumor
Xanthelasma Palpebrarum
Pigmented Nevi
Keratosis
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Clearance rate
timeFrame: 12 months
measure: Recurrence rate
timeFrame: 12 months
Secondary outcomes:
measure: Postoperative complications
timeFrame: 12 months
measure: Investigator's Global Assessment (IGA) score
timeFrame: 12 months
measure: Patient satisfaction score
timeFrame: 12 months
measure: Number of treatment sessions
timeFrame: 12 months
Other outcomes:
Locations:
city: Guanzhou
country: China
facility: Sun Yat-sen University
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Xianchai Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References: