Back to resultsTranscutaneous Levator Recession for Non-thyroid Lid Retraction
Primary Purpose
Eye Diseases
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Transcutaneous levator recession
Sponsored by
About this trial
This is an interventional treatment trial for Eye Diseases
Eligibility Criteria
Inclusion Criteria: Patients suffering from upper eyelid retraction of various causes other than thyroid eye disease Exclusion Criteria: 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
Sites / Locations
- Ehab tharwat
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Transcutaneous levator recession
Arm Description
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05671120
Brief Title
Transcutaneous Levator Recession for Non-thyroid Lid Retraction
Official Title
Transcutaneous Levator Recession for Non-thyroid Lid Retraction
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
August 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transcutaneous levator recession
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Transcutaneous levator recession
Intervention Description
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
Primary Outcome Measure Information:
Title
Margin reflex distance (MRD1)
Description
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
Time Frame
Baseline
Title
Margin reflex distance (MRD1)
Description
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
Time Frame
at one month post operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients suffering from upper eyelid retraction of various causes other than thyroid eye disease
Exclusion Criteria:
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
Facility Information:
Facility Name
Ehab tharwat
City
Damieta
State/Province
New Damietta
ZIP/Postal Code
34517
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Transcutaneous Levator Recession for Non-thyroid Lid Retraction
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