Clinical trial NCT03865134: Evaluation of Visual - Motor Development in Children With Retinopathy of Prematurity
Official title: Evaluation of Visual - Motor Integration and Motor Coordination in Children With Retinopathy of Prematurity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Retinopathy
Visual Impairment
Motor Delay
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2019-03-06
Enrollment: 69
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who were followed up and treated in the outpatient clinic of Zeynep Kamil Women and Children Diseases Training and Research Hospital, Ophthalmology Clinic with the diagnosis of Prematurity Retinopathy between the years 2012-2015 were included in the study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Motor Integration
timeFrame: 3 weeks
measure: Visual Perception
timeFrame: 3 weeks
measure: Motor Coordination
timeFrame: 3 weeks
measure: Retinal Layers' Development
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
measure: Quality of Life in Parents
timeFrame: 3 weeks
measure: State - Trait Anxiety of Parents
timeFrame: 3 weeks
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
state: Beykoz
Study officials:
affiliation: Istanbul Medipol University Hospital
name: Zeliha Candan Algun
role: STUDY_DIRECTOR
References:
citation: Rothman AL, Mangalesh S, Chen X, Toth CA. Optical coherence tomography of the preterm eye: from retinopathy of prematurity to brain development. Eye Brain. 2016 May 27;8:123-133. doi: 10.2147/EB.S97660. eCollection 2016.
citation: Kabatas EU, Kurtul BE, Altiaylik Ozer P, Kabatas N. Comparison of Intravitreal Bevacizumab, Intravitreal Ranibizumab and Laser Photocoagulation for Treatment of Type 1 Retinopathy of Prematurity in Turkish Preterm Children. Curr Eye Res. 2017 Jul;42(7):1054-1058. doi: 10.1080/02713683.2016.1264607. Epub 2017 Jan 27.
citation: Araz-Ersan B, Kir N, Tuncer S, Aydinoglu-Candan O, Yildiz-Inec D, Akdogan B, Ekici B, Demirel A, Ozmen M. Preliminary anatomical and neurodevelopmental outcomes of intravitreal bevacizumab as adjunctive treatment for retinopathy of prematurity. Curr Eye Res. 2015 May;40(6):585-91. doi: 10.3109/02713683.2014.941070. Epub 2014 Jul 15.