A Prospective Study: Artificial Intelligence-assisted Screening of Malignant Pigmented Tumors on the Ocular Surface

Sponsor
Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05645341
Collaborator
(none)
400
1
36
11.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: screening system for ocular surface malignant tumors

Study Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective Study: Artificial Intelligence-assisted Screening of Malignant Pigmented Tumors on the Ocular Surface
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Eligible participants for smartphone-based ocular surface tumors diagnosis

Diagnostic Test: screening system for ocular surface malignant tumors
Develop an intelligent screening system for ocular surface malignant tumors, apply it to the mobile terminal for real-world verification and large-scale general screening, and test its effect on assisting doctors in the diagnosis and treatment of rare diseases.

Outcome Measures

Primary Outcome Measures

  1. Screening coverage [2024.1]

    Count the number of people who have successfully received and read knowledge about ocular surface pigmented tumors on each offline and online platform.

  2. Accuracy [2024.1]

    Use the intelligent screening system to diagnose the pictures collected by all subjects, and count the proportion of correct pictures in all pictures.

  3. Referral efficiency [2024.1]

    For cases where the system judges that it is necessary to go to the hospital for further diagnosis and treatment, two or more researchers will conduct a diagnostic review first. If further diagnosis and treatment is really needed, the subject will be contacted and told to go to the hospital for treatment by phone, text message, etc., and continue to follow up. Finally, the duration of diagnosis (screening time to pathological diagnosis time), visit distance, number of visits before diagnosis, and the proportion of referred patients in all subjects were counted.

  4. Human-machine collaboration performance [2024.1]

    Doctors with different seniority were asked to diagnose the test set with and without assistance from the intelligent screening system, and the accuracy rates in the two cases were calculated and compared.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

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

Exclusion Criteria:
  1. Non-pigmented ocular surface tumors: pterygium, corneal dermoid tumor, meibomian gland cyst, cataract, blepharitis, etc.

  2. The image quality does not meet the clinical requirements. -

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhognshan Ophthalmic Center, Sun Yat-sen University Guangzhou Guangdong China 510060

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Haotian Lin, Clinical Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT05645341
Other Study ID Numbers:
  • 2022KYPJ067
First Posted:
Dec 9, 2022
Last Update Posted:
Dec 9, 2022
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Haotian Lin, Clinical Professor, Sun Yat-sen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 9, 2022