Clinical trial NCT04291625: Evaluation of Intraoperative Lagophthalmos Formula
Official title: Evaluation of Intraoperative Lagophthalmos Formula for Levator Resection in Congenital Ptosis on Egyptian Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ptosis, Eyelid
Keywords: congenital
ptosis
levator function
MRD 1
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 20
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Chick the validity of Lagophthalmos formula for Egyptian children with congenital ptosis
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Ophthalmology Department, Menoufia University Hospital
state: Menoufia
Study officials:
affiliation: Kafr Elsheikh eye surgery center, Kafr Elsheikh, Egypt
name: Tarek Rakha, MBBch
role: STUDY_CHAIR
affiliation: Tanta University, Tanta, Gharbia, Egypt
name: Amr Awara, MD
role: STUDY_CHAIR
affiliation: Menoufia University, Shebin El Koum, Menoufia, Egypt
name: Abdel Khalek I Elsaadany, PhD
role: STUDY_DIRECTOR
References: