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Changes in Refractive Error in Patients With Both Partially Refractive Esotropia and Amblyopia

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: NCT04429659
Recruitment Status : Completed
First Posted : June 12, 2020
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
Sakarya University

Brief Summary:
To investigate changes in refractive errors and evaluate clinical outcomes of strabismus surgery in patients with both amblyopia and partially refractive esotropia (PAET).Amblyopic patients with PAET were enrolled. Non-amblyopic patients with full refractive accommodative esotropia (RAET) were included in the study as a control group. Preoperative and postoperative best corrected visual acuity (BCVA), spherical equivalent (SE), astigmatism, stereoacuity and deviations at near and distance were evaluated and statistically compared in the patient group. The mean BCVA, SE, astigmatism were compared between the patient and the control groups.

Condition or disease
Refractive Errors Esotropia Amblyopia Strabismic

Detailed Description:

Purpose: To investigate changes in refractive errors and evaluate clinical outcomes of strabismus surgery in patients with both amblyopia and partially refractive esotropia (PAET).

Material-Method: Amblyopic patients with PAET were enrolled. Non-amblyopic patients with full refractive accommodative esotropia (RAET) were included in the study as a control group. Preoperative and postoperative best corrected visual acuity (BCVA), spherical equivalent (SE), astigmatism, stereoacuity and deviations at near and distance were evaluated and statistically compared in the patient group. The mean BCVA, SE, astigmatism were compared between the patient and the control groups.

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Study Type : Observational
Actual Enrollment : 58 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Changes in Refractive Error in Patients With Both Partially Refractive Esotropia and Amblyopia
Actual Study Start Date : January 2, 2019
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : September 25, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
Group 1, patients with amblyopia and partially refractive ET
children with both amblyopia and partially refractive accommodative esotropia
Group 2, patients with refractive ET
children with refractive esotropia



Primary Outcome Measures :
  1. spherical equivalent [ Time Frame: 36 months ]
    spherical error plus half of the cylindirical error measured by retinoscopy, diopter

  2. cylindirical error [ Time Frame: 36 months ]
    cylindirical error measured by retinoscopy, diopter



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
study population was composed of amblyopic children with partially refractive ET.
Criteria

Inclusion Criteria:

amblyopic children with partially refractive accommodative esotropia as study group non- amblyopic children with fully refractive accommodative esotropia as control group

-

Exclusion Criteria:

Systemic diseases Neurological disorders and diseases Additional ocular diseases


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): NCT04429659


Locations
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Turkey
Sakarya University Ophthalmology Department
Sakarya, Turkey
Sponsors and Collaborators
Sakarya University
Investigators
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Study Chair: Burcin Cakir, MD Sakarya University
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Responsible Party: Sakarya University
ClinicalTrials.gov Identifier: NCT04429659    
Other Study ID Numbers: Sakarya strabismus
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Amblyopia
Esotropia
Refractive Errors
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases