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Completed

NCT Number: NCT07078552

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

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.

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Key information

Conditions

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Hangzhou, Zhejiang, 310009, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ptosis

Other

no intervention

Primary outcomes

  1. levator function testing

    Time frame: One-time assessment; results available within 1 week of data collection.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • Shanghai Jiao Tong University School of Medicine
  • Tianjin Eye Hospital

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2025
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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