Brief Summary

The aim of this study was to investigate the eye structure, visual impairment, visual motor development and motor coordination of children between 2-6 ages that had applied to diod laser photocoagulation and intravitreal anti - vascular endothelial growth factor treatment.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P25-P50 for all trials

Timeline

Completed

Started Sep 2018

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

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Study Timeline

Key milestones and dates

7 months study duration

Study Start

First participant enrolled

September 20, 2018

Completed

5 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2019

Completed

5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2019

Completed

19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2019

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2019

Completed

Last Updated

March 16, 2020

Status Verified

February 1, 2019

Enrollment Period

6 months

First QC Date

March 1, 2019

Last Update Submit

March 13, 2020

Conditions

Premature Retinopathy Visual Impairment Motor Delay

Outcome Measures

Primary Outcomes (4)

Visual Motor Integration
Visual-motor integration (VMI) is "the degree to which visual perception and finger-hand movements are well coordinated" and will asses with Beery-Buktenica Developmental Test of Visual-Motor Integration in this study. This test is a standardized, norm-referenced assessment involving copying geometric forms that is used to determine the level of integration between visual and motor systems in people of all ages. The Short Format and Full Format tests take about 10-15 minutes each to administer. Results are reported as standard scores, percentiles, and age equivalents.
3 weeks
Visual Perception
Visual perception will asses with Beery-Buktenica Developmental Test of Visual-Motor Integration in this study. This test is a standardized, norm-referenced assessment involving copying geometric forms that is used to determine the level of integration between visual and motor systems in people of all ages. Visual Perception test takes about 5 minutes. Results are reported as standard scores, percentiles, and age equivalents.
3 weeks
Motor Coordination
Motor Coordination is coordination of finger movements and will asses by Beery-Buktenica Developmental Test of Visual-Motor Integration in this study. This test is a standardized, norm-referenced assessment involving copying geometric forms that is used to determine the level of integration between visual and motor systems in people of all ages. Motor coordination test takes about 5 minutes. Results are reported as standard scores, percentiles, and age equivalents.
3 weeks
Retinal Layers' Development
Development of retinal layers will assess with Optical coherence tomography (OCT). The OCT allows for in vivo, cross-sectional assessment of eye tissue, including the retina and its vasculature. By comparing the interference patterns of light that passes through live tissue to a reference arm, OCT provides high-resolution imaging of just a few microns of eye microanatomy.
3 weeks

Other Outcomes (2)

Quality of Life in Parents
3 weeks
State - Trait Anxiety of Parents
3 weeks

Study Arms (3)

Laser Group

Children with premature retinopathy treated with Laser therapy. All cases are evaluated with Snellen Test, Autorefractometer, Titmus Stereo Fly Test, Optical Kohlerans Tomography, Peabody Developmental Motor Scales - II. Investigation of Visual Motor Integration will evaluate with Beery- Buktenica Developmental Test of Visual Motor Integration and Peabody. Parents are evaluated World Health Organization Quality of Life - BREF and State - Trait Anxiety Inventory.

Diagnostic Test: Snellen TestDiagnostic Test: AutorefractometerDiagnostic Test: Titmus Stereo Fly TestDiagnostic Test: Optical Kohlerans TomographyBehavioral: Investigation of Visual Motor IntegrationBehavioral: Peabody Developmental Motor Scales - IIBehavioral: World Health Organization Quality of Life - BREFBehavioral: State - Trait Anxiety Inventory

Anti-VEGF Group

Children with premature retinopathy treated with anti-VEGF therapy. All cases are evaluated with Snellen Test, Autorefractometer, Titmus Stereo Fly Test, Optical Kohlerans Tomography, Peabody Developmental Motor Scales - II. Investigation of Visual Motor Integration will evaluate with Beery- Buktenica Developmental Test of Visual Motor Integration and Peabody. Parents are evaluated World Health Organization Quality of Life - BREF and State - Trait Anxiety Inventory.

Regrese Group

Children with premature retinopathy haven't applied any invasive treatment method. All cases are evaluated with Snellen Test, Autorefractometer, Titmus Stereo Fly Test, Optical Kohlerans Tomography, Peabody Developmental Motor Scales - II. Investigation of Visual Motor Integration will evaluate with Beery- Buktenica Developmental Test of Visual Motor Integration and Peabody. Parents are evaluated World Health Organization Quality of Life - BREF and State - Trait Anxiety Inventory.