Evaluation of Visual - Motor Development in Children With Retinopathy of Prematurity

Completed

• Conditions: Visual Impairment; Premature Retinopathy; Motor Delay
• Interventions: Diagnostic Test: Snellen Test; Diagnostic Test: Autorefractometer; Diagnostic Test: Titmus Stereo Fly Test; Diagnostic Test: Optical Kohlerans Tomography; Behavioral: Investigation of Visual Motor Integration; Behavioral: Peabody Developmental Motor Scales - II; Behavioral: World Health Organization Quality of Life - BREF; Behavioral: State - Trait Anxiety Inventory

• Registration Number: NCT03865134
• Lead Sponsor: Istanbul Medipol University Hospital

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.

Detailed Description

There are three different groups in this study. Children between 2-6 ages that had applied to diod laser photocoagulation and intravitreal anti - vascular endothelial growth factor treatment will have evaluated with Snellen Test, Titmus Fly Test, Optical Kohlerans Tomography, Beery-Buktenica Developmental Test of Visual Motor Integration, Peabody Developmental Motor Scales-II, World Health Organization Quality of Life - BREF and State - Trait Anxiety Inventory.

Study Timeline

• Study Start: 2018-09-20
• Status Verified: 2019-02
• Study First Submitted: 2019-03-01
• Study First Submitted QC: 2019-03-05
• Study First Posted: 2019-03-06
• Primary Completion: 2019-03-25
• Study Completion: 2019-04-25
• Last Update Submitted: 2020-03-13
• Last Update Posted: 2020-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• Age range between 2-6 years of age
• Gestational age range 26-34. be between weeks
• To be diagnosed with retinopathy of prematurity
• Neurological, hereditary and not having metabolic disease
• Compliance with visual examinations and physiotherapy evaluations
• To be children and parents who agree to participate in the study

Exclusion Criteria

• To be a child who does not comply with Optical Kohlerans Tomography (OCT)
• Not participating in one or more of the eye examination or physiotherapy assessments
• Being children and parents who do not agree to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anti-VEGF Group	Snellen Test	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.
Laser Group	State - Trait Anxiety Inventory	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.
Laser Group	Investigation of Visual Motor Integration	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.
Anti-VEGF Group	Titmus Stereo Fly Test	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.
Anti-VEGF Group	World Health Organization Quality of Life - BREF	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	Snellen Test	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.
Laser Group	Snellen Test	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.
Laser Group	Autorefractometer	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.
Laser Group	Optical Kohlerans Tomography	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.
Laser Group	World Health Organization Quality of Life - BREF	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.
Anti-VEGF Group	Optical Kohlerans Tomography	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.
Anti-VEGF Group	Autorefractometer	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.
Anti-VEGF Group	State - Trait Anxiety Inventory	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.
Laser Group	Titmus Stereo Fly Test	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.
Laser Group	Peabody Developmental Motor Scales - II	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.
Anti-VEGF Group	Peabody Developmental Motor Scales - II	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.
Anti-VEGF Group	Investigation of Visual Motor Integration	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	Autorefractometer	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.
Regrese Group	State - Trait Anxiety Inventory	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.
Regrese Group	Titmus Stereo Fly Test	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.
Regrese Group	Investigation of Visual Motor Integration	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.
Regrese Group	Optical Kohlerans Tomography	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.
Regrese Group	Peabody Developmental Motor Scales - II	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.
Regrese Group	World Health Organization Quality of Life - BREF	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.

Primary Outcome Measures

Name	Time	Method
Visual Motor Integration	3 weeks	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.
Visual Perception	3 weeks	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.
Motor Coordination	3 weeks	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.
Retinal Layers' Development	3 weeks	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.

Trial Locations

Locations (1)

Istanbul Medipol University; 🇹🇷 Istanbul, Beykoz, Turkey