NCT04429659

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

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

January 2, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2020

Completed
Last Updated

June 12, 2020

Status Verified

June 1, 2020

Enrollment Period

3 months

First QC Date

June 9, 2020

Last Update Submit

June 11, 2020

Conditions

Refractive ErrorsEsotropiaAmblyopia Strabismic

Outcome Measures

Primary Outcomes (2)

  • spherical equivalent

    spherical error plus half of the cylindirical error measured by retinoscopy, diopter

    36 months

  • cylindirical error

    cylindirical error measured by retinoscopy, diopter

    36 months

Study Arms (2)

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

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

study population was composed of amblyopic children with partially refractive ET.

You may qualify if:

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

You may not qualify if:

  • Systemic diseases Neurological disorders and diseases Additional ocular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University Ophthalmology Department

Sakarya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Refractive ErrorsEsotropiaAmblyopia

Condition Hierarchy (Ancestors)

Eye DiseasesStrabismusOcular Motility DisordersCranial Nerve DiseasesNervous System DiseasesBrain DiseasesCentral Nervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Burcin Cakir, MD

    Sakarya University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2020

First Posted

June 12, 2020

Study Start

January 2, 2019

Primary Completion

April 1, 2019

Study Completion

September 25, 2019

Last Updated

June 12, 2020

Record last verified: 2020-06

Locations

TU(1)