Retinopathy of PrematurityNCT06452524
Prematurity and Ophthalmological Changes
An observational study of Retinopathy of Prematurity and Myopia, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Ophthalmological differences in school-aged children with and without a history of retinopathy of prematurity Read more about this study
- Who is it for?
- Ages 5 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Retinopathy of Prematurity, Myopia
- What is being tested?
- axial length (AU) and anterior chamber depth (ACD), optical coherence tomography (OCT)
- Type of treatment
- Medical device
- How many people
- 211 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 1 May 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Children with a history of ROP
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Precondition of Retinopathy of Prematurity on Visual Acuity, Refraction, Biometric Values, Retinal and Choroidal Thickness in School-Aged Children
Ophthalmological differences in school-aged children with and without a history of retinopathy of prematurity
Read the 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
- Retinopathy of Prematurity, Myopia
- Being tested
- axial length (AU) and anterior chamber depth (ACD), optical coherence tomography (OCT)
- Keywords
- Biometry, foveal thickness, choroidal thickness, laser photocoagulation, OCT, prematurity, retinopathy of prematurity
- Medical subject headings
- Retinopathy of Prematurity, Myopia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
axial length (AU) and anterior chamber depth (ACD), optical coherence tomography (OCT)Device
Also called ROP-Tx Group, ROP-non-Tx Group, Premature Group, Control Group
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.
| Study group | Role | What they receive |
|---|---|---|
| ROP-Tx Group | less than 37 weeks were divided into three groups: 29 children born prematurely who were treated with laser photocoagulation Receives: Device: axial length (AU) and anterior chamber depth (ACD), optical coherence tomography (OCT) | |
| ROP-non-Tx Group | 26 children who developed ROP and did not need treatment Receives: Device: axial length (AU) and anterior chamber depth (ACD), optical coherence tomography (OCT) | |
| Premature Group | 25 children who did not develop ROP Receives: Device: axial length (AU) and anterior chamber depth (ACD), optical coherence tomography (OCT) | |
| Control Group | 27 healthy children with a history of full-term born Receives: Device: axial length (AU) and anterior chamber depth (ACD), optical coherence tomography (OCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spherical Equivalents
Dioptre
Measured: 4mounth after the procedure
K1 Flat and K2 Steep
Dioptre
Measured: 4mounth after the procedure
Axial Length
Milimeter
Measured: 4mounth after the procedure
Anterior Chamber Depth
Milimeter
Measured: 4mounth after the procedure
Astigmatism
Dioptre
Measured: 4mounth after the procedure
Best Corrected Visual Acuity
logMAR
Measured: 4mounth after the procedure
Macular and Choroidal Thickness
Micrometer
Measured: 4mounth after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Sep 2021
- Primary completion1 Mar 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 211 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Kutay KILINÇ, Ankara City Hospital Bilkent
- Investigators
- Ali Kutay KILINÇ, Study chair, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452524
- Sponsor's protocol ID
- AKU749K
- Status last verified
- Jun 2024
- First submitted
- 24 May 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Precondition of Retinopathy of Prematurity on Visual Acuity, Refraction, Biometric Values, Retinal and Choroidal Thickness in School-Aged Children
- ClinicalTrials.gov ID
- NCT06452524
- Acronym / sponsor ID
- AKU749K
- Conditions
- Retinopathy of Prematurity, Myopia
- Keywords
- Biometry, foveal thickness, choroidal thickness, laser photocoagulation, OCT, prematurity, retinopathy of prematurity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ROP-Tx Group | – | Device: 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 | – | Device: axial length (AU) and anterior chamber depth (ACD), optical coherence tomography (OCT)26 children who developed ROP and did not need treatment |
| Premature Group | – | Device: axial length (AU) and anterior chamber depth (ACD), optical coherence tomography (OCT)25 children who did not develop ROP |
| Control Group | – | Device: axial length (AU) and anterior chamber depth (ACD), optical coherence tomography (OCT)27 healthy children with a history of full-term born |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Children with a history of ROP
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| axial length (AU) and anterior chamber depth (ACD), optical coherence tomography (OCT)Also: ROP-Tx Group, ROP-non-Tx Group, Premature Group, Control GroupNon-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. | Device | Control Group, Premature Group, ROP-Tx Group, ROP-non-Tx Group |
Primary outcome
Spherical Equivalents
Time frame: 4mounth after the procedure
Dioptre
K1 Flat and K2 Steep
Time frame: 4mounth after the procedure
Dioptre
Axial Length
Time frame: 4mounth after the procedure
Milimeter
Anterior Chamber Depth
Time frame: 4mounth after the procedure
Milimeter
Astigmatism
Time frame: 4mounth after the procedure
Dioptre
Best Corrected Visual Acuity
Time frame: 4mounth after the procedure
logMAR
Macular and Choroidal Thickness
Time frame: 4mounth after the procedure
Micrometer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Kutay KILINÇ study chair
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinopathy of Prematurity and Myopia, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spherical Equivalents (time frame: 4mounth after the procedure). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.