Cicatricial TrichiasisNCT05634629
Anterior Lamellar Recession vs Bilamellar Tarsal Rotation in Upper Lid Cicatricial Trichiasis
A study testing Anterior Lamellar Recession and Bilamellar Tarsal Rotation in people with Cicatricial Trichiasis, run by Al-Azhar University at 1 site in Egypt.
Trial summary
in recent years there has been a significant shift from this destructive procedure to a reconstructive procedure such as Anterior Lamellar Recession (ALR) and Bilamellar Tarsal Rotation (BLTR). Read more about this study
- Who is it for?
- Ages 48 to 59 years
- Conditions the study is for
- Cicatricial Trichiasis
- What is being tested?
- Anterior Lamellar Recession and Bilamellar Tarsal Rotation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2021to 10 Nov 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 48 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with upper lid cicatricial trichiasis that requires surgical intervention
Who cannot join
- Refusal of the patients.
- Associated entropion., 3) Severe ocular surface disease.
- Previous eyelid surgery.
- Associated lid laxity.
- Lack of adequate follow-up
Trial locations and contacts
1 site in 1 country.
About this study
in recent years there has been a significant shift from this destructive procedure to a reconstructive procedure such as Anterior Lamellar Recession (ALR) and Bilamellar Tarsal Rotation (BLTR).
- Conditions
- Cicatricial Trichiasis
- Being tested
- Anterior Lamellar Recession, Bilamellar Tarsal Rotation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior Lamellar RecessionProcedure or surgery
ALR is a common surgical treatment that splits the skin and orbicularis oculi muscle from the tarsus and conjunctiva to recede the anterior lamella and expose the tarsus. Interlamellar separation can be accomplished via a grey line technique, an eyelid crease approach, or a combination of the two
Bilamellar Tarsal RotationProcedure or surgery
the full-thickness transverse blepharotomy combined with everting sutures to rotate the inferior portion of the upper lid outwards and this procedure has a low recurrence risk
| Study group | Role | What they receive |
|---|---|---|
| Anterior Lamellar Recession | Active comparator | Not described Receives: Procedure: Anterior Lamellar Recession |
| Bilamellar Tarsal Rotation | Active comparator | Not described Receives: Procedure: Bilamellar Tarsal Rotation |
What is being measured
The primary outcome is the main question the study is designed to answer.
lid correction
Its a subjective outcome that will be collected through an interview after the surgery. it consists of 3 sub domaines which include (adequate correction, undercorrection, and over corrections)
Measured: at 1 month post operative
lid correction
Its a subjective outcome that will be collected through an interview after the surgery. it consists of 3 sub domaines which include (adequate correction, undercorrection, and over corrections)
Measured: 3 months postoperative
lid correction
Its a subjective outcome that will be collected through an interview after the surgery. it consists of 3 sub domaines which include (adequate correction, undercorrection, and over corrections)
Measured: 6 months postoperative
Cosmetic Satisfaction
Its a subjective outcome that will be collected through an interview after the surgery.
Measured: at 1 months post operative
Cosmetic Satisfaction
Its a subjective outcome that will be collected through an interview after the surgery.
Measured: at 3 months post operative
Cosmetic Satisfaction
Its a subjective outcome that will be collected through an interview after the surgery.
Measured: at 6 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 posted2 Dec 2022
- Study start15 Jun 2021
- Primary completion1 Nov 2022
- Study completion10 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cicatricial TrichiasisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 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
- NCT05634629
- Sponsor's protocol ID
- cicatricial trichiasi
- Status last verified
- Nov 2022
- First submitted
- 23 Nov 2022
- Last updated
- 2 Dec 2022
- 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 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Lamellar Recession vs Bilamellar Tarsal Rotation in Upper Lid Cicatricial Trichiasis
- ClinicalTrials.gov ID
- NCT05634629
- Acronym / sponsor ID
- cicatricial trichiasi
- Conditions
- Cicatricial Trichiasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 2 Dec 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.
in recent years there has been a significant shift from this destructive procedure to a reconstructive procedure such as Anterior Lamellar Recession (ALR) and Bilamellar Tarsal Rotation (BLTR).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior Lamellar Recession | Active comparator | Procedure: Anterior Lamellar Recession |
| Bilamellar Tarsal Rotation | Active comparator | Procedure: Bilamellar Tarsal Rotation |
Who may qualify
- Ages
- 48 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with upper lid cicatricial trichiasis that requires surgical intervention
Key exclusion criteria (5 listed)
- Refusal of the patients.
- Associated entropion., 3) Severe ocular surface disease.
- Previous eyelid surgery.
- Associated lid laxity.
- Lack of adequate follow-up
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 |
|---|---|---|
| Anterior Lamellar RecessionALR is a common surgical treatment that splits the skin and orbicularis oculi muscle from the tarsus and conjunctiva to recede the anterior lamella and expose the tarsus. Interlamellar separation can be accomplished via a grey line technique, an eyelid crease approach, or a combination of the two | Procedure or surgery | Anterior Lamellar Recession |
| Bilamellar Tarsal Rotationthe full-thickness transverse blepharotomy combined with everting sutures to rotate the inferior portion of the upper lid outwards and this procedure has a low recurrence risk | Procedure or surgery | Bilamellar Tarsal Rotation |
Primary outcome
lid correction
Time frame: at 1 month post operative
Its a subjective outcome that will be collected through an interview after the surgery. it consists of 3 sub domaines which include (adequate correction, undercorrection, and over corrections)
lid correction
Time frame: 3 months postoperative
Its a subjective outcome that will be collected through an interview after the surgery. it consists of 3 sub domaines which include (adequate correction, undercorrection, and over corrections)
lid correction
Time frame: 6 months postoperative
Its a subjective outcome that will be collected through an interview after the surgery. it consists of 3 sub domaines which include (adequate correction, undercorrection, and over corrections)
Cosmetic Satisfaction
Time frame: at 1 months post operative
Its a subjective outcome that will be collected through an interview after the surgery.
Cosmetic Satisfaction
Time frame: at 3 months post operative
Its a subjective outcome that will be collected through an interview after the surgery.
Cosmetic Satisfaction
Time frame: at 6 months post operative
Its a subjective outcome that will be collected through an interview after the surgery.
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 2 Dec 2022.
- Individual participant dataSharing planned: Undecided
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 Anterior Lamellar Recession and Bilamellar Tarsal Rotation in people with Cicatricial Trichiasis, 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 1 inclusion and 5 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 2 Dec 2022. 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?
lid correction (time frame: at 1 month post operative). The study lists 6 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 2 Dec 2022.