Prematurity and Ophthalmological Changes

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06452524
• Other study ID #: AKU749K
• Status: Completed
• Start date: September 1, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: June 2024
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: May 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia
• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

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.

Locations

Country	Name	City	State
Turkey	Ankara City Hospital Bilkent	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spherical Equivalents	Dioptre	4mounth after the procedure
Primary	K1 Flat and K2 Steep	Dioptre	4mounth after the procedure
Primary	Axial Length	Milimeter	4mounth after the procedure
Primary	Anterior Chamber Depth	Milimeter	4mounth after the procedure
Primary	Astigmatism	Dioptre	4mounth after the procedure
Primary	Best Corrected Visual Acuity	logMAR	4mounth after the procedure
Primary	Macular and Choroidal Thickness	Micrometer	4mounth after the procedure