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

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Zhejiang University

Status

Completed

Conditions

Congenital Ptosis

Treatments

Other: ptosis

Study type

Observational

Funder types

Other

Identifiers

NCT07078552
2023-1035

Details and patient eligibility

About

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.

Full description

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.

Enrollment

368 patients

Sex

All

Ages

Under 18 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

368 participants in 1 patient group

congenital ptosis
Treatment:
Other: ptosis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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