EntropionNCT05854420
Modified Anterior Lamellar Recession for All Grades of Upper Eyelid Trachomatous Cicatricial Entropion
A study testing Modified anterior Lamellar Recession in people with Entropion, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This study aims to assess the combination of anterior lamellar recession (ALR) with blepharoplasty, suprasternal fixation, and internal eyelash bulb extirpation of aberrant lashes posteriorly located in patients with any grade of upper eyelid trachomatous cicatricial entropion Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Entropion
- What is being tested?
- Modified anterior Lamellar Recession
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2018to 15 Mar 2021
- 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 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All patients presented with upper lid trachomatous cicatricial entropion associated with rubbing lashes.
- Patients having a history of argon laser ablation, electrolysis, epilation, or past unsuccessful surgery were also included
Who cannot join
- Patients with a follow-up period of fewer than 12 months.
- Patients with very severe UCE and required posterior lamellar grafts.
- Patients with etiology other than trachoma.
- Patients with dysplastic lashes without entropion were excluded
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to assess the combination of anterior lamellar recession (ALR) with blepharoplasty, suprasternal fixation, and internal eyelash bulb extirpation of aberrant lashes posteriorly located in patients with any grade of upper eyelid trachomatous cicatricial entropion
- Conditions
- Entropion
- Being tested
- Modified anterior Lamellar Recession
- Medical subject headings
- Entropion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified anterior Lamellar RecessionProcedure or surgery
ALR is one of the procedures used to treat cicatricial entropion and trichiasis. Few studies present the effect of modifications to this procedure in trachomatous entropion and trichiasis. Because trachoma is common in our country, there is a probability that the number of surgeries for TT will rise.
| Study group | Role | What they receive |
|---|---|---|
| Modified anterior Lamellar Recession | Experimental | All patients in this arm underwent a combination of ALR, blepharoplasty, suprasternal fixation, and cauterization or internal bulb extirpation of posteriorly located lashes. Receives: Procedure: Modified anterior Lamellar Recession |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
The cases will be considered succeed if there is no recurrence of the entropion
Measured: 3 months post operative
Success rate
The cases will be considered succeed if there is no recurrence of the entropion
Measured: 6 months post operative
Success rate
The cases will be considered succeed if there is no recurrence of the entropion
Measured: 9 months post operative
Success rate
The cases will be considered succeed if there is no recurrence of the entropion
Measured: 12 months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start1 May 2018
- Primary completion1 Mar 2021
- Study completion15 Mar 2021
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 Al-Azhar 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
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Tharwat, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854420
- Sponsor's protocol ID
- Modified ALR
- Status last verified
- May 2023
- First submitted
- 3 May 2023
- Last updated
- 11 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Anterior Lamellar Recession for All Grades of Upper Eyelid Trachomatous Cicatricial Entropion
- ClinicalTrials.gov ID
- NCT05854420
- Acronym / sponsor ID
- Modified ALR
- Conditions
- Entropion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 11 May 2023 (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.
This study aims to assess the combination of anterior lamellar recession (ALR) with blepharoplasty, suprasternal fixation, and internal eyelash bulb extirpation of aberrant lashes posteriorly located in patients with any grade of upper eyelid trachomatous cicatricial entropion
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modified anterior Lamellar Recession | Experimental | Procedure: Modified anterior Lamellar RecessionAll patients in this arm underwent a combination of ALR, blepharoplasty, suprasternal fixation, and cauterization or internal bulb extirpation of posteriorly located lashes. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All patients presented with upper lid trachomatous cicatricial entropion associated with rubbing lashes.
- Patients having a history of argon laser ablation, electrolysis, epilation, or past unsuccessful surgery were also included
Key exclusion criteria (4 listed)
- Patients with a follow-up period of fewer than 12 months.
- Patients with very severe UCE and required posterior lamellar grafts.
- Patients with etiology other than trachoma.
- Patients with dysplastic lashes without entropion were excluded
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 |
|---|---|---|
| Modified anterior Lamellar RecessionALR is one of the procedures used to treat cicatricial entropion and trichiasis. Few studies present the effect of modifications to this procedure in trachomatous entropion and trichiasis. Because trachoma is common in our country, there is a probability that the number of surgeries for TT will rise. | Procedure or surgery | Modified anterior Lamellar Recession |
Primary outcome
Success rate
Time frame: 3 months post operative
The cases will be considered succeed if there is no recurrence of the entropion
Success rate
Time frame: 6 months post operative
The cases will be considered succeed if there is no recurrence of the entropion
Success rate
Time frame: 9 months post operative
The cases will be considered succeed if there is no recurrence of the entropion
Success rate
Time frame: 12 months post operative
The cases will be considered succeed if there is no recurrence of the entropion
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 11 May 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified anterior Lamellar Recession in people with Entropion, run by Al-Azhar 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 4 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 11 May 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?
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?
Success rate (time frame: 3 months post operative). The study lists 4 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 11 May 2023.