An observational study in Eyelid Tumor, Xanthelasma Palpebrarum and Pigmented Nevi, sponsored by Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-03-07.
Sponsored by Sun Yat-sen University · Observational
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.
-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
19 studies on the registry are indexed under Nevus, Pigmented; 6 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 50 across 11 observational studies indexed under Nevus, Pigmented.
Browse Nevus, Pigmented studies →Sun Yat-sen University is the lead sponsor of 1,690 studies on the registry; 619 are open to participants now.
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A cohort of 1000 patients with eyelid tumors, including various types of tumors. Inclusive of xanthelasma, pigmented nevi, keratoses, and so on.
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Exclusion Criteria:
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
Also known as: CO2 Laser
Clearance rate
The lesion clearance rate was classified as the proportion of the lesion cleared (\<50%; 50-75%; 76-99%; or \>99%).
Time frame: 12 months
Recurrence rate
Recurrence was defined as the regrowth of a new xanthelasma lesion within the previously excised area.
Time frame: 12 months
Postoperative complications
Lesion recurred, minor trichiasis, partial sparse to absent eyelashes, hypertrophic scar, hyperpigmentation
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Number of treatment sessions
Number of treatment sessions for complete clearance
Time frame: 12 months
Plan to share: No
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