Evaluation of Intraoperative Lagophthalmos Formula

Not Applicable

Completed

• Conditions: Ptosis, Eyelid
• Interventions: Procedure: Levator muscle resection

• Registration Number: NCT04291625
• Lead Sponsor: Menoufia University

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.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2020-01-01
• Status Verified: 2020-02
• Study Completion: 2020-02-15
• Study First Submitted: 2020-02-27
• Study First Submitted QC: 2020-02-27
• Last Update Submitted: 2020-02-27
• Study First Posted: 2020-03-02
• Last Update Posted: 2020-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Chick the validity of Lagophthalmos formula for Egyptian children with congenital ptosis	6 months	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

Trial Locations

Locations (1)

Ophthalmology Department, Menoufia University Hospital; 🇪🇬 Shibīn Al Kawm, Menoufia, Egypt