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Completed

NCT Number: NCT06221098

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.

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Key information

Conditions

Age range

1 day–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sohag University hospitals

Sohag, Egypt

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

bilateral medial rectus recession

Procedure

release muuscle from its original insertion and backword inserted in sclera

Other names: Monocular medial rectus (MR) recession and lateral rectus (LR) resection

Primary outcomes

  1. orthotropia

    Time frame: 6 months

    eye alignment

  2. residual esotropia

    Time frame: 6months

    esotropia >10PD undercorrection

  3. consecuative exotropia

    Time frame: 6 months

    exotropia > 10PD overcorrection

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 24, 2024
Registry last updated
Jan 24, 2024

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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