Eyelid DiseasesNCT04720586
Surgical Treatment of Lower Eyelid Involutional Entropion and Dermatochalasis
A study testing lower eyelid blepharoplasty , retractor plication and wedge resection and lower eyelid blepharoplasty and retractor plication in people with Eyelid Diseases, run by Benha University at 1 site in United Arab Emirates.
Trial summary
lower eyelid involutional entropion and dermatochalasis are common associated problems. combined approaches give good results. 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?
- lower eyelid blepharoplasty , retractor plication and wedge resection and lower eyelid blepharoplasty and retractor plication
- 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 Aug 2020to 31 Aug 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lower eyelid involutional entropion
- dermatochalasis
Who cannot join
- Other eyelid disease,
- Other causes of entropion
- 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: Lower Eyelid Retractors Plication , Transcutaneous Blepharoplasty and Wedge Resection for Treatment of Lower Eyelid Involutional Entropion and Dermatochalasis
lower eyelid involutional entropion and dermatochalasis are common associated problems. combined approaches give good results.
Read the detailed description
traditional lower eyelid transcutaneous blepharoplasty ; subciliary incision followed by proper dissection then lower eyelid retractors plication after orbital fat removal . pentagon wedge resection of lateral lower eyelid is done
- Conditions
- Eyelid Diseases
- Being tested
- lower eyelid blepharoplasty , retractor plication and wedge resection, lower eyelid blepharoplasty and retractor plication
- Keywords
- entropion, blepharoplasty
- Medical subject headings
- Eyelid Diseases, Entropion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lower eyelid blepharoplasty , retractor plication and wedge resectionProcedure or surgery
combined lower eyelid blepharoplasty , retractor plication and wedge resection
lower eyelid blepharoplasty and retractor plicationProcedure or surgery
combined lower eyelid blepharoplasty and retractor plication procedures
| Study group | Role | What they receive |
|---|---|---|
| triple procedure | Experimental | lower eyelid retractors plication , transcutaneous blepharoplasty and wedge resection Receives: Procedure: lower eyelid blepharoplasty , retractor plication and wedge resection; Procedure: lower eyelid blepharoplasty and retractor plication |
| combined procedure | Active comparator | lower eyelid retractors plication and transcutaneous blepharoplasty Receives: Procedure: lower eyelid blepharoplasty , retractor plication and wedge resection; Procedure: lower eyelid blepharoplasty and retractor plication |
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 is exceptional improvement , score 5 is worsened patient
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Aug 2020
- Primary completion1 Aug 2022 (estimated)
- Study completion31 Aug 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
- 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 R Elahamky, MD, Principal investigator, Benaha university faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720586
- Sponsor's protocol ID
- Hamaky9
- Status last verified
- Jan 2021
- First submitted
- 18 Jan 2021
- Last updated
- 28 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 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Eyelid Retractors Plication , Transcutaneous Blepharoplasty and Wedge Resection for Treatment of Lower Eyelid Involutional Entropion and Dermatochalasis
- ClinicalTrials.gov ID
- NCT04720586
- Acronym / sponsor ID
- Hamaky9
- Conditions
- Eyelid Diseases
- Keywords
- entropion, blepharoplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 22 Jan 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.
lower eyelid involutional entropion and dermatochalasis are common associated problems. combined approaches give good results.
Detailed description
traditional lower eyelid transcutaneous blepharoplasty ; subciliary incision followed by proper dissection then lower eyelid retractors plication after orbital fat removal . pentagon wedge resection of lateral lower eyelid is done
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| triple procedure | Experimental | Procedure: lower eyelid blepharoplasty , retractor plication and wedge resection, Procedure: lower eyelid blepharoplasty and retractor plicationlower eyelid retractors plication , transcutaneous blepharoplasty and wedge resection |
| combined procedure | Active comparator | Procedure: lower eyelid blepharoplasty , retractor plication and wedge resection, Procedure: lower eyelid blepharoplasty and retractor plicationlower eyelid retractors plication and transcutaneous blepharoplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Lower eyelid involutional entropion
- dermatochalasis
Key exclusion criteria (3 listed)
- Other eyelid disease,
- Other causes of entropion
- 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 |
|---|---|---|
| lower eyelid blepharoplasty , retractor plication and wedge resectioncombined lower eyelid blepharoplasty , retractor plication and wedge resection | Procedure or surgery | combined procedure, triple procedure |
| lower eyelid blepharoplasty and retractor plicationcombined lower eyelid blepharoplasty and retractor plication procedures | Procedure or surgery | combined procedure, triple procedure |
Primary outcome
Global Aesthetic Improvement Scale
Time frame: 12 months
calculate scale score (1-5); score 1 is exceptional improvement , score 5 is worsened patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 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 R Elahamky, MD principal investigator
Benaha 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 lower eyelid blepharoplasty , retractor plication and wedge resection and lower eyelid blepharoplasty and retractor plication 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 2 inclusion and 3 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 28 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?
Global Aesthetic Improvement Scale (time frame: 12 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 28 Jan 2021.