Patients With Cicatricial EctropionNCT06344689
Surgical Correction of Cicatricial Ectropion
An observational study of Patients With Cicatricial Ectropion and Over 18-year-old, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
The main purpose of this study is to verify and compare the treatment effects of scarred ectropion surgery, perform statistical descriptions, compare patients undergoing tarsal strip and skin flap procedures with those undergoing simple skin flap treatment, and compare their pre- and post-operative Ectropion Grading… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Cicatricial Ectropion, Over 18-year-old, With Complete Clinical Record
- What is being tested?
- Surgical treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2023to 27 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ectropion underwent surgical treatment in our center.
Who may be able to join
- patients with Cicatricial Ectropion;
- over 18-year-old;
- with complete clinical record.
Who cannot join
- patients with severe complications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Surgical Correction of Cicatricial Ectropion: a Retrospective Study
The main purpose of this study is to verify and compare the treatment effects of scarred ectropion surgery, perform statistical descriptions, compare patients undergoing tarsal strip and skin flap procedures with those undergoing simple skin flap treatment, and compare their pre- and post-operative Ectropion Grading Scale (EGS) and subjective and objective symptom changes.
Secondary Objective: To observe the incidence and resolution of complications after lower eyelid ectropion surgery. Compare postoperative effects among patients of different ages undergoing the same surgery.
- Being tested
- Surgical treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical treatmentOther
Patients underwent surgical treatment of ectropion were included in this study.
| Study group | Role | What they receive |
|---|---|---|
| Patients with ectropion underwent surgical treatment. | Not described Receives: Other: Surgical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ectropion Grading Scale
The EGS describes the severity of the ectropion, with higher score for more severe ectropion.
Measured: preoperative and one-year posttreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start12 Dec 2023
- Primary completion28 Feb 2024
- Study completion27 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Cicatricial EctropionStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Lu, PhD., Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344689
- Sponsor's protocol ID
- SH9H-2023-T477
- Status last verified
- Apr 2024
- First submitted
- 27 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Surgical Correction of Cicatricial Ectropion: a Retrospective Study
- ClinicalTrials.gov ID
- NCT06344689
- Acronym / sponsor ID
- SH9H-2023-T477
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 27 Mar 2024 (actual)
- First posted
- 3 Apr 2024 (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 main purpose of this study is to verify and compare the treatment effects of scarred ectropion surgery, perform statistical descriptions, compare patients undergoing tarsal strip and skin flap procedures with those undergoing simple skin flap treatment, and compare their pre- and post-operative Ectropion Grading Scale (EGS) and subjective and objective symptom changes.
Secondary Objective: To observe the incidence and resolution of complications after lower eyelid ectropion surgery. Compare postoperative effects among patients of different ages undergoing the same surgery.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ectropion underwent surgical treatment. | – | Other: Surgical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ectropion underwent surgical treatment in our center.
Key inclusion criteria (3 listed)
- patients with Cicatricial Ectropion;
- over 18-year-old;
- with complete clinical record.
Key exclusion criteria (1 listed)
- patients with severe complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical treatmentPatients underwent surgical treatment of ectropion were included in this study. | Other | Patients with ectropion underwent surgical treatment. |
Primary outcome
Ectropion Grading Scale
Time frame: preoperative and one-year posttreatment
The EGS describes the severity of the ectropion, with higher score for more severe ectropion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: Undecided
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Patients With Cicatricial Ectropion and Over 18-year-old, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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: finished, as of the sponsor's last update on 3 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ectropion Grading Scale (time frame: preoperative and one-year posttreatment). 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 3 Apr 2024.