Eyelid DefectsNCT04952116
Aesthetic and Functional Outcomes of Eyelid Reconstruction After Excision of Periocular Tumors
A study testing Eyelid reconstruction in people with Eyelid Defects and Periocular Tumors, run by Sohag University at 1 site in Egypt.
Trial summary
To determine the aesthetic and functional outcomes of different techniques used in eyelid reconstruction following periocular defects. To determine the complications of eyelid reconstruction and how to prevent them Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Eyelid Defects, Periocular Tumors
- What is being tested?
- Eyelid reconstruction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2021to 1 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with periocular tumors and candidate for excision
Who cannot join
- patients with history of radiotherapy or chemotherapy
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag university
Sohag
Hassan Noman, Professor, 0934602963, Portal@med.sohag.edu.eg
About this study
- To determine the aesthetic and functional outcomes of different techniques used in eyelid reconstruction following periocular defects.
- To determine the complications of eyelid reconstruction and how to prevent them
Read the detailed description
Patients will undergo the following :
Direct eyelid closure will be done in small defects with or without canthyolysis Larger defects will be reconstructed with anterior and posterior lamella reconstruction using grafts and flaps
Patients will be followed up as regard
- The stability of flap or graft
- The vertical and horizontal measurements of palbepral fissure
- Detection of any complications
- Donor site follow up
- Patient degree of satisfaction
- Conditions
- Eyelid Defects, Periocular Tumors
- Being tested
- Eyelid reconstruction
- Keywords
- Eyelid, Reconstruction, periocular tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eyelid reconstructionOther
Assessment of differrent techniques in anterior and posterior lamella reconstruction after periocular defects
| Study group | Role | What they receive |
|---|---|---|
| Eyelid reconstruction | Other | Direct eyelid closure will be done in small defects after periocular defects with or without canthyolysis , Larger defects will be reconstructed with anterior and posterior lamella reconstruction using grafts and flaps Receives: Other: Eyelid reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stability of graft or flap
Assessment of flap or graft as regard the function , stability and colour match
Measured: 9 months
Measurement of vertical and horizontal diameters of the palbepral fissure
Measurement of the length between the inner and outer canthus by ruler to determine the horizontal diameter of the palbepral fissure , and measurement of the distance between upper and lower lid margins at the pupil center to determine the vertical palbepral fissure diameter
Measured: 9 months
Secondary outcomes (2)
Donor site
Follow up of donor site
Measured: 9 months
complications
Follow up of complications
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start1 Aug 2021 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 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 DefectsStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haitham Thabit, Sohag University
- Investigators
- Ali Ismail, Professor, Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952116
- Sponsor's protocol ID
- Soh-Med-21-05-13
- Status last verified
- Jun 2021
- First submitted
- 21 Jun 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The Functional and cosmetic outcomes of differrent methods of eye lid reconstruction
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aesthetic and Functional Outcomes of Eyelid Reconstruction After Excision of Periocular Tumors
- ClinicalTrials.gov ID
- NCT04952116
- Acronym / sponsor ID
- Soh-Med-21-05-13
- Conditions
- Eyelid Defects, Periocular Tumors
- Keywords
- Eyelid, Reconstruction, periocular tumors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 7 Jul 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.
- To determine the aesthetic and functional outcomes of different techniques used in eyelid reconstruction following periocular defects.
- To determine the complications of eyelid reconstruction and how to prevent them
Detailed description
Patients will undergo the following :
Direct eyelid closure will be done in small defects with or without canthyolysis Larger defects will be reconstructed with anterior and posterior lamella reconstruction using grafts and flaps
Patients will be followed up as regard
- The stability of flap or graft
- The vertical and horizontal measurements of palbepral fissure
- Detection of any complications
- Donor site follow up
- Patient degree of satisfaction
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eyelid reconstruction | Other | Other: Eyelid reconstructionDirect eyelid closure will be done in small defects after periocular defects with or without canthyolysis , Larger defects will be reconstructed with anterior and posterior lamella reconstruction using grafts and flaps |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with periocular tumors and candidate for excision
Key exclusion criteria (1 listed)
- patients with history of radiotherapy or chemotherapy
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 |
|---|---|---|
| Eyelid reconstructionAssessment of differrent techniques in anterior and posterior lamella reconstruction after periocular defects | Other | Eyelid reconstruction |
Primary outcome
Stability of graft or flap
Time frame: 9 months
Assessment of flap or graft as regard the function , stability and colour match
Measurement of vertical and horizontal diameters of the palbepral fissure
Time frame: 9 months
Measurement of the length between the inner and outer canthus by ruler to determine the horizontal diameter of the palbepral fissure , and measurement of the distance between upper and lower lid margins at the pupil center to determine the vertical palbepral fissure diameter
2 secondary outcomes
Donor site
Time frame: 9 months
complications
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Individual participant dataSharing planned: Undecided. The Functional and cosmetic outcomes of differrent methods of eye lid reconstruction
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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.
Ali Ismail, Professor study director
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eyelid reconstruction in people with Eyelid Defects and Periocular Tumors, run by Sohag University at 1 site in Egypt.
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 7 Jul 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 Egypt. 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 Haitham Thabit, Master (01019275238, Hytham.Thaber@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stability of graft or flap (time frame: 9 months). The study lists 2 primary outcomes in all. 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 7 Jul 2021.