Eyelid DiseasesNCT04255667
Eyelid Crush for Marginal Eyelid Surgery
An observational study of Eyelid Diseases, run by Benha University at 1 site in United Arab Emirates.
Trial summary
Surgery involves eyelid margin asscocited with intraoperative bleeding. Proper intra-operative homeostasis is essential for good intraoperative procedure and postoperative results. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Eyelid Diseases
- What is being tested?
- Eyelid margin crush
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Jan 2019to 15 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 60 patient with marginal eyelid diseases surgeries will undergo surgeries
Who may be able to join
- All surgeries involving eyelid margin
Who cannot join
- bleeding tendency
Trial locations and contacts
1 site in 1 country.
TAREK R ELHAMAKY contact
United Arab Emirates1 site, 1 recruiting
- Recruiting
INMC
Abu Dhabi, 46266
TAREK ELHAMAKY, MD
About this study
Official title: 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.
Read the detailed description
baseline and postoperative full ophthalmic examination was done.Procedure include all surgeries involving eyelid margin
- Conditions
- Eyelid Diseases
- Being tested
- Eyelid margin crush
- Keywords
- eyelid margin, hemostasis
- Medical subject headings
- Eyelid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eyelid margin crushProcedure or surgery
after marking eyelid , hemostat is used for eyelid margin incision crush . Then eyelid surgery is done
| Study group | Role | What they receive |
|---|---|---|
| Study group | Eyelid surgery involving eyelid margin is done after eyelid margin crushing with hemostat at start of surgery Receives: Procedure: Eyelid margin crush | |
| Control group | Eyelid surgery involving eyelid margin is done after eyelid margin crushing without hemostat Receives: Procedure: Eyelid margin crush |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of intraoperative bleeding
bleeding is recorded by photography
Measured: intraoperative
Secondary outcomes (1)
time of operation
time of surgery is recorded by stopwatch
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Jan 2019
- Primary completion1 Apr 2021 (estimated)
- Study completion15 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eyelid DiseasesStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Roshdy mohamed Mahgoub ELhamaky, Benha University
- Investigators
- TAREK R ELHAMAKY, MD, Principal investigator, Benha university faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255667
- Sponsor's protocol ID
- hamaky4
- Status last verified
- Jan 2021
- First submitted
- 3 Feb 2020
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Eyelid Crush for Intraoperative Hemostasis of Eyelid Margin Surgery
- ClinicalTrials.gov ID
- NCT04255667
- Acronym / sponsor ID
- hamaky4
- Conditions
- Eyelid Diseases
- Keywords
- eyelid margin, hemostasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 15 Apr 2021 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Surgery involves eyelid margin asscocited with intraoperative bleeding. Proper intra-operative homeostasis is essential for good intraoperative procedure and postoperative results.
Detailed description
baseline and postoperative full ophthalmic examination was done.Procedure include all surgeries involving eyelid margin
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Procedure: Eyelid margin crushEyelid surgery involving eyelid margin is done after eyelid margin crushing with hemostat at start of surgery |
| Control group | – | Procedure: Eyelid margin crushEyelid surgery involving eyelid margin is done after eyelid margin crushing without hemostat |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 60 patient with marginal eyelid diseases surgeries will undergo surgeries
Key inclusion criteria (1 listed)
- All surgeries involving eyelid margin
Key exclusion criteria (1 listed)
- bleeding tendency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eyelid margin crushafter marking eyelid , hemostat is used for eyelid margin incision crush . Then eyelid surgery is done | Procedure or surgery | Control group, Study group |
Primary outcome
amount of intraoperative bleeding
Time frame: intraoperative
bleeding is recorded by photography
1 secondary outcome
time of operation
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TAREK R ELHAMAKY contact
TAREK R ELHAMAKY, MD principal investigator
Benha university faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eyelid Diseases, run by Benha University at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact TAREK R ELHAMAKY, MD (+971503207889, dr_thamakyy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amount of intraoperative bleeding (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021; AzTrials last refreshed its copy on 2 Nov 2026.