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Congenital Ptosis Surgery Visual Function and Psychological Conditions Prospective Cohort Study

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Summary

NIH ClinicalTrials.gov registered NCT07534436, an observational prospective cohort study evaluating 6-month outcomes of Levator Resection combined with Fascial Sheath Suspension surgery in patients with congenital ptosis. The study will assess improvements in best-corrected visual acuity, stereopsis, and patient-reported quality of life through standardized ophthalmological examinations at baseline and 1, 3, and 6 months post-operation. Enrollment includes patients already scheduled for this combined surgical procedure as part of their regular medical care.

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What changed

This document registers a new observational clinical study (NCT07534436) on ClinicalTrials.gov, the NIH-maintained clinical research registry. The study will follow patients undergoing combined Levator Resection and Fascial Sheath Suspension surgery for congenital ptosis, measuring visual acuity, stereopsis, and quality of life outcomes over 6 months.

For compliance purposes, this registry entry has no immediate regulatory impact. Clinical investigators and healthcare providers conducting similar studies or treating congenital ptosis patients may find this registry useful for understanding current research landscape. The study does not impose compliance obligations, reporting requirements, or deadlines on regulated entities.

Archived snapshot

Apr 16, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

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

Observational NCT07534436 Kind: OBSERVATIONAL Apr 16, 2026

Abstract

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

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Last updated

Classification

Agency
NIH
Published
April 16th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07534436

Who this affects

Applies to
Clinical investigators Healthcare providers
Industry sector
6221 Hospitals & Health Systems
Activity scope
Clinical trial registration Surgical outcomes research
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Medical Devices Public Health

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