Clinical trial NCT05645341: Artificial Intelligence-assisted Screening of Malignant Pigmented Tumors on the Ocular Surface
Official title: Artificial Intelligence-assisted Screening of Malignant Pigmented Tumors on the Ocular Surface
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orbital Neoplasms
Conjunctival Neoplasms
Eye Neoplasms
Keywords: Mobile health
Artificaial intelligence medicine
Ocular surface malignant tumor
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 535
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Through the offline specialist clinics, online popular science, news reports, and other channels, we will promote and inform the crowd about the relevant knowledge of pigmented tumors on the ocular surface, so that they can judge by themselves that they are eligible to join the group, and freely decide whether to participate in this study or not.

Brief summary: Rare diseases generally refer to diseases whose prevalence rate is lower than 1 / 10 000 and the number of patients is less than 140000. Rare diseases are generally faced with the dilemma of a lack of qualified doctors, difficulty in large-scale screening, and a lack of rapid and effective channels for medical treatment. Studies have shown that 42% of patients say they have been misdiagnosed, and each patient with a rare disease needs to go through an average of eight doctors in seven years to see a corresponding rare disease specialist. More importantly, most rare diseases seriously affect the health and quality of life of patients. The ocular surface malignant tumor is a typical rare disease, and its incidence is less than 1 / 100000. The ocular surface not only affects the patient's appearance, but also damages the visual function, and the malignant tumor may even affect life. These uncommon malignant tumors are often hidden in the common black nevus on the eye surface, which is easy to be ignored and has great potential risks. With the improvement of people's living standards, people start to pay attention to rare diseases.

In recent years, the rapid development of digital technology has also provided new opportunities for the prevention and treatment of rare diseases. Our team established the database of rare ophthalmopathy in China in the early stage, which provided a solid foundation for the digitization of precious clinical data. This study intends to develop an intelligent screening system for ocular surface malignant tumors, using the mobile phone for real-world verification and scale screening, and explore it to improve the ability of doctors to diagnose and treat rare diseases. This study is expected to improve the ability to screen malignant tumors on the ocular surface and provide a novel model for the universal screening of rare diseases.


Eligibility criteria: Inclusion Criteria:

* Dark-brown lesions on the ocular surface are found: i.e. ocular surface malignant melanoma, ocular basal cell carcinoma, conjunctival nevus, eyelid nevus, sclera pigmentation, benign eyelid keratosis

Exclusion Criteria:

* Non-pigmented ocular surface tumors: pterygium, corneal dermoid tumor, meibomian gland cyst, cataract, blepharitis, etc.
* The image quality does not meet the clinical requirements.

Primary outcomes:
measure: Area under the curve (AUC)
timeFrame: 2024.1
Secondary outcomes:
measure: Sensitivity, specificity and accuracy
timeFrame: 2024.1
measure: Screening coverage
timeFrame: 2024.1
measure: Referral efficiency
timeFrame: 2024.1
measure: Human-machine collaboration performance
timeFrame: 2024.1
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhognshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
References: