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

NCT ID: NCT06221098

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2023-10-01

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.

Conditions

Infantile Esotropia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

bilateral medial rectus recession

Intervention Type: PROCEDURE

release muuscle from its original insertion and backword inserted in sclera

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.

Group Type: ACTIVE_COMPARATOR

bilateral medial rectus recession

Intervention Type: PROCEDURE

release muuscle from its original insertion and backword inserted in sclera

non-accommodative esotropia

neither congenital nor accommodative esotropia

Group Type: ACTIVE_COMPARATOR

bilateral medial rectus recession

Intervention Type: PROCEDURE

release muuscle from its original insertion and backword inserted in sclera

Interventions

bilateral medial rectus recession

release muuscle from its original insertion and backword inserted in sclera

Intervention Type: PROCEDURE

Other Intervention Names

Monocular medial rectus (MR) recession and lateral rectus (LR) resection

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.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Abeer Nasser Mazen

resident of ophthalmology department el helal hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag University hospitals

Sohag, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 17765436 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3222041 (View on PubMed)

von Noorden GK. Bowman lecture. Current concepts of infantile esotropia. Eye (Lond). 1988;2 ( Pt 4):343-57. doi: 10.1038/eye.1988.65.

Reference Type: BACKGROUND

PMID: 3075563 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10873987 (View on PubMed)

Other Identifiers

soh-med-22-04-03

Identifier Type: -

Identifier Source: org_study_id