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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02893813
Other study ID # 2015-10Obs-CHRMT
Secondary ID
Status Completed
Phase N/A
First received August 30, 2016
Last updated September 14, 2016
Start date November 2015
Est. completion date April 2016

Study information

Verified date August 2016
Source Centre Hospitalier Régional Metz-Thionville
Contact n/a
Is FDA regulated No
Health authority France: Commission nationale de l'informatique et des libertés
Study type Observational

Clinical Trial Summary

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


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)


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date April 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients underwent eyelid ectropion surgery

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Régional Metz-Thionville

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of life related to discomfort due to watering after eyelid ectropion surgery questionnaire quality of life 1 year No
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