- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02893813
Comparison Between Two Surgical Methods for Eyelid Ectropion: Tarsal Strip Alone Versus Tarsal Strip With Punctoplasty (Three Snips With or Without Diamond-shaped Resection) (ECTROPALP)
September 14, 2016 updated by: Centre Hospitalier Régional Metz-Thionville
Ectropion of the eyelid can lead to skin retraction, stenosis of lacrimal point, chronic watering, visual discomfort or low visual acuity, mostly when it occurs with ectropion of lacrimal point.
The objective of the study is to compare two surgical strategies for eyelid ectropion combined with ectropion of the lacrimal point
Study Overview
Status
Completed
Conditions
Detailed Description
Were included patients underwent eyelid ectropion surgery in ophthalmology department from Oct 2014 to Oct 2015.
The first procedure is lateral tarsal strip alone (group 1); the second one is lateral tarsal strip with three snips with or without diamond-shaped resection (group 2).
The authors focused on the alteration of the quality of life related to watering, before and after operation.
Quality of life related to discomfort due to watering was evaluated before and after surgery using a questionnaire.
Informations have been gathered via phone with a ten items questionnaire, each item is worth 0 (no or minim discomfort due to watering) or 1 (discomfort due to more than moderated watering)
Study Type
Observational
Enrollment (Actual)
22
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients underwent eyelid ectropion surgery
Description
Inclusion Criteria:
- patients underwent eyelid ectropion surgery
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life related to discomfort due to watering after eyelid ectropion surgery
Time Frame: 1 year
|
questionnaire quality of life
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2015
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
August 30, 2016
First Submitted That Met QC Criteria
September 8, 2016
First Posted (Estimate)
September 9, 2016
Study Record Updates
Last Update Posted (Estimate)
September 15, 2016
Last Update Submitted That Met QC Criteria
September 14, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-10Obs-CHRMT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ectropion
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University Hospital OstravaRecruitingEyelid Ptoses | Ectropion Eyelids | Entropion;EyeCzechia
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University of California, Los AngelesWithdrawn
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The Cleveland ClinicCompletedEpiphora | Ectropion | Nasolacrimal Duct Obstruction | Canalicular Stenosis | Functional Tear Pump FailureUnited States
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University of LouisvilleWithdrawnPtosis, Eyelid | Entropion | Ectropion | Dermatochalasis of EyelidUnited States