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Conservative Treatment of Esotropia in Children up to 3 Years Old

Sponsor
National Centre of Ophthalmology named after academician Zarifa Aliyeva (Other)
Overall Status
Unknown status
CT.gov ID
NCT02404324
Collaborator
(none)
150
Enrollment
1
Arm
70
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Prescription of spectacles
 N/A

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 Design

Study Type:
Interventional
Anticipated 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 :
Jan 1, 2012
Anticipated Primary Completion Date :
Oct 1, 2017
Anticipated Study Completion Date :
Nov 1, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. The angle of deviation [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.

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Centre of Ophthalmology named after academician Zarifa Aliyeva
ClinicalTrials.gov Identifier:
NCT02404324
Other Study ID Numbers:
  • Treatment of Esotropia
First Posted:
Mar 31, 2015
Last Update Posted:
Apr 11, 2017
Last Verified:
Mar 1, 2015
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Esotropia

Study Results

No Results Posted as of Apr 11, 2017