Visual function and emotional well-being before and after congenital ptosis surgery

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

This project will try to see if combining levator resection with fascial sheath suspension improves vision and quality of life over six months for people aged 3–60 having surgery for congenital ptosis.

Quick facts

• Study type: Observational
• Enrollment: 73 (estimated)
• Ages: 3 Years to 60 Years
• Sex: All
• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07534436 on ClinicalTrials.gov

What this trial studies

This single-center prospective observational cohort enrolls patients aged 3–60 who are already scheduled for combined levator resection and fascial sheath suspension for congenital ptosis at Zhongshan Ophthalmic Center. Participants undergo standardized ophthalmological exams measuring best-corrected visual acuity, stereopsis, and other visual function indicators, plus a patient-reported quality-of-life questionnaire before surgery and at 1, 3, and 6 months after surgery. There is no randomization or experimental intervention beyond standard clinical care; the study documents changes over time. The aim is to characterize short-term functional and psychological outcomes following this combined surgical approach.

Who should consider this trial

Good fit: Ideal candidates are people aged 3–60 with unilateral or bilateral congenital ptosis who are already scheduled for levator resection plus fascial sheath suspension and can provide informed consent (or have parental consent).

Not a fit: Patients outside the 3–60 age range, those with non-congenital ptosis or significant other ocular comorbidities, or those unable to attend required follow-up visits are unlikely to benefit from this study's findings.

Why it matters

Potential benefit: If successful, the combined surgery could improve best-corrected visual acuity, stereopsis, and patient-reported quality of life within six months after the operation.

How similar studies have performed: Established eyelid procedures like levator resection and fascial sheath techniques have shown improvements in eyelid position and function, but there is limited published data specifically on the combined procedure's short-term effects on vision and quality of life.

Eligibility criteria

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:

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Where this trial is running

Guangzhou, Guangdong

• Zhongshan Ophthalmic Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Ronxin Chen

Conditions Ptosis