Prematurity and Ophthalmological Changes

NCT ID: NCT06452524

Last Updated: 2024-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

211 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-05-01

Brief Summary

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

Detailed Description

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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

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Retinopathy of Prematurity Myopia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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ROP-Tx Group

less than 37 weeks were divided into three groups: 29 children born prematurely who were treated with laser photocoagulation

axial length (AU) and anterior chamber depth (ACD), optical coherence tomography (OCT)

Intervention Type DEVICE

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.

ROP-non-Tx Group

26 children who developed ROP and did not need treatment

axial length (AU) and anterior chamber depth (ACD), optical coherence tomography (OCT)

Intervention Type DEVICE

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.

Premature Group

25 children who did not develop ROP

axial length (AU) and anterior chamber depth (ACD), optical coherence tomography (OCT)

Intervention Type DEVICE

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.

Control Group

27 healthy children with a history of full-term born

axial length (AU) and anterior chamber depth (ACD), optical coherence tomography (OCT)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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ROP-Tx Group ROP-non-Tx Group Premature Group Control Group

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Ali Kutay KILINÇ

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ali Kutay KILINÇ

Role: STUDY_CHAIR

Ankara City Hospital Bilkent

Locations

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Ankara City Hospital Bilkent

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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AKU749K

Identifier Type: -

Identifier Source: org_study_id

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