Conservative Treatment of Esotropia in Children up to 3 Years Old

Not Applicable

• Conditions: Esotropia
• Interventions: Other: Prescription of spectacles

• Registration Number: NCT02404324
• Lead Sponsor: National Centre of Ophthalmology named after academician Zarifa Aliyeva

Brief Summary

The objective of this prospective study is the treatment of esotropia by prescribing the full precise optical correction of refractive errors in children up to 3 years old.

Detailed Description

This investigation includes children with esotropia associated with hyperopia, hypermetropic astigmatism, myopia, myopic astigmatism and minor ametropias. All children are prescribed full optical correction of refractive errors with special attention to astigmatism up to 0.5 Dpt to achieve maximal clear image on the retina of both eyes.If necessary, direct occlusion or penalization were administered to the children. The investigators suggest that this approach will give good results in the treatment of esotropia.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2014-12-23
• Status Verified: 2015-03
• Study First Submitted QC: 2015-03-26
• Study First Posted: 2015-03-31
• Last Update Submitted: 2017-04-09
• Last Update Posted: 2017-04-11
• Primary Completion: 2017-10
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Within the age of 3 months to 3 years (inclusive infantile esotropia)
• Patients with constant or periodic esotropia and with revealed angle of deviation 5 degrees or over by Hirschberg test
• Patients with refractive errors (inclusive minor ametropias from 0.5 Dptr)

Exclusion Criteria

• Age above 3 years
• Patients with neurological diseases and paralytic strabismus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
spectacles	Prescription of spectacles	Esotropia is treated by full optical correction (spectacles prescription) in all children with refractive errors. Special attention is paid to astigmatism up to 0.5 Dptr. Intervention: Prescription of spectacles

Primary Outcome Measures

Name	Time	Method
The angle of deviation	2 years	The absolute success is defined as restored symmetrical eye position.Qualified success is considered as reduction of the angle of deviation. Patients are examined 24 months later to assess outcome of treatment.