Conservative Treatment of Esotropia in Children up to 3 Years Old

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

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.

Study Overview

• Status: Unknown
• Conditions: Esotropia
• Intervention / Treatment: Other: Prescription of spectacles

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Centre of Ophthalmology named after academician Zarifa Aliyeva
• Investigators: Study Director: Elmar Kasimov, Professor, National Centre of Ophthalmology named after academician Zarifa Aliyeva

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: December 23, 2014
• First Submitted That Met QC Criteria: March 26, 2015
• First Posted (Estimate): March 31, 2015

Study Record Updates

• Last Update Posted (Actual): April 11, 2017
• Last Update Submitted That Met QC Criteria: April 9, 2017
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Ocular Motility Disorders; Strabismus; Esotropia
• Other Study ID Numbers: Treatment of Esotropia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO