Clinical Trials Directory

Trials / Completed

CompletedNCT06452524

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
Phase
Study type
Observational
Enrollment
211 (actual)
Sponsor
Ankara City Hospital Bilkent · Academic / Other
Sex
All
Age
5 Years – 13 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
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.

Timeline

Start date
2021-09-01
Primary completion
2022-03-01
Completion
2022-05-01
First posted
2024-06-11
Last updated
2024-06-11

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06452524. Inclusion in this directory is not an endorsement.