Study of Clinical Types and Treatment Outcomes of Pediatric Esotropia in Sohag University Hospital

Strabismus (or squint) is defined as the presence of misalignment between the visual axes of the 2 eyes presenting with deviation of the eyes. Strabismus is further subdivided into comitant (if the amount of misalignment between the 2 eyes remained equal in all directions of gaze) and incomitant (if the amount of misalignment varied in different directions of gaze). If the squinting eye was deviated inward, it is termed as a convergent squint or esotropia and if the squinting eye is deviated outward, it is termed as a divergent squint or exotropia. Pediatric esotropia may be congenital or acquired. Congenital esotropia is a well-defined entity with an onset prior to 6 months of age, characterised by a large stable angle, cross fixation, and a limited potential for binocular single vision. Acquired childhood esotropia may be paralytic or non-paralytic. The non-paralytic or concomitant type, which is neither congenital nor secondary to ocular pathology, can be divided into three main groups: (1) Accommodative esotropia, which may be fully accommodative, partially accommodative, or accommodative with convergence excess; (2) Non-accommodative esotropia; (3) Esotropia associated with neurological dysfunction, in particular cerebral palsy and hydrocephalus. The last group of esotropia will be excluded from our study. Pediatric strabismus must be treated early to maximize the potential for binocular vision and decrease the risk of amblyopia. Treatment goals include good vision in each eye (no amblyopia) and straight eyes (orthotropia). Both conditions are necessary to produce stereopsis, which is a third goal. Strabismus in children may result in undesirable appearance, amblyopia, impaired stereopsis, diplopia, and negative psychological effect.

Study Overview

• Status: Completed
• Conditions: Infantile Esotropia
• Intervention / Treatment: Procedure: bilateral medial rectus recession

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag University hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Infants and children up to the age of 12 years.
2. Primary Concomitant convergent squint (1ry concomitant esotropia)
3. Candidate for surgical correction of squint

Exclusion Criteria:

• 1. Children with:

  1. Paralytic squint
  2. Consecutive esotropia
  3. Any neurological disorders e.g. hydrocephalus.
  4. History of previous squint surgery
  5. History of previous other ocular surgery (e.g. congenital cataract & glaucoma) 2. Children who missed follow up.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: congenital esotropia; will be defined as that type of esotropia with an onset prior to 6 months of age & characterized by a large stable angle	Procedure: bilateral medial rectus recession; release muuscle from its original insertion and backword inserted in sclera; Other Names: Monocular medial rectus (MR) recession and lateral rectus (LR) resection
Active Comparator: accommodative esotropia; Fully accommodative esotropia will be defined as an esotropia which is controlled for distance and near with full hypermetropic correction. Partially accommodative esotropia will be defined as a reduction in the angle of esotropia of 10 dioptres or more for distance or near, using the full hypermetropic correctionAccommodative esotropia with convergence excess occurs when the near angle exceeded the distance angle by 15 dioptres or more when fixating an accommodative target, using the full hypermetropic correction.	Procedure: bilateral medial rectus recession; release muuscle from its original insertion and backword inserted in sclera; Other Names: Monocular medial rectus (MR) recession and lateral rectus (LR) resection
Active Comparator: non-accommodative esotropia; neither congenital nor accommodative esotropia	Procedure: bilateral medial rectus recession; release muuscle from its original insertion and backword inserted in sclera; Other Names: Monocular medial rectus (MR) recession and lateral rectus (LR) resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
orthotropia	eye alignment	6 months
residual esotropia	esotropia >10PD undercorrection	6months
consecuative exotropia	exotropia > 10PD overcorrection	6 months

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• Mohney BG. Common forms of childhood strabismus in an incidence cohort. Am J Ophthalmol. 2007 Sep;144(3):465-7. doi: 10.1016/j.ajo.2007.06.011.
• Rubin SE, Nelson LB, Wagner RS, Simon JW, Catalano RA. Infantile exotropia in healthy children. Ophthalmic Surg. 1988 Nov;19(11):792-4. doi: 10.3928/0090-4481-19881101-07.
• von Noorden GK. Bowman lecture. Current concepts of infantile esotropia. Eye (Lond). 1988;2 ( Pt 4):343-57. doi: 10.1038/eye.1988.65.
• Mulvihill A, MacCann A, Flitcroft I, O'Keefe M. Outcome in refractive accommodative esotropia. Br J Ophthalmol. 2000 Jul;84(7):746-9. doi: 10.1136/bjo.84.7.746.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: January 14, 2024
• First Submitted That Met QC Criteria: January 14, 2024
• First Posted (Actual): January 24, 2024

Study Record Updates

• Last Update Posted (Actual): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 14, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Ocular Motility Disorders; Strabismus; Esotropia
• Other Study ID Numbers: soh-med-22-04-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No