Eye DiseasesNCT05671120
Transcutaneous Levator Recession for Non-thyroid Lid Retraction
A study testing Transcutaneous levator recession in people with Eye Diseases, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This work aims to describe and assess the efficacy of transcutaneous levator palpebrea superioris muscle recession as a surgical procedure for treatment of upper lid retraction of various causes other than thyroid eye disease Read more about this study
- Who is it for?
- Ages 12 to 55 years
- Conditions the study is for
- Eye Diseases
- What is being tested?
- Transcutaneous levator recession
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 2 Aug 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 12 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients suffering from upper eyelid retraction of various causes other than thyroid eye disease
Who cannot join
- Patients refused to participate in the study, patients with systemic diseases causing lid retraction (such as Guillain-Barré syndrome), pseudo retractions, contralateral ptosis, local skin condition (as scar adherence), medication (such as sympathomimetic drugs, lithium, and steroid), neurological conditions (such as dorsal midbrain syndrome and hydrocephalus) and thyroid related lid retraction
Trial locations and contacts
1 site in 1 country.
About this study
This work aims to describe and assess the efficacy of transcutaneous levator palpebrea superioris muscle recession as a surgical procedure for treatment of upper lid retraction of various causes other than thyroid eye disease
- Conditions
- Eye Diseases
- Being tested
- Transcutaneous levator recession
- Medical subject headings
- Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous levator recessionProcedure or surgery
recession of the upper and lower eyelid retractors can improve the upper eyelid contour if the patient has lateral flare (common in TED). The choice of procedure depends on severity of lid retraction and associated features like proptosis, status of extraocular muscles, and corneal condition
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous levator recession | Other | Not described Receives: Procedure: Transcutaneous levator recession |
What is being measured
The primary outcome is the main question the study is designed to answer.
Margin reflex distance (MRD1)
MRD1 is a commonly used parameter in the assessment of patients with blepharoptosis and is defined as the distance between the upper lid margin and the corneal reflex when the eye is in the primary position
Measured: Baseline
Margin reflex distance (MRD1)
MRD1 is a commonly used parameter in the assessment of patients with blepharoptosis and is defined as the distance between the upper lid margin and the corneal reflex when the eye is in the primary position
Measured: at one month post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start1 Jan 2019
- Primary completion1 Jun 2021
- Study completion2 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseasesStudies of the same condition, open and under way.
- 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
- 19 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
- NCT05671120
- Sponsor's protocol ID
- levator recession
- Status last verified
- Jan 2023
- First submitted
- 1 Jan 2023
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- 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 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Levator Recession for Non-thyroid Lid Retraction
- ClinicalTrials.gov ID
- NCT05671120
- Acronym / sponsor ID
- levator recession
- Conditions
- Eye Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 2 Aug 2021 (actual)
- First posted
- 4 Jan 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 work aims to describe and assess the efficacy of transcutaneous levator palpebrea superioris muscle recession as a surgical procedure for treatment of upper lid retraction of various causes other than thyroid eye disease
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous levator recession | Other | Procedure: Transcutaneous levator recession |
Who may qualify
- Ages
- 12 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients suffering from upper eyelid retraction of various causes other than thyroid eye disease
Key exclusion criteria (1 listed)
- Patients refused to participate in the study, patients with systemic diseases causing lid retraction (such as Guillain-Barré syndrome), pseudo retractions, contralateral ptosis, local skin condition (as scar adherence), medication (such as sympathomimetic drugs, lithium, and steroid), neurological conditions (such as dorsal midbrain syndrome and hydrocephalus) and thyroid related lid retraction
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 |
|---|---|---|
| Transcutaneous levator recessionrecession of the upper and lower eyelid retractors can improve the upper eyelid contour if the patient has lateral flare (common in TED). The choice of procedure depends on severity of lid retraction and associated features like proptosis, status of extraocular muscles, and corneal condition | Procedure or surgery | Transcutaneous levator recession |
Primary outcome
Margin reflex distance (MRD1)
Time frame: Baseline
MRD1 is a commonly used parameter in the assessment of patients with blepharoptosis and is defined as the distance between the upper lid margin and the corneal reflex when the eye is in the primary position
Margin reflex distance (MRD1)
Time frame: at one month post operative
MRD1 is a commonly used parameter in the assessment of patients with blepharoptosis and is defined as the distance between the upper lid margin and the corneal reflex when the eye is in the primary position
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 4 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Eye Diseases
Not yet recruitingPhase 2
A Phase 2 Study to Compare Efficacy and Safety of a Novel Topical Therapy (APT-001, Spinosad 1.8%) in Patients With Blepharitis
Blepharitis
Not yet recruiting
PAUL® Glaucoma Implant Safety and Effectiveness Study
Refractory Glaucoma
Not yet recruitingObservational study
Corneal Biomechanics and Stromal Tissue Characteristics in Patients Undergoing SMILE
Myopia
Active, not recruitingPhase 4
A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration
Geographic Atrophy, Age-Related Macular Degeneration
RecruitingPhase 2
A Proof-Of-Concept (POC) Study of SFG-02 Transdermal Formulation in Participants With Underactive Bladder (UAB)
Participants With Underactive Bladder (UAB)
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 Transcutaneous levator recession in people with Eye Diseases, 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 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 4 Jan 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?
Margin reflex distance (MRD1) (time frame: Baseline). 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 4 Jan 2023.