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This study aims to assess the long-term efficacy and safety of ultrapulse carbon dioxide (COâ‚‚) 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 COâ‚‚ laser in treating eyelid lesions is crucial for clinical applications. This study aims to evaluate the effectiveness of super-pulsed COâ‚‚ 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 COâ‚‚ 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 COâ‚‚ laser treatment. The evaluation will focus on the efficacy and safety of Ultrapulse COâ‚‚ 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultra-pulsed Carbon Dioxide Laser | Procedure | Excision of eyelid lesion |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dingqiao Wang, PhD | Contact | 13976031334 | wangdingqiao@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xianchai Lin, PhD | Zhongshan Ophthalmic Center, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University | Recruiting | Guanzhou | China |
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| ID | Term |
|---|---|
| D005142 | Eyelid Neoplasms |
| D014973 | Xanthomatosis |
| D009508 | Nevus, Pigmented |
| D007642 | Keratosis |
| ID | Term |
|---|---|
| D005153 | Facial Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D054020 | Lasers, Gas |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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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 |
| D005134 |
| Eye Neoplasms |
| D005128 | Eye Diseases |
| D005141 | Eyelid Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D009506 | Nevus |
| D018326 | Nevi and Melanomas |
| D009370 | Neoplasms by Histologic Type |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |