Eyelid DiseasesNCT04689230
Small Incision Technique Versus Upper Blepharoplasty in Upper Eyelid Medial Pad Fat Removal
A study testing upper eyelid blepharoplasty in people with 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. Small incision surgery could be a time-efficient, minimally invasive and scar formation procedure . 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?
- upper eyelid blepharoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Oct 2020to 15 Nov 2021
- Phase
- Interventional
- 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
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.
Tarek Elahamky contact
United Arab Emirates1 site, 1 recruiting
- Recruiting
INMC
Abu Dhabi, 46266
TAREK R ELHAMAKY, MD
About this study
Official title: Comparison of the Efficacy Between Small Incision Technique and Upper Blepharoplasty in Treatment of Upper Eyelid Medial Pad Fat Bulge
Medial upper eyelid pad of fat bulge is a common problem. Small incision surgery could be a time-efficient, minimally invasive and scar formation procedure .
Read the detailed description
Traditional upper eyelid blepharoplasty: an entire length upper eyelid crease followed by proper dissection are applied . identification and removal of medial pad of fat.
Small Incision technique: 4 mm medial upper eyelid small incision followed by proper dissection to gain direct access to the medial fat pad removal
- Conditions
- Eyelid Diseases
- Being tested
- upper eyelid 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.
upper eyelid blepharoplastyProcedure or surgery
upper eyelid blepharoplasty
| Study group | Role | What they receive |
|---|---|---|
| upper eyelid blepharoplasty | Active comparator | traditional upper eyelid blepharoplasty : upper eyelid entire length incision followed by proper dissection medially to medial pad fat.
medial pad fat identification and excision. closure of the wound with subcuticular 6/0 vicryl suture Receives: Procedure: upper eyelid blepharoplasty |
| small incision technique | Experimental | medial upper eyelid 4 mm length incision followed by proper dissection medially to medial pad fat.
medial pad fat identification and excision. closure of the wound with interrupted 6/0 vicryl sutures Receives: Procedure: upper eyelid 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: 3 months
Secondary outcomes (1)
duration of surgery
time of surgery in minutes measured by stopwatch
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start1 Oct 2020
- Primary completion1 Nov 2021 (estimated)
- Study completion15 Nov 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 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, M.D., Principal investigator, Benha university faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689230
- Sponsor's protocol ID
- Hamaky 8
- Status last verified
- Jan 2021
- First submitted
- 28 Dec 2020
- Last updated
- 22 Jan 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 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy Between Small Incision Technique and Upper Blepharoplasty in Treatment of Upper Eyelid Medial Pad Fat Bulge
- ClinicalTrials.gov ID
- NCT04689230
- Acronym / sponsor ID
- Hamaky 8
- Conditions
- Eyelid Diseases
- Keywords
- upper eyelid pad fat, blepharoplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 15 Nov 2021 (estimated)
- First posted
- 30 Dec 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.
Medial upper eyelid pad of fat bulge is a common problem. Small incision surgery could be a time-efficient, minimally invasive and scar formation procedure .
Detailed description
Traditional upper eyelid blepharoplasty: an entire length upper eyelid crease followed by proper dissection are applied . identification and removal of medial pad of fat.
Small Incision technique: 4 mm medial upper eyelid small incision followed by proper dissection to gain direct access to the medial fat pad removal
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| upper eyelid blepharoplasty | Active comparator | Procedure: upper eyelid blepharoplastytraditional upper eyelid blepharoplasty : upper eyelid entire length incision followed by proper dissection medially to medial pad fat. medial pad fat identification and excision. closure of the wound with subcuticular 6/0 vicryl suture |
| small incision technique | Experimental | Procedure: upper eyelid blepharoplastymedial upper eyelid 4 mm length incision followed by proper dissection medially to medial pad fat. medial pad fat identification and excision. closure of the wound with interrupted 6/0 vicryl sutures |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| upper eyelid blepharoplastyupper eyelid blepharoplasty | Procedure or surgery | small incision technique, upper eyelid blepharoplasty |
Primary outcome
global aesthetic improvement scale
Time frame: 3 months
calculate scale score (1-5);score 1:exceptional improvement and score 5 :worsened patient
1 secondary outcome
duration of surgery
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
Related trials for Eyelid Diseases
RecruitingObservational study
Blepharoptosis After Repeated Intravitreal Anti-VEGF Injections: A Prospective Study
Blepharoptosis, Age-Related Macular Degeneration
Active, not recruiting
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
Meibomian Gland Dysfunction, Dry Eye Disease
Not yet recruitingPhase 2
Omega-3 Supplementation vs Demodex vs Eyelid Cleanser for Pediatric Chalazia
Pediatric Chalazia
Not yet recruitingPhase 2
A Phase 2 Study to Compare Efficacy and Safety of a Novel Topical Therapy (APT-001, Spinosad 1.8%) in Patients With Blepharitis
Blepharitis
Not yet recruiting
TearCare in Young Adults
Meibomian Gland Dysfunction (Disorder)
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 contact
Tarek Elahamky, M.D. 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?
A study testing upper eyelid blepharoplasty in people with 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 22 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 Elahamky, M.D. (503207889 ext. +971, 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: 3 months). 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 22 Jan 2021.