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Evaluation of Intraoperative Lagophthalmos Formula

Primary Purpose

Ptosis, Eyelid

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Levator muscle resection
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ptosis, Eyelid focused on measuring congenital, ptosis, levator function, MRD 1

Eligibility Criteria

3 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • simple congenital ptosis (any degree) with levator function of 4mm or more

Exclusion Criteria:

  • levator function less than 4mm
  • a history of previous ptosis surgery
  • other accompanying congenital diseases, such as blepharophimosis, congenital fibrosis of the extraocular muscles, Marcus Gunn (jaw-winking) syndrome, double elevator palsy and congenital third nerve palsy

Sites / Locations

  • Ophthalmology Department, Menoufia University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

congenital ptosis

Arm Description

children who had congenital ptosis with levator function of 4mm or better, underwent levator muscle resection guided by intraoperative lagophthalmos formula.

Outcomes

Primary Outcome Measures

Chick the validity of Lagophthalmos formula for Egyptian children with congenital ptosis
We apply the following formula: Intraoperative lagophthalmos=9.08 - 0.48×Preoperative MRD1 - 0.26×Levator function. We tried to achieve the calculated lagophthalmos by the formula intraoperatively

Secondary Outcome Measures

Full Information

First Posted
February 27, 2020
Last Updated
February 27, 2020
Sponsor
Menoufia University
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1. Study Identification

Unique Protocol Identification Number
NCT04291625
Brief Title
Evaluation of Intraoperative Lagophthalmos Formula
Official Title
Evaluation of Intraoperative Lagophthalmos Formula for Levator Resection in Congenital Ptosis on Egyptian Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
February 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia 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 is a prospective non-randomized study to evaluate the recent intraoperative lagophthalmos formula method for levator resection in determining postoperative eyelid height in congenital ptosis on Egyptian children. included 20 eyelids from 17 Egyptian children with congenital ptosis with levator function of 4mm or better, they underwent levator muscle resection guided by the recent intraoperative lagophthalmos formula
Detailed Description
This is a prospective non-randomized study to evaluate the recent intraoperative lagophthalmos formula method for levator resection in determining postoperative eyelid height in congenital ptosis on Egyptian children. The study included 20 eyelids of 17 Egyptian children with congenital ptosis with levator function of 4mm or better, they underwent levator muscle resection guided by the recent intraoperative lagophthalmos formula. Preoperative MRD 1 (Margin-to-reflex distance 1) and levator function were measured, then intraoperative palpebral fissure opening was determined from formula: Intraoperative lagophthalmos=9.08 - 0.48×Preoperative MRD1 - 0.26× Levator function. Postoperative MRD 1 was measured after 1 day, 1week,1month, 3 months and 6 months .Success was defined as postoperative MRD 1 ≥ 3 mm and difference between both eyelids height ≤ 1 mm at 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ptosis, Eyelid
Keywords
congenital, ptosis, levator function, MRD 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
20 eyelids with congenital ptosis with levator function of 4 mm or better, who underwent levator muscle resection guided by the recent intraoperative lagophthalmos formula.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
congenital ptosis
Arm Type
Other
Arm Description
children who had congenital ptosis with levator function of 4mm or better, underwent levator muscle resection guided by intraoperative lagophthalmos formula.
Intervention Type
Procedure
Intervention Name(s)
Levator muscle resection
Intervention Description
Surgery was performed under general anaesthesia. Two milliliters of 2% lidocaine with 1:100 000 epinephrine is injected subcutaneously. After the upper eyelid incision at the desired crease line, the orbital septum was opened and the preaponeurotic fat was identified and dissected off the levator aponeurosis. The aponeurosis was disinserted from the tarsus, and the complex of levator aponeurosis and Muller muscle was dissected free from the conjunctiva. The desired eyelid height was determined from the proposed formula. Satisfactory Intraoperative lagophthalmos was defined as a difference of less than 1 mm between recommended by the formula and actual intraoperative lagophthalmos. After permanent fixation, a caliper was used for precise measurement of lagophthalmos in a supine position. Additional sutures were placed on the medial and lateral sides for satisfactory eyelid contour. The redundant levator complex was excised. Eyelid crease was made by placing three interrupted sutures
Primary Outcome Measure Information:
Title
Chick the validity of Lagophthalmos formula for Egyptian children with congenital ptosis
Description
We apply the following formula: Intraoperative lagophthalmos=9.08 - 0.48×Preoperative MRD1 - 0.26×Levator function. We tried to achieve the calculated lagophthalmos by the formula intraoperatively
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: simple congenital ptosis (any degree) with levator function of 4mm or more Exclusion Criteria: levator function less than 4mm a history of previous ptosis surgery other accompanying congenital diseases, such as blepharophimosis, congenital fibrosis of the extraocular muscles, Marcus Gunn (jaw-winking) syndrome, double elevator palsy and congenital third nerve palsy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarek Rakha, MBBch
Organizational Affiliation
Kafr Elsheikh eye surgery center, Kafr Elsheikh, Egypt
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Amr Awara, MD
Organizational Affiliation
Tanta University, Tanta, Gharbia, Egypt
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Abdel Khalek I Elsaadany, PhD
Organizational Affiliation
Menoufia University, Shebin El Koum, Menoufia, Egypt
Official's Role
Study Director
Facility Information:
Facility Name
Ophthalmology Department, Menoufia University Hospital
City
Shibīn Al Kawm
State/Province
Menoufia
Country
Egypt

12. IPD Sharing Statement

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Evaluation of Intraoperative Lagophthalmos Formula

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