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

Infantile Esotropia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06221098
• Other study ID #: soh-med-22-04-03
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: January 2024
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esotropia
• Infantile Esotropia

Intervention

Procedure:
• bilateral medial rectus recession
release muuscle from its original insertion and backword inserted in sclera

Locations

Country	Name	City	State
Egypt	Sohag University hospitals	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	orthotropia	eye alignment	6 months
Primary	residual esotropia	esotropia >10PD undercorrection	6months
Primary	consecuative exotropia	exotropia > 10PD overcorrection	6 months