Eyelid DiseasesNCT04201925
Functional Changes After Upper Blepharoplasty
An observational study of Eyelid Diseases, run by Benha University at 1 site in United Arab Emirates.
Trial summary
Upper blepharoplasty is a common eyelid procedure. It associated with visual, cosmetic and functional changes .Investigator will evaluate outcome of this procedure. 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?
- upper blepharoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Jan 2019to 30 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 50 patient with upper eyelid Dermatochalasis and will undergo upper blepharoblasty procedure.
Who may be able to join
- upper eyelid Dermatochalasis
Who cannot join
- Eyelid diseases
- previous eyelid surgery
Trial locations and contacts
1 site in 1 country.
TAREK ELHAMAKY contact
United Arab Emirates1 site, 1 recruiting
- Recruiting
INMC
Abu Dhabi, 46266
TAREK ELHAMAKY, MD
About this study
Official title: Objective and Subjective Functional Outcomes Following Upper Blepharoplasty
Upper blepharoplasty is a common eyelid procedure. It associated with visual, cosmetic and functional changes .Investigator will evaluate outcome of this procedure.
Read the detailed description
baseline and postoperative 1,3,6 and 12 months full ophthalmic examination was done.
Procedure is upper blepharoplasty.
- Conditions
- Eyelid Diseases
- Being tested
- upper blepharoplasty
- Keywords
- blepharoplasty, visual field
- 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 blepharoplastyProcedure or surgery
excision of excess eyelid skin with or without strip of orbicularis muscle ; with or without upper orbital fat
| Study group | Role | What they receive |
|---|---|---|
| blepharoplasty | Patients will undergo blepharoplasty surgery Receives: Procedure: upper blepharoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual field changes
Post operative visual field changes in form of change in visual field sensitivity decibel (dB)using Humphrey Field Analyzer( HFA) II-i (Carl Zeiss Meditec ,Jena, Germany)
Measured: 6 months
Secondary outcomes (1)
corneal topographic changes
Postoperative topographic changes of the cornea in form of central keratoconus index using Pentacam HR (Oculus GmbH, Wetzlar, Germany).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start1 Jan 2019
- Primary completion1 Jun 2021 (estimated)
- Study completion30 Jun 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.
- 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 R ELAHAMKY, MD, Principal investigator, Benha university faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201925
- Sponsor's protocol ID
- hamaky3
- Status last verified
- Jan 2021
- First submitted
- 24 Nov 2019
- Last updated
- 27 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 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective and Subjective Functional Outcomes Following Upper Blepharoplasty
- ClinicalTrials.gov ID
- NCT04201925
- Acronym / sponsor ID
- hamaky3
- Conditions
- Eyelid Diseases
- Keywords
- blepharoplasty, visual field
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 17 Dec 2019 (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.
Upper blepharoplasty is a common eyelid procedure. It associated with visual, cosmetic and functional changes .Investigator will evaluate outcome of this procedure.
Detailed description
baseline and postoperative 1,3,6 and 12 months full ophthalmic examination was done.
Procedure is upper blepharoplasty.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| blepharoplasty | – | Procedure: upper blepharoplastyPatients will undergo blepharoplasty surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 50 patient with upper eyelid Dermatochalasis and will undergo upper blepharoblasty procedure.
Key inclusion criteria (1 listed)
- upper eyelid Dermatochalasis
Key exclusion criteria (2 listed)
- Eyelid diseases
- 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 blepharoplastyexcision of excess eyelid skin with or without strip of orbicularis muscle ; with or without upper orbital fat | Procedure or surgery | blepharoplasty |
Primary outcome
visual field changes
Time frame: 6 months
Post operative visual field changes in form of change in visual field sensitivity decibel (dB)using Humphrey Field Analyzer( HFA) II-i (Carl Zeiss Meditec ,Jena, Germany)
1 secondary outcome
corneal topographic changes
Time frame: 6 months
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.
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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 ELHAMAKY contact
TAREK R ELAHAMKY, 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 2 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?
visual field changes (time frame: 6 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 27 Jan 2021.