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Evaluation of Intraoperative Lagophthalmos Formula

M

Menoufia University

Status

Completed

Conditions

Ptosis, Eyelid

Treatments

Procedure: Levator muscle resection

Study type

Interventional

Funder types

Other

Identifiers

NCT04291625
19519OPHT38

Details and patient eligibility

About

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

Full 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.

Enrollment

20 patients

Sex

All

Ages

3 to 15 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

congenital ptosis
Other group
Description:
children who had congenital ptosis with levator function of 4mm or better, underwent levator muscle resection guided by intraoperative lagophthalmos formula.
Treatment:
Procedure: Levator muscle resection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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