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Completed

NCT Number: NCT06452524

Prematurity and Ophthalmological Changes

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

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Key information

Conditions

Retinopathy of Prematurity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Myopia Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Refractive Errors Retinal Diseases Urogenital Diseases

Age range

5 year–13 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara City Hospital Bilkent

Ankara, Turkey (Türkiye)

About this study

Aims: To compare functional (visual acuity and refractive error) and anatomical (biometric values, foveal and choroidal thickness) ophthalmological differences in school-aged children with and without a history of retinopathy of prematurity (ROP).

Settings and Design: Prospective Cross-Sectional Study

Methods and Material: The study was conducted prospectively in the ophthalmology department of Ankara Bilkent City Hospital. Subjects were divided into three groups: 29 children who were treated with laser photocoagulation (ROP-TxGroup), 26 children who developed ROP and did not need treatment (ROP-non-TxGroup), and 25 children who did not develop ROP (Premature Group). The 27 healthy children with a history of full-term born (Control Group), who were in a similar age group for 'control eye examination', were accepted as the control group. A total of 107 patients and 211 eyes were included in the study. Non-cycloplegic and cycloplegic refraction, best corrected visual acuity (BCVA), keratometry, axial length (AL) and anterior chamber depth (ACD), optical coherence tomography (OCT) macular and OCT subfoveal choroidal measurements were performed in all cases.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children with a history of ROP

Exclusion criteria

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

Treatment and study plan

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.

Other names: ROP-Tx Group, ROP-non-Tx Group, Premature Group, Control Group

Primary outcomes

  1. Spherical Equivalents

    Time frame: 4mounth after the procedure

    Dioptre

  2. K1 Flat and K2 Steep

    Time frame: 4mounth after the procedure

    Dioptre

  3. Axial Length

    Time frame: 4mounth after the procedure

    Milimeter

  4. Anterior Chamber Depth

    Time frame: 4mounth after the procedure

    Milimeter

  5. Astigmatism

    Time frame: 4mounth after the procedure

    Dioptre

  6. Best Corrected Visual Acuity

    Time frame: 4mounth after the procedure

    logMAR

  7. Macular and Choroidal Thickness

    Time frame: 4mounth after the procedure

    Micrometer

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

The Precondition of Retinopathy of Prematurity on Visual Acuity, Refraction, Biometric Values, Retinal and Choroidal Thickness in School-Aged Children

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 11, 2024
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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