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

S

Sohag University

Status

Completed

Conditions

Infantile Esotropia

Treatments

Procedure: bilateral medial rectus recession

Study type

Interventional

Funder types

Other

Identifiers

NCT06221098
soh-med-22-04-03

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

1 day to 12 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 3 patient groups

congenital esotropia
Active Comparator group
Description:
will be defined as that type of esotropia with an onset prior to 6 months of age & characterized by a large stable angle
Treatment:
Procedure: bilateral medial rectus recession
accommodative esotropia
Active Comparator group
Description:
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.
Treatment:
Procedure: bilateral medial rectus recession
non-accommodative esotropia
Active Comparator group
Description:
neither congenital nor accommodative esotropia
Treatment:
Procedure: bilateral medial rectus recession

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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