Conservative Treatment of Esotropia in Children up to 3 Years Old

NCT ID: NCT02404324

Last Updated: 2017-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2017-11-30

Brief Summary

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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

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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.

Conditions

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Esotropia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Prescription of spectacles

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

3 Months

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Centre of Ophthalmology named after academician Zarifa Aliyeva

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elmar Kasimov, Professor

Role: STUDY_DIRECTOR

National Centre of Ophthalmology named after academician Zarifa Aliyeva

Other Identifiers

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Treatment of Esotropia

Identifier Type: -

Identifier Source: org_study_id

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