Macula AbnormalityNCT03438903
Comparison of Repeatability Between SS and SD-OCT for Measuring Retinal Thickness in Various Retinal Diseases
An observational study of Macula Abnormality, run by Hanyang University at 1 site in South Korea.
Trial summary
Comparison of intradevice repeatability of thickness measurements for macular area in the eyes with normal and various retinal diseases using SS-OCT and SD-OCT Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Macula Abnormality
- What is being tested?
- Repeat exams of OCT device
- Type of treatment
- Medical device
- How many people
- 114 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2017to 31 Jan 2018
- 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 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: normal control : 36 eyes of 36 subjects retinal disease group: 78 eyes of 78 patients
Who may be able to join
- Age-matched normal group was composed of subjects with age over at least 19 years,
- a best-corrected visual acuity of 20/25 or higher,
- normal fundus and intraocular pressure (IOP) < 21mm Hg.
Who cannot join
- an spherical equivalent (SE) larger than ± 6 D,
- cataract graded as more severe than grade 3 (Lens Opacities Classification System III),
- a history of glaucoma and optic nerve diseases, or a history of vitrectomy.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, 11923
About this study
Official title: Comparison of Repeatability Between Swept-source and Spectral-domain Optical Coherence Tomography for Measuring Inner Retinal Thickness in Various Retinal Diseases
Comparison of intradevice repeatability of thickness measurements for macular area in the eyes with normal and various retinal diseases using SS-OCT and SD-OCT
Read the detailed description
The investigators studied the intradevice repeatability of thickness measurements for total retina, retinal nerve fiber layer (RNFL) and ganglion cell-inner plexiform (GC-IPL) layers of macular area in the eyes with normal and various retinal diseases using SS-OCT and SD-OCT and compared the repeatability between two devices.
- Conditions
- Macula Abnormality
- Being tested
- Repeat exams of OCT device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeat exams of OCT deviceDevice
All 2 consecutive OCT examinations were performed by 1 experienced technician, in the order of SD-OCT and SS-OCT. The interval was 10 minutes between examinations by each OCT devices
| Study group | Role | What they receive |
|---|---|---|
| Normal group | Healthy subjects without any ocular problems Repeat exams of OCT device (SD and SS-OCT) Receives: Device: Repeat exams of OCT device | |
| Retinal diseases group | Patients with various macular diseases Repeat exams of OCT device (SD and SS-OCT) Receives: Device: Repeat exams of OCT device |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare repeatability between swept-source optical coherence tomography (SS-OCT) and spectral-domain OCT (SD-OCT) devices for the measurement of retinal thickness in various retinal diseases.
Comparison of Intraclass correlation coefficient (ICC) and coefficients of variability (CV) between devices
Measured: Each device was examined twice consecutively within one minutes. After one OCT device exam, another OCT exam was performed immediately. The interval between test devices did not exceed 5 minutes.
Secondary outcomes (1)
To compare repeatability according to the degree of macular thickness
To compare the repeatability of retinal thickness according to central macular thickness in eyes with retinal diseases
Measured: Each device was examined twice consecutively within one minutes. After one OCT device exam, another OCT exam was performed immediately. The interval between test devices did not exceed 5 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start1 Oct 2017
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macula AbnormalityStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanyang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong Un shin, Hanyang University
- Investigators
- Mincheol Seong, MD, PhD, Study chair, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438903
- Sponsor's protocol ID
- 2017-10-013
- Status last verified
- Feb 2018
- First submitted
- 12 Feb 2018
- Last updated
- 20 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Repeatability Between Swept-source and Spectral-domain Optical Coherence Tomography for Measuring Inner Retinal Thickness in Various Retinal Diseases
- ClinicalTrials.gov ID
- NCT03438903
- Acronym / sponsor ID
- 2017-10-013
- Conditions
- Macula Abnormality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Hanyang UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 20 Feb 2018 (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.
Comparison of intradevice repeatability of thickness measurements for macular area in the eyes with normal and various retinal diseases using SS-OCT and SD-OCT
Detailed description
The investigators studied the intradevice repeatability of thickness measurements for total retina, retinal nerve fiber layer (RNFL) and ganglion cell-inner plexiform (GC-IPL) layers of macular area in the eyes with normal and various retinal diseases using SS-OCT and SD-OCT and compared the repeatability between two devices.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal group | – | Device: Repeat exams of OCT deviceHealthy subjects without any ocular problems Repeat exams of OCT device (SD and SS-OCT) |
| Retinal diseases group | – | Device: Repeat exams of OCT devicePatients with various macular diseases Repeat exams of OCT device (SD and SS-OCT) |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- normal control : 36 eyes of 36 subjects retinal disease group: 78 eyes of 78 patients
Key inclusion criteria (3 listed)
- Age-matched normal group was composed of subjects with age over at least 19 years,
- a best-corrected visual acuity of 20/25 or higher,
- normal fundus and intraocular pressure (IOP) < 21mm Hg.
Key exclusion criteria (3 listed)
- an spherical equivalent (SE) larger than ± 6 D,
- cataract graded as more severe than grade 3 (Lens Opacities Classification System III),
- a history of glaucoma and optic nerve diseases, or a history of vitrectomy.
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 |
|---|---|---|
| Repeat exams of OCT deviceAll 2 consecutive OCT examinations were performed by 1 experienced technician, in the order of SD-OCT and SS-OCT. The interval was 10 minutes between examinations by each OCT devices | Device | Normal group, Retinal diseases group |
Primary outcome
To compare repeatability between swept-source optical coherence tomography (SS-OCT) and spectral-domain OCT (SD-OCT) devices for the measurement of retinal thickness in various retinal diseases.
Time frame: Each device was examined twice consecutively within one minutes. After one OCT device exam, another OCT exam was performed immediately. The interval between test devices did not exceed 5 minutes.
Comparison of Intraclass correlation coefficient (ICC) and coefficients of variability (CV) between devices
1 secondary outcome
To compare repeatability according to the degree of macular thickness
Time frame: Each device was examined twice consecutively within one minutes. After one OCT device exam, another OCT exam was performed immediately. The interval between test devices did not exceed 5 minutes.
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 20 Feb 2018.
Related trials for Macula Abnormality
Not yet recruitingPhase 2/3
Evaluating Efficacy and Safety of Oral Melatonin in Acute Central Serous Chorioretinopathy
Central Serous Chorioretinopathy, Melatonin
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.
Mincheol Seong, MD, PhD study chair
Hanyang University
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 Macula Abnormality, run by Hanyang University at 1 site in South Korea.
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 3 inclusion and 3 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 20 Feb 2018. 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 South Korea. 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?
To compare repeatability between swept-source optical coherence tomography (SS-OCT) and spectral-domain OCT (SD-OCT) devices for the measurement of retinal thickness in various retinal diseases. (time frame: Each device was examined twice consecutively within one minutes. After one OCT device exam, another OCT exam was performed immediately. The interval between test devices did not exceed 5 minutes.). 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 20 Feb 2018; AzTrials last refreshed its copy on 31 Oct 2026.