Evaluation of Intraoperative Lagophthalmos Formula

NCT ID: NCT04291625

Last Updated: 2020-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2020-02-15

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.

Conditions

Ptosis, Eyelid

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

congenital ptosis

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

Group Type: OTHER

Levator muscle resection

Intervention Type: 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

Interventions

Levator muscle resection

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

Sameh S. Mandour

Assistant Professor of Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tarek Rakha, MBBch

Role: STUDY_CHAIR

Kafr Elsheikh eye surgery center, Kafr Elsheikh, Egypt

Amr Awara, MD

Role: STUDY_CHAIR

Tanta University, Tanta, Gharbia, Egypt

Abdel Khalek I Elsaadany, PhD

Role: STUDY_DIRECTOR

Menoufia University, Shebin El Koum, Menoufia, Egypt

Locations

Ophthalmology Department, Menoufia University Hospital

Shibīn al Kawm, Menoufia, Egypt

Countries

Egypt

Other Identifiers

19519OPHT38

Identifier Type: -

Identifier Source: org_study_id