Transcutaneous Levator Recession for Non-thyroid Lid Retraction

Sponsor

Al-Azhar University (Other)

Overall Status

Completed

CT.gov ID

NCT05671120

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Eye Diseases	Procedure: Transcutaneous levator recession	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Transcutaneous Levator Recession for Non-thyroid Lid Retraction

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Jun 1, 2021

Actual Study Completion Date :

Aug 2, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Margin reflex distance (MRD1) [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) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ehab tharwat	Damieta	New Damietta	Egypt	34517

Sponsors and Collaborators

Al-Azhar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ehab tharwat, Principal investigator, Al-Azhar University

ClinicalTrials.gov Identifier:

NCT05671120

Other Study ID Numbers:

levator recession

First Posted:

Jan 4, 2023

Last Update Posted:

Jan 4, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Eye Diseases

Study Results

No Results Posted as of Jan 4, 2023