- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04255667
Eyelid Crush for Marginal Eyelid Surgery
January 26, 2021 updated by: Tarek Roshdy mohamed Mahgoub ELhamaky, Benha University
Outcome of Eyelid Crush for Intraoperative Hemostasis of Eyelid Margin Surgery
Surgery involves eyelid margin asscocited with intraoperative bleeding.
Proper intra-operative homeostasis is essential for good intraoperative procedure and postoperative results.
Study Overview
Detailed Description
baseline and postoperative full ophthalmic examination was done.Procedure include all surgeries involving eyelid margin
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: TAREK R ELHAMAKY
Study Locations
-
-
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Abu Dhabi, United Arab Emirates, 46266
- Recruiting
- INMC
-
-
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 to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
60 patient with marginal eyelid diseases surgeries will undergo surgeries
Description
Inclusion Criteria:
- All surgeries involving eyelid margin
Exclusion Criteria:
- bleeding tendency
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 |
---|---|
Study group
Eyelid surgery involving eyelid margin is done after eyelid margin crushing with hemostat at start of surgery
|
after marking eyelid , hemostat is used for eyelid margin incision crush .
Then eyelid surgery is done
|
Control group
Eyelid surgery involving eyelid margin is done after eyelid margin crushing without hemostat
|
after marking eyelid , hemostat is used for eyelid margin incision crush .
Then eyelid surgery is done
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
amount of intraoperative bleeding
Time Frame: intraoperative
|
bleeding is recorded by photography
|
intraoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
time of operation
Time Frame: intraoperative
|
time of surgery is recorded by stopwatch
|
intraoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: TAREK R ELHAMAKY, 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)
April 1, 2021
Study Completion (Anticipated)
April 15, 2021
Study Registration Dates
First Submitted
February 3, 2020
First Submitted That Met QC Criteria
February 3, 2020
First Posted (Actual)
February 5, 2020
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
- hamaky4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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