Conservative Treatment of Esotropia in Children up to 3 Years Old

Esotropia Clinical Trial

Official title:

Prescription of Full Optical Correction in Refractive Errors to Treat Esotropia in Children up to 3 Years Old

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02404324
• Other study ID #: Treatment of Esotropia
• Status: Active, not recruiting
• Phase: N/A
• First received: December 23, 2014
• Last updated: April 9, 2017
• Start date: January 2012
• Est. completion date: November 2017

Study information

• Verified date: March 2015
• Source: National Centre of Ophthalmology named after academician Zarifa Aliyeva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: November 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Esotropia

Intervention

Other:
• Prescription of spectacles
All children are prescribed full optical correction of refractive errors with special attention to astigmatism up to 0.5 Dptr to achieve maximal clear image on the retina of both eyes.If necessary, direct occlusion or penalization are administered to the children.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Centre of Ophthalmology named after academician Zarifa Aliyeva

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The angle of deviation	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.	2 years