Prematurity and Ophthalmological Changes

Completed

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

• Registration Number: NCT06452524
• Lead Sponsor: Ankara City Hospital Bilkent

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.

Study Timeline

• Study Start: 2021-09-01
• Primary Completion: 2022-03-01
• Study Completion: 2022-05-01
• Study First Submitted: 2024-05-24
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-05
• Last Update Submitted: 2024-06-05
• Study First Posted: 2024-06-11
• Last Update Posted: 2024-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ROP-Tx Group	axial length (AU) and anterior chamber depth (ACD), optical coherence tomography (OCT)	less than 37 weeks were divided into three groups: 29 children born prematurely who were treated with laser photocoagulation
ROP-non-Tx Group	axial length (AU) and anterior chamber depth (ACD), optical coherence tomography (OCT)	26 children who developed ROP and did not need treatment
Premature Group	axial length (AU) and anterior chamber depth (ACD), optical coherence tomography (OCT)	25 children who did not develop ROP
Control Group	axial length (AU) and anterior chamber depth (ACD), optical coherence tomography (OCT)	27 healthy children with a history of full-term born

Primary Outcome Measures

Name	Time	Method
Anterior Chamber Depth	4mounth after the procedure	Milimeter
K1 Flat and K2 Steep	4mounth after the procedure	Dioptre
Axial Length	4mounth after the procedure	Milimeter
Astigmatism	4mounth after the procedure	Dioptre
Best Corrected Visual Acuity	4mounth after the procedure	logMAR
Spherical Equivalents	4mounth after the procedure	Dioptre
Macular and Choroidal Thickness	4mounth after the procedure	Micrometer

Trial Locations

Locations (1)

Ankara City Hospital Bilkent; 🇹🇷 Ankara, Turkey