Prematurity and Ophthalmological Changes

NCT06452524 | Completed

• 1 other identifier: AKU749K
• Study Type: observational
• Target: 211
• Locations: 1 country
• Sites: 1

Brief Summary

Ophthalmological differences in school-aged children with and without a history of retinopathy of prematurity

Conditions

Retinopathy of Prematurity; Myopia

Keywords

Biometry; foveal thickness; choroidal thickness; laser photocoagulation; OCT; prematurity; retinopathy of prematurity

Outcome Measures

Primary Outcomes (7)

• Spherical Equivalents

  Dioptre

  4mounth after the procedure

• K1 Flat and K2 Steep

  Dioptre

  4mounth after the procedure

• Axial Length

  Milimeter

  4mounth after the procedure

• Anterior Chamber Depth

  Milimeter

  4mounth after the procedure

• Astigmatism

  Dioptre

  4mounth after the procedure

• Best Corrected Visual Acuity

  logMAR

  4mounth after the procedure

• Macular and Choroidal Thickness

  Micrometer

  4mounth after the procedure

Study Arms (4)

ROP-Tx Group

less than 37 weeks were divided into three groups: 29 children born prematurely who were treated with laser photocoagulation

Device: axial length (AU) and anterior chamber depth (ACD), optical coherence tomography (OCT)

ROP-non-Tx Group

26 children who developed ROP and did not need treatment

Device: axial length (AU) and anterior chamber depth (ACD), optical coherence tomography (OCT)

Premature Group

25 children who did not develop ROP

Device: axial length (AU) and anterior chamber depth (ACD), optical coherence tomography (OCT)

Control Group

27 healthy children with a history of full-term born

Device: axial length (AU) and anterior chamber depth (ACD), optical coherence tomography (OCT)

Interventions

axial length (AU) and anterior chamber depth (ACD), optical coherence tomography (OCT) DEVICE

Non-cycloplegic and cycloplegic refraction, best corrected visual acuity (BCVA), axial length (AU) and anterior chamber depth (ACD), optical coherence tomography (OCT) macular and OCT subfoveal choroidal measurements were performed in all cases.

Also known as: ROP-Tx Group, ROP-non-Tx Group, Premature Group, Control Group

Control Group; Premature Group; ROP-Tx Group; ROP-non-Tx Group

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The files of babies born between 2008 and 2016 and taken for ROP scan in the ophthalmology department were randomly separated by archive scanning. International Classification of Retinopathy of Prematurity (ICROP) was used as classification criteria. Although ICROP was used as screening criteria, every patient suspected by the paediatrician was examined. When the children of the volunteer families reached the age of 5-13, their children were called for examination.

You may qualify if:

• Children with a history of ROP

You may not qualify if:

• Stage 4-5 ROP, Presence of media opacities (such as cataract) Ocular trauma or ocular surgery Hydrocephalus or grade 3 and above intracerebral hemorrhage, Uncooperative children

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital Bilkent

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Retinopathy of Prematurity; Myopia; Premature Birth

Interventions

Tomography, Optical Coherence; Control Groups

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Refractive Errors; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods

Study Officials

• Ali Kutay KILINÇ

  Ankara City Hospital Bilkent

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: June 11, 2024
• Study Start: September 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: May 1, 2022
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

TU (1)