Research on Precision Diagnosis and Treatment Decision of Common Eye Diseases Based on Artificial Intelligence

NCT ID: NCT07078552

Last Updated: 2025-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

368 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-05-01

Brief Summary

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The goal of this observational study is to investigate the clinical features of congenital ptosis in children by analyzing eyelid movement captured through smartphone videos. The main question it aims to answer is:

Can video-based eyelid measurements and levator muscle function grading provide useful guidance for the treatment of congenital ptosis in children?

Participants are children diagnosed with congenital ptosis. Their blinking behavior will be recorded using a smartphone, and eyelid morphology and muscle strength will be assessed from the video data.

Detailed Description

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In this study, we developed a two-module system for the evaluation of congenital ptosis in children based on smartphone video recordings. The first module performs morphological measurements of eyelid parameters (e.g., palpebral fissure height, margin reflex distance) extracted from blink videos. The accuracy of this module was assessed through agreement analysis between automated measurements and manual measurements performed by clinicians.

The second module focuses on levator function grading. The automated grading results were compared against clinical assessments by senior oculoplastic specialists, which served as the gold standard, to evaluate the model's accuracy. Additionally, we compared the model's performance to that of junior ophthalmology residents to assess the system's clinical assistive value in real-world scenarios.

Based on these modules, we developed a smartphone-based application for remote ptosis assessment. A multi-center clinical validation study was designed to evaluate the feasibility, consistency, and generalizability of the system in different clinical settings.

Conditions

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Congenital Ptosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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congenital ptosis

ptosis

Intervention Type OTHER

no intervention

Interventions

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ptosis

no intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* participants aged ≤18 years with compliance during video recording. Congenital ptosis diagnosis mandated documented symptom onset within the first year of life and bilateral or unilateral MRD1 of \< 2.5 mm

Exclusion Criteria

* acquired ptosis, myasthenia gravis, Marcus Gunn syndrome, eyelid deformities, or prior ophthalmic surgery
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role collaborator

Tianjin Eye Hospital

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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2023-1035

Identifier Type: -

Identifier Source: org_study_id

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