PtosisNCT07534436
A Prospective Cohort Study on Visual Function and Psychological Conditions Before and After Surgery for Congenital Ptosis
An observational study of Ptosis, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Ptosis
- How many people
- 73 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 30 Sep 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, 510000
About this study
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?
Read more
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
- Medical subject headings
- Blepharoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ptosis group | Not described | |
| control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
stereoacuity
Measured: From enrollment to 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 Jun 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PtosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534436
- Sponsor's protocol ID
- 2025KYPJ084
- Status last verified
- Jan 2026
- First submitted
- 9 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study on Visual Function and Psychological Conditions Before and After Surgery for Congenital Ptosis
- ClinicalTrials.gov ID
- NCT07534436
- Acronym / sponsor ID
- 2025KYPJ084
- Conditions
- Ptosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ptosis group | – | – |
| control group | – | – |
Who may qualify
- Ages
- 3 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
stereoacuity
Time frame: From enrollment to 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ptosis, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ronxin Chen (15989045884, rongxinchan@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stereoacuity (time frame: From enrollment to 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026; AzTrials last refreshed its copy on 29 Oct 2026.