Prematurity and Ophthalmological Changes

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

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

Study Overview

• Status: Completed
• Conditions: Myopia; Retinopathy of Prematurity
• Intervention / Treatment: Device: axial length (AU) and anterior chamber depth (ACD), optical coherence tomography (OCT)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 211

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Ankara City Hospital Bilkent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); 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: Control Group; ROP-Tx Group; ROP-non-Tx Group; Premature Group
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); 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: Control Group; ROP-Tx Group; ROP-non-Tx Group; Premature Group
Premature Group; 25 children who did not develop ROP	Device: axial length (AU) and anterior chamber depth (ACD), optical coherence tomography (OCT); 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: Control Group; ROP-Tx Group; ROP-non-Tx Group; Premature Group
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); 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: Control Group; ROP-Tx Group; ROP-non-Tx Group; Premature Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Study Chair: Ali Kutay KILINÇ, Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: May 24, 2024
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 5, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: OCT; retinopathy of prematurity; prematurity; Biometry; choroidal thickness; foveal thickness; laser photocoagulation
• Additional Relevant MeSH Terms: Eye Diseases; Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Infant, Premature, Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Retinal Diseases; Premature Birth; Retinopathy of Prematurity
• Other Study ID Numbers: AKU749K

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No