NCT05671120

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 1, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 4, 2023

Completed
Last Updated

January 4, 2023

Status Verified

January 1, 2023

Enrollment Period

2.4 years

First QC Date

January 1, 2023

Last Update Submit

January 1, 2023

Conditions

Eye Diseases

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Transcutaneous levator recession

OTHER
Procedure: Transcutaneous levator recession

Interventions

Transcutaneous levator recessionPROCEDURE

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

Transcutaneous levator recession

Eligibility Criteria

Age12 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients suffering from upper eyelid retraction of various causes other than thyroid eye disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ehab tharwat

Damietta, New Damietta, 34517, Egypt

Location

MeSH Terms

Conditions

Eye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 1, 2023

First Posted

January 4, 2023

Study Start

January 1, 2019

Primary Completion

June 1, 2021

Study Completion

August 2, 2021

Last Updated

January 4, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)