NCT04432181

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
Last Updated

June 17, 2020

Status Verified

June 1, 2020

Enrollment Period

5 months

First QC Date

June 11, 2020

Last Update Submit

June 15, 2020

Conditions

Astigmatism of Both EyesAmblyopiaStrabismus

Outcome Measures

Primary Outcomes (1)

  • ocular deviation

    ocular deviation measured by alternate prism cover test, prism diopter

    24 month

Secondary Outcomes (1)

  • convergence

    24 month

Study Arms (2)

Group 1, astigmatic patients with amblyopia

astigmatic children with amblyopia

Other: ophthalmic examination

Group 2, astigmatic patients without amblyopia

astigmatic children without amblyopia

Other: ophthalmic examination

Interventions

ophthalmic examinationOTHER

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

Group 1, astigmatic patients with amblyopiaGroup 2, astigmatic patients without amblyopia

Eligibility Criteria

Age7 Years - 13 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

children age range between 7 and 13 years with ≥1,75 diopter (D) astigmatism were included. Patients with additional ocular and systemic diseases were excluded in this study. Subjects with and without amblyopia composed group 1 and 2, respectively.

You may qualify if:

  • astigmatisma ≥1,75 Diopter

You may not qualify if:

  • systemic diseases additional ocular diseases neurological diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University Ophthalmology Department

Sakarya, 54000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

AmblyopiaStrabismus

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOcular Motility DisordersCranial Nerve Diseases

Study Officials

  • Burcin Cakir, MD

    Sakarya University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
30 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Burcin Cakir, FICO

Study Record Dates

First Submitted

June 11, 2020

First Posted

June 16, 2020

Study Start

September 4, 2018

Primary Completion

February 1, 2019

Study Completion

February 3, 2020

Last Updated

June 17, 2020

Record last verified: 2020-06

Locations

TU(1)