Eyelid DiseasesNCT05016362
Medial Fat Pad Preservation in Upper Eyelid Blepharoplasty
An observational study of Eyelid Diseases, run by Benha University at 1 site in United Arab Emirates.
Trial summary
Medial upper eyelid pad of fat bulge is a common problem. medial fat pad preservation might be a good adjutant to upper eyelid blepharoplasty Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eyelid Diseases
- What is being tested?
- medial fat preservation upper blepharoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 24 Dec 2020to Jun 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: at least 18 years old participant with dermtochlasis
Who may be able to join
- upper eyelid medial pad of fat bulge
Who cannot join
- Other eyelid diseases and previous eyelid surgery
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
INMC
Abu Dhabi, 46266
TAREK R ELHAMAKY, MD
About this study
Official title: Patient Satisfaction After Medial Fat Pad Preservation in Upper Eyelid Blepharoplasty
Medial upper eyelid pad of fat bulge is a common problem. medial fat pad preservation might be a good adjutant to upper eyelid blepharoplasty
Read the detailed description
Blepharoplasty with repositioning of the nasal fat pad to the central arcus marginalis of the superior orbital rim during surgery or orbitoglabellar groove
- Conditions
- Eyelid Diseases
- Being tested
- medial fat preservation upper blepharoplasty
- Keywords
- upper eyelid pad fat, blepharoplasty
- Medical subject headings
- Eyelid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medial fat preservation upper blepharoplastyProcedure or surgery
medial fat preservation upper blepharoplasty increasing volumetric upper eyelid skin fold
| Study group | Role | What they receive |
|---|---|---|
| Group A | blepharoplasty with repositioning of the nasal fat pad to the central arcus marginalis of the superior orbital rim during surgery. Receives: Procedure: medial fat preservation upper blepharoplasty | |
| Group B | blepharoplasty with repositioning of the nasal fat pad to orbitoglabellar groove during surgery. Receives: Procedure: medial fat preservation upper blepharoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
global aesthetic improvement scale
calculate scale score (1-5);score 1:exceptional improvement and score 5 :worsened patient
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start24 Dec 2020
- Primary completionMay 2022 (estimated)
- Study completionJun 2022 (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
- 50 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 Elahamky, Principal investigator, Benha university faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016362
- Sponsor's protocol ID
- Hamaky16
- Status last verified
- Aug 2021
- First submitted
- 17 Aug 2021
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction After Medial Fat Pad Preservation in Upper Eyelid Blepharoplasty
- ClinicalTrials.gov ID
- NCT05016362
- Acronym / sponsor ID
- Hamaky16
- Conditions
- Eyelid Diseases
- Keywords
- upper eyelid pad fat, blepharoplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 24 Dec 2020 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 23 Aug 2021 (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.
Medial upper eyelid pad of fat bulge is a common problem. medial fat pad preservation might be a good adjutant to upper eyelid blepharoplasty
Detailed description
Blepharoplasty with repositioning of the nasal fat pad to the central arcus marginalis of the superior orbital rim during surgery or orbitoglabellar groove
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Procedure: medial fat preservation upper blepharoplastyblepharoplasty with repositioning of the nasal fat pad to the central arcus marginalis of the superior orbital rim during surgery. |
| Group B | – | Procedure: medial fat preservation upper blepharoplastyblepharoplasty with repositioning of the nasal fat pad to orbitoglabellar groove during surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- at least 18 years old participant with dermtochlasis
Key inclusion criteria (1 listed)
- upper eyelid medial pad of fat bulge
Key exclusion criteria (1 listed)
- Other eyelid diseases and previous eyelid surgery
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 |
|---|---|---|
| medial fat preservation upper blepharoplastymedial fat preservation upper blepharoplasty increasing volumetric upper eyelid skin fold | Procedure or surgery | Group A, Group B |
Primary outcome
global aesthetic improvement scale
Time frame: 1 year
calculate scale score (1-5);score 1:exceptional improvement and score 5 :worsened patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
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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 Elahamky 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 23 Aug 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 Elahamky, M.D. (+971 503207889, dr_thamakyy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
global aesthetic improvement scale (time frame: 1 year). 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 23 Aug 2021.