Functional Changes After Upper Blepharoplasty

January 26, 2021 updated by: Tarek Roshdy mohamed Mahgoub ELhamaky, Benha University

Objective and Subjective Functional Outcomes Following Upper Blepharoplasty

Upper blepharoplasty is a common eyelid procedure. It associated with visual, cosmetic and functional changes .Investigator will evaluate outcome of this procedure.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

baseline and postoperative 1,3,6 and 12 months full ophthalmic examination was done.

Procedure is upper blepharoplasty.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Probability Sample

Study Population

50 patient with upper eyelid Dermatochalasis and will undergo upper blepharoblasty procedure.

Description

Inclusion Criteria:

• upper eyelid Dermatochalasis

Exclusion Criteria:

  • Eyelid diseases
  • previous eyelid surgery

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
blepharoplasty
Patients will undergo blepharoplasty surgery
Procedure: upper blepharoplasty
excision of excess eyelid skin with or without strip of orbicularis muscle ; with or without upper orbital fat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual field changes
Time Frame: 6 months
Post operative visual field changes in form of change in visual field sensitivity decibel (dB)using Humphrey Field Analyzer( HFA) II-i (Carl Zeiss Meditec ,Jena, Germany)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
corneal topographic changes
Time Frame: 6 months
Postoperative topographic changes of the cornea in form of central keratoconus index using Pentacam HR (Oculus GmbH, Wetzlar, Germany).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Investigators

  • Principal Investigator: TAREK R ELAHAMKY, MD, Benha university faculty of medicine

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 (Actual)

January 1, 2019

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

June 30, 2021

Study Registration Dates

First Submitted

November 24, 2019

First Submitted That Met QC Criteria

December 15, 2019

First Posted (Actual)

December 17, 2019

Study Record Updates

Last Update Posted (Actual)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hamaky3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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