Clinical trial NCT06221098: Study of Clinical Types and Treatment Outcomes of Pediatric Esotropia in Sohag University Hospital
Official title: Study of Clinical Types and Treatment Outcomes of Pediatric Esotropia in Sohag University Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infantile Esotropia
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: orthotropia
timeFrame: 6 months
measure: residual esotropia
timeFrame: 6months
measure: consecuative exotropia
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University hospitals
Study officials:
References:
citation: 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.
citation: 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.
citation: von Noorden GK. Bowman lecture. Current concepts of infantile esotropia. Eye (Lond). 1988;2 ( Pt 4):343-57. doi: 10.1038/eye.1988.65.
citation: 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.