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Conservative Treatment of Esotropia in Children up to 3 Years Old

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02404324
Recruitment Status : Unknown
Verified March 2015 by National Centre of Ophthalmology named after academician Zarifa Aliyeva.
Recruitment status was:  Active, not recruiting
First Posted : March 31, 2015
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
National Centre of Ophthalmology named after academician Zarifa Aliyeva

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.

Condition or disease Intervention/treatment Phase
Esotropia Other: Prescription of spectacles Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prescription of Full Optical Correction in Refractive Errors to Treat Esotropia in Children up to 3 Years Old
Study Start Date : January 2012
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. The angle of deviation [ Time Frame: 2 years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02404324


Sponsors and Collaborators
National Centre of Ophthalmology named after academician Zarifa Aliyeva
Investigators
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Study Director: Elmar Kasimov, Professor National Centre of Ophthalmology named after academician Zarifa Aliyeva
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Responsible Party: National Centre of Ophthalmology named after academician Zarifa Aliyeva
ClinicalTrials.gov Identifier: NCT02404324    
Other Study ID Numbers: Treatment of Esotropia
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: March 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Esotropia
Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases