A Prospective Cohort Study on Visual Function and Psychological Conditions Before and After Surgery for Congenital Ptosis

April 9, 2026 updated by: Zhongshan Ophthalmic Center, Sun Yat-sen University

The goal of this observational study is to learn about the 6-month effects of Levator Resection combined with Fascial Sheath Suspension surgery in patients who undergo this procedure to treat congenital ptosis. The main questions it aims to answer are:

Does this combined surgery improve best-corrected visual acuity, stereopsis, and other visual function indicators in patients with congenital ptosis within 6 months after the operation?

Does this surgery lead to an improvement in patient-reported quality of life during the same period?

Patients already scheduled to undergo this combined surgery as part of their regular medical care for congenital ptosis will complete a series of standardized ophthalmological examinations and a quality of life questionnaire before surgery and at 1, 3, and 6 months post-operation.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

73

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Zhongshan Ophthalmic Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The plan is to continuously enroll newly diagnosed or unoperated patients from the Ophthalmic Plastic Surgery Clinic of the Sun Yat-sen University Eye Center, and simultaneously invite accompanying individuals as a control group

Description

Inclusion Criteria:

  1. Unilateral or bilateral congenital ptosis, male or female;
  2. Age: 3-60 years old
  3. Informed consent, and voluntary signing of the informed consent form, in compliance with ethical norms

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
control group
ptosis group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
stereoacuity
Time Frame: From enrollment to 6 months after surgery
From enrollment to 6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025KYPJ084

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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