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

NCT07534436 | Recruiting

• 1 other identifier: 2025KYPJ084
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ptosis

Outcome Measures

Primary Outcomes (1)

• stereoacuity

  From enrollment to 6 months after surgery

Study Arms (2)

ptosis group

control group

Eligibility Criteria

• Age: 3 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

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

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Blepharoptosis

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Central Study Contacts

Ronxin Chen

CONTACT

15989045884; rongxinchan@foxmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 16, 2026
• Study Start: June 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-01

Locations

CN (1)