EntropionNCT05371626
Cicatricial Upper Eyelid Entropion Management
A study testing Suture-less surgical procedure in people with Entropion, run by Minia University at 1 site in Egypt.
Trial summary
Suture-less technique will be used in treatment for cicatricial upper eyelid entropion to detect its long-term efficacy Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Entropion
- What is being tested?
- Suture-less surgical procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 5 May 2022to 1 Jun 2024
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Upper eyelid cicatricial entropion with no history of previous surgery.
- Cooperative patients older then 16 years old.
Who cannot join
- Previous lid surgery.
- Senile and mechanical entropion.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine
Minya, Minya Governorate, 61111
Mohamed FK Ibrahiem, MD, 00201064311860, mohamedfka@yahoo.com
About this study
Official title: Suture-less Procedure for Management of Cicatricial Upper Eyelid Entropion
Suture-less technique will be used in treatment for cicatricial upper eyelid entropion to detect its long-term efficacy
- Conditions
- Entropion
- Being tested
- Suture-less surgical procedure
- Medical subject headings
- Entropion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suture-less surgical procedureProcedure or surgery
Suture-less technique will be used in treatment for cicatricial upper eyelid entropion
| Study group | Role | What they receive |
|---|---|---|
| Suture-less entropion technique | Other | suture-less technique for cicatricial entropion Receives: Procedure: Suture-less surgical procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eyelid margin reposition to the normal position
posterior edge of eyelid opposed to eye globe using slit lamp examination of the inner margin of the upper lid
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start5 May 2022
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EntropionStudies of the same condition, open and under way.
- More trials run by Minia 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Farag Khalil Ibrahiem, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371626
- Sponsor's protocol ID
- Oculoplastic clinic
- Status last verified
- Oct 2023
- First submitted
- 5 May 2022
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suture-less Procedure for Management of Cicatricial Upper Eyelid Entropion
- ClinicalTrials.gov ID
- NCT05371626
- Acronym / sponsor ID
- Oculoplastic clinic
- Conditions
- Entropion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 5 May 2022 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 12 May 2022 (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.
Suture-less technique will be used in treatment for cicatricial upper eyelid entropion to detect its long-term efficacy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suture-less entropion technique | Other | Procedure: Suture-less surgical proceduresuture-less technique for cicatricial entropion |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Upper eyelid cicatricial entropion with no history of previous surgery.
- Cooperative patients older then 16 years old.
Key exclusion criteria (2 listed)
- Previous lid surgery.
- Senile and mechanical entropion.
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 |
|---|---|---|
| Suture-less surgical procedureSuture-less technique will be used in treatment for cicatricial upper eyelid entropion | Procedure or surgery | Suture-less entropion technique |
Primary outcome
Eyelid margin reposition to the normal position
Time frame: 1 month
posterior edge of eyelid opposed to eye globe using slit lamp examination of the inner margin of the upper lid
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suture-less surgical procedure in people with Entropion, run by Minia 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 2 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 23 Oct 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 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eyelid margin reposition to the normal position (time frame: 1 month). 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 23 Oct 2023.