NCT07078552

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
368

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
Last Updated

July 22, 2025

Status Verified

June 1, 2025

Enrollment Period

1.3 years

First QC Date

July 13, 2025

Last Update Submit

July 13, 2025

Conditions

Congenital Ptosis

Keywords

Congenital Ptosislevator function

Outcome Measures

Primary Outcomes (1)

  • levator function testing

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

Study Arms (1)

congenital ptosis

Other: ptosis

Interventions

ptosisOTHER

no intervention

congenital ptosis

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Inclusion criteria required 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. Healthy controls exhibited age-appropriate ocular development without eyelid abnormalities.

You may qualify if:

  • 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

You may not qualify if:

  • acquired ptosis, myasthenia gravis, Marcus Gunn syndrome, eyelid deformities, or prior ophthalmic surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Interventions

BPESC1 lncRNA, human

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2025

First Posted

July 22, 2025

Study Start

January 1, 2024

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

July 22, 2025

Record last verified: 2025-06

Locations

CN(1)