NCT02404324

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

April 11, 2017

Status Verified

March 1, 2015

Enrollment Period

5.8 years

First QC Date

December 23, 2014

Last Update Submit

April 9, 2017

Conditions

Esotropia

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 years

Study Arms (1)

spectacles

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

Other: Prescription of spectacles

Interventions

Prescription of spectaclesOTHER

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.

spectacles

Eligibility Criteria

Age3 Months - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • Age above 3 years
  • Patients with neurological diseases and paralytic strabismus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Esotropia

Condition Hierarchy (Ancestors)

StrabismusOcular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye Diseases

Study Officials

  • Elmar Kasimov, Professor

    National Centre of Ophthalmology named after academician Zarifa Aliyeva

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2014

First Posted

March 31, 2015

Study Start

January 1, 2012

Primary Completion

October 1, 2017

Study Completion

November 1, 2017

Last Updated

April 11, 2017

Record last verified: 2015-03

Data Sharing

IPD Sharing
Will not share