Eyelid DiseasesNCT04861454
Brassiere Brow Suture and Internal Browpexy
An observational study of Eyelid Diseases, run by Benha University at 1 site in United Arab Emirates.
Trial summary
Brow ptosis is a common problem. internal browbexy and brassier suture are common surgical approach Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eyelid Diseases
- How many people
- 30 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 10 Jan 2021to 20 Jul 2024
- 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 with dermatochalasis
Who may be able to join
- brow ptosis and dermatochalasis
Who cannot join
- eyelid diseases and previous surgery
Trial locations and contacts
1 site in 1 country.
TAREK ELHAMAKY contact
United Arab Emirates1 site, 1 recruiting
- Recruiting
INMC
Abu Dhabi, 46266
About this study
Official title: Brassiere Brow Suture and Internal Browpexy as Disjunctive Upper Eyelid Blepharoplasty
Brow ptosis is a common problem. internal browbexy and brassier suture are common surgical approach
Read the detailed description
upper eye transcutaneous blepharoplasty then combined browbexy and brassier suture are done
- Conditions
- Eyelid Diseases
- Keywords
- blepharoplasty, browbexy
- Medical subject headings
- Eyelid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| surgical | internal browbexy and brassier suture were done after blepharoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
global aesthetic scale
calculate scale score from score 1 exceptional improvement to 5 worsening 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 posted27 Apr 2021
- Study start10 Jan 2021
- Primary completion10 Jul 2024 (estimated)
- Study completion20 Jul 2024 (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
- 30 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 elhamaky, MD, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861454
- Sponsor's protocol ID
- Hamaky10
- Status last verified
- Nov 2023
- First submitted
- 19 Apr 2021
- Last updated
- 18 Nov 2023
- 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brassiere Brow Suture and Internal Browpexy as Disjunctive Upper Eyelid Blepharoplasty
- ClinicalTrials.gov ID
- NCT04861454
- Acronym / sponsor ID
- Hamaky10
- Conditions
- Eyelid Diseases
- Keywords
- blepharoplasty, browbexy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 10 Jul 2024 (estimated)
- Study completion
- 20 Jul 2024 (estimated)
- First posted
- 27 Apr 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.
Brow ptosis is a common problem. internal browbexy and brassier suture are common surgical approach
Detailed description
upper eye transcutaneous blepharoplasty then combined browbexy and brassier suture are done
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surgical | – | –internal browbexy and brassier suture were done after blepharoplasty |
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 with dermatochalasis
Key inclusion criteria (1 listed)
- brow ptosis and dermatochalasis
Key exclusion criteria (1 listed)
- eyelid diseases and previous surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
global aesthetic scale
Time frame: 1 year
calculate scale score from score 1 exceptional improvement to 5 worsening patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
Related trials for Eyelid Diseases
Active, not recruiting
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
Meibomian Gland Dysfunction, Dry Eye Disease
RecruitingObservational study
Blepharoptosis After Repeated Intravitreal Anti-VEGF Injections: A Prospective Study
Blepharoptosis, Age-Related Macular Degeneration
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 ELHAMAKY contact
tarek elhamaky, MD principal investigator
Benha University
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 18 Nov 2023. 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 (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 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 18 Nov 2023.