Evaluation of Intraoperative Lagophthalmos Formula

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

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Key information

Conditions

Ptosis, Eyelid Blepharoptosis Eye Diseases Eyelid Diseases

Age range

3 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ophthalmology Department, Menoufia University Hospital

Shibīn al Kawm, Menoufia, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levator muscle resection

Procedure

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 outcomes

Chick the validity of Lagophthalmos formula for Egyptian children with congenital ptosis

Time frame: 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

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

Evaluation of Intraoperative Lagophthalmos Formula for Levator Resection in Congenital Ptosis on Egyptian Patients

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Mar 2, 2020
Registry last updated: Mar 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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