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Conservative Treatment of Esotropia in Children up to 3 Years Old

Primary Purpose

Esotropia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Prescription of spectacles
Sponsored by
National Centre of Ophthalmology named after academician Zarifa Aliyeva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esotropia

Eligibility Criteria

3 Months - 3 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    spectacles

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 23, 2014
    Last Updated
    April 9, 2017
    Sponsor
    National Centre of Ophthalmology named after academician Zarifa Aliyeva
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02404324
    Brief Title
    Conservative Treatment of Esotropia in Children up to 3 Years Old
    Official Title
    Prescription of Full Optical Correction in Refractive Errors to Treat Esotropia in Children up to 3 Years Old
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    October 2017 (Anticipated)
    Study Completion Date
    November 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Centre of Ophthalmology named after academician Zarifa Aliyeva

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Esotropia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    spectacles
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Prescription of spectacles
    Intervention Description
    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 Outcome Measure Information:
    Title
    The angle of deviation
    Description
    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.
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Months
    Maximum Age & Unit of Time
    3 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elmar Kasimov, Professor
    Organizational Affiliation
    National Centre of Ophthalmology named after academician Zarifa Aliyeva
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Conservative Treatment of Esotropia in Children up to 3 Years Old

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