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Prematurity and Ophthalmological Changes

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06452524
Enrollment
211
Registered
2024-06-11
Start date
2021-09-01
Completion date
2022-05-01
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia, Retinopathy of Prematurity

Keywords

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

Brief summary

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

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.

Interventions

DEVICEaxial 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.

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
5 Years to 13 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Spherical Equivalents4mounth after the procedureDioptre
K1 Flat and K2 Steep4mounth after the procedureDioptre
Axial Length4mounth after the procedureMilimeter
Anterior Chamber Depth4mounth after the procedureMilimeter
Astigmatism4mounth after the procedureDioptre
Best Corrected Visual Acuity4mounth after the procedurelogMAR
Macular and Choroidal Thickness4mounth after the procedureMicrometer

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026