Surgical Correction of Cicatricial Ectropion | NCT06344689

Studies
Surgical Correction of Cicatricial Ectropion

NCT06344689

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Status

Completed

Last Update Posted

Apr 3, 2024Actual

Enrollment

26Actual

Phase

Not provided

Conditions

Patients With Cicatricial Ectropion
Over 18-year-old
With Complete Clinical Record

Interventions

Surgical treatment

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 12, 2023Actual

Primary Completion Date

Feb 28, 2024Actual

Completion Date

Mar 27, 2024Actual

First Submitted Date

Mar 27, 2024

First Submission Date that Met QC Criteria

Apr 2, 2024

First Posted Date

Apr 3, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2024

Last Update Posted Date

Apr 3, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lin Lu, PhD., Doctor, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityPrincipal Investigator

Lead Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with ectropion underwent surgical treatment.			Other: Surgical treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgical treatment	Other	Patients underwent surgical treatment of ectropion were included in this study.	Patients with ectropion underwent surgical treatment.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ectropion Grading Scale	The EGS describes the severity of the ectropion, with higher score for more severe ectropion.	preoperative and one-year posttreatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with Cicatricial Ectropion;
over 18-year-old;
with complete clinical record.

Exclusion Criteria:

patients with severe complications

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with ectropion underwent surgical treatment in our center.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai ninth people's hospital		Shanghai		200011	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided