Transcutaneous Levator Recession for Non-thyroid Lid Retraction

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 Overview

• Status: Completed
• Conditions: Eye Diseases
• Intervention / Treatment: Procedure: Transcutaneous levator recession

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • New Damietta
    • Damieta, New Damietta, Egypt, 34517
      • Ehab tharwat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Transcutaneous levator recession	Procedure: Transcutaneous levator recession; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	at one month post operative

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): August 2, 2021

Study Registration Dates

• First Submitted: January 1, 2023
• First Submitted That Met QC Criteria: January 1, 2023
• First Posted (Estimate): January 4, 2023

Study Record Updates

• Last Update Posted (Estimate): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 1, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases
• Other Study ID Numbers: levator recession

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No