Overview

This trial is active, not recruiting.

Condition esotropia
Treatment prescription of spectacles
Sponsor National Centre of Ophthalmology named after academician Zarifa Aliyeva
Start date January 2012
End date September 2015
Trial size 150 participants
Trial identifier NCT02404324, Treatment of Esotropia

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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
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.

Primary Outcomes

Measure
The angle of deviation
time frame: 2 years

Eligibility Criteria

Male or female participants from 3 months up to 3 years old.

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

Additional Information

Official title Prescription of Full Optical Correction in Refractive Errors to Treat Esotropia 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by National Centre of Ophthalmology named after academician Zarifa Aliyeva.