Evaluation of Intraoperative Lagophthalmos Formula

NCT04291625 | Completed

• 1 other identifier: 19519OPHT38
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Ptosis, Eyelid

Keywords

congenital; ptosis; levator function; MRD 1

Outcome Measures

Primary Outcomes (1)

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

  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

  6 months

Study Arms (1)

congenital ptosis

OTHER

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

Procedure: Levator muscle resection

Interventions

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

congenital ptosis

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• simple congenital ptosis (any degree) with levator function of 4mm or more

You may not qualify if:

• 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

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Ophthalmology Department, Menoufia University Hospital

Shibīn al Kawm, Menoufia, Egypt

Location

MeSH Terms

Conditions

Blepharoptosis

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Study Officials

• Tarek Rakha, MBBch

  Kafr Elsheikh eye surgery center, Kafr Elsheikh, Egypt

  STUDY CHAIR

• Amr Awara, MD

  Tanta University, Tanta, Gharbia, Egypt

  STUDY CHAIR

• Abdel Khalek I Elsaadany, PhD

  Menoufia University, Shebin El Koum, Menoufia, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Ophthalmology

Model Details: 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.

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 2, 2020
• Study Start: January 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: February 15, 2020
• Last Updated: March 2, 2020

Record last verified: 2020-02

Locations

EG (1)