Clinical trial NCT06452524: Prematurity and Ophthalmological Changes
Official title: The Precondition of Retinopathy of Prematurity on Visual Acuity, Refraction, Biometric Values, Retinal and Choroidal Thickness in School-Aged Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinopathy of Prematurity
Myopia
Keywords: Biometry
foveal thickness
choroidal thickness
laser photocoagulation
OCT
prematurity
retinopathy of prematurity
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 211
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Spherical Equivalents
timeFrame: 4mounth after the procedure
measure: K1 Flat and K2 Steep
timeFrame: 4mounth after the procedure
measure: Axial Length
timeFrame: 4mounth after the procedure
measure: Anterior Chamber Depth
timeFrame: 4mounth after the procedure
measure: Astigmatism
timeFrame: 4mounth after the procedure
measure: Best Corrected Visual Acuity
timeFrame: 4mounth after the procedure
measure: Macular and Choroidal Thickness
timeFrame: 4mounth after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital Bilkent
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Ali Kutay KILINÇ
role: STUDY_CHAIR
References: