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NCT04429659 Clinical Trial

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

Refractive Errors Clinical Trial

Official title:
Changes in Refractive Error in Patients With Both Partially Refractive Esotropia and Amblyopia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04429659
Other study ID # Sakarya strabismus
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2, 2019
Est. completion date September 25, 2019

Study information
Verified date June 2020
Source Sakarya University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 58
Est. completion date September 25, 2019
Est. primary completion date April 1, 2019
Accepts healthy volunteers No
Gender All
Age group 6 Years to 15 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Turkey Sakarya University Ophthalmology Department Sakarya

Sponsors (1)
Lead Sponsor Collaborator
Sakarya University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary spherical equivalent spherical error plus half of the cylindirical error measured by retinoscopy, diopter 36 months
Primary cylindirical error cylindirical error measured by retinoscopy, diopter 36 months
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