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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04432181
Other study ID # sakarya amblyopia
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 4, 2018
Est. completion date February 3, 2020

Study information

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

Clinical Trial Summary

the records of astigmatic children were reviewed and any deviation was investigated at near and distance. refractive errors, stereopsis, convergence insufficiency were also evaluated. children were divided into two groups according to the presence of amblyopia and ocular deviations and other parameters were compared between groups.


Description:

The aim of the study was to evaluate deviations in children with ≥1,75 diopter (D) astigmatism with or without amblyopia.

The records of children with ≥1,75 D astigmatism were investigated. Subjects with and without amblyopia composed group 1 and 2, respectively. The mean age, gender, amount and type of deviation, presence of convergence insufficiency (CI), stereopsis, time of initial spectacle use and follow-up time, differences in best corrected visual acuity (VoD) and spherical equivalent (SE) between eyes were noted and compared between the groups. Best corrected visual acuity (BCVA), mean SE, astigmatism measurements were also noted and compared between amblyopic, fellow and non-amblyopic eyes.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date February 3, 2020
Est. primary completion date February 1, 2019
Accepts healthy volunteers
Gender All
Age group 7 Years to 13 Years
Eligibility Inclusion Criteria:

- astigmatisma =1,75 Diopter

Exclusion Criteria:

- systemic diseases additional ocular diseases neurological diseases

Study Design


Related Conditions & MeSH terms


Intervention

Other:
ophthalmic examination
ophthalmic examination including; best corrected visual acuity, alternating prism cover test, retinoscopy, fundus examination, ocular vergence evaluation

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 ocular deviation ocular deviation measured by alternate prism cover test, prism diopter 24 month
Secondary convergence presence of convergence insufficiency at 10 cm far from visual axe. 24 month
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