Eyelid DiseasesNCT04538716
Retroseptal Transconjunctival Blepharoplasty for GIR
A study testing transconjunctival lower blepharoplasty in people with Eyelid Diseases, run by Benha University at 1 site in United Arab Emirates.
Trial summary
The tear trough deformity is a challenging cosmetic condition.surgical treatment and filling are good treatment options 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?
- transconjunctival lower 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 Aug 2019to 10 Nov 2023
- 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
- tear trough deformity
Who cannot join
- Eyelid diseases and previous eyelid surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Orbital Fat Graft Retroseptal Transconjunctival Blepharoplasty for Treatment of Groove in the Infraorbital Region
The tear trough deformity is a challenging cosmetic condition.surgical treatment and filling are good treatment options
Read the detailed description
Procedure is lower eyelid transconjunctival Blepharoplasty associated with stromal vascular fraction gel (SVF-gel) or fat transposition
- Conditions
- Eyelid Diseases
- Being tested
- transconjunctival lower blepharoplasty
- Keywords
- tear trough, blepharoplasty,orbital fat
- Medical subject headings
- Eyelid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transconjunctival lower blepharoplastyProcedure or surgery
transconjunctival lower blepharoplasty associated with stromal vascular fraction gel (SVF-gel)
| Study group | Role | What they receive |
|---|---|---|
| SVF-gel | Experimental | Transconjunctival blepharoplasty associated with associated with stromal vascular fraction gel (SVF-gel) Receives: Procedure: transconjunctival lower blepharoplasty |
| fat transposition | Experimental | Transconjunctival blepharoplasty associated with fat transposition Receives: Procedure: transconjunctival lower blepharoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
skin-periosteal depth
measure skin-periosteal depth
Measured: 2 years
Secondary outcomes (1)
global aesthetic improvement scale
calculate scale score from score 1 (exceptional improvement) to score 5 (worsening patient)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start1 Aug 2019
- Primary completion1 Nov 2023
- Study completion10 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 (actual)
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 faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538716
- Sponsor's protocol ID
- Hamaky6
- Status last verified
- Nov 2023
- First submitted
- 31 Aug 2020
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Elhamaky TR. Orbital fat graft retroseptal transconjunctival blepharoplasty for treatment of groove in the infraorbital region. Int Ophthalmol. 2024 May 6;44(1):217. doi: 10.1007/s10792-024-03148-z.
PubMed 38705907
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orbital Fat Graft Retroseptal Transconjunctival Blepharoplasty for Treatment of Groove in the Infraorbital Region
- ClinicalTrials.gov ID
- NCT04538716
- Acronym / sponsor ID
- Hamaky6
- Conditions
- Eyelid Diseases
- Keywords
- tear trough, blepharoplasty,orbital fat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 4 Sep 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.
The tear trough deformity is a challenging cosmetic condition.surgical treatment and filling are good treatment options
Detailed description
Procedure is lower eyelid transconjunctival Blepharoplasty associated with stromal vascular fraction gel (SVF-gel) or fat transposition
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SVF-gel | Experimental | Procedure: transconjunctival lower blepharoplastyTransconjunctival blepharoplasty associated with associated with stromal vascular fraction gel (SVF-gel) |
| fat transposition | Experimental | Procedure: transconjunctival lower blepharoplastyTransconjunctival blepharoplasty associated with fat transposition |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- tear trough deformity
Key exclusion criteria (1 listed)
- 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 |
|---|---|---|
| transconjunctival lower blepharoplastytransconjunctival lower blepharoplasty associated with stromal vascular fraction gel (SVF-gel) | Procedure or surgery | SVF-gel, fat transposition |
Primary outcome
skin-periosteal depth
Time frame: 2 years
measure skin-periosteal depth
1 secondary outcome
global aesthetic improvement scale
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Derived from this study: PubMed 38705907Elhamaky TR. Orbital fat graft retroseptal transconjunctival blepharoplasty for treatment of groove in the infraorbital region. Int Ophthalmol. 2024 May 6;44(1):217. doi: 10.1007/s10792-024-03148-z.
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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, 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?
A study testing transconjunctival lower 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: finished, as of the sponsor's last update on 15 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skin-periosteal depth (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04538716, which also lists 1 linked publication.
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 15 Nov 2023.