Eye DiseasesNCT05565547
Multimodal Equipment for Teleophthalmology Assessment (META)
An observational study of Eye Diseases, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
Trial summary
We have developed a Multimodal Equipment for Teleophthalmology Assessment (META) device. This novel device is compact, portable and suitable for packaging and express delivery. With this device, there is a potential to implement a new concept of "hospital-at-home" eye care model. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eye Diseases
- What is being tested?
- META and Commercial devices
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2022to 31 May 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants with healthy eyes or with common eye diseases.
Who may be able to join
- 18 years of age and older.
- Participants with healthy eyes, or patients diagnosed with one or more common eye diseases, including anterior segment eye diseases (conjunctivitis, keratitis, corneal opacity or cataract), fundus diseases (age-related macular degeneration or diabetic retinopathy) and/or refractive error (myopia, high myopia, hyperopia, anisometropia, or presbyopia).
- Willing and able to participate in all examinations related to this study
- Visual acuity of 20/400 or better in the study eye(s).
Who cannot join
- Ocular trauma or postoperative eyes within 3 months.
- Study eye(s) with dilated pupil.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Validation Study for Multimodal Equipment for Teleophthalmology Assessment (META) Device
We have developed a Multimodal Equipment for Teleophthalmology Assessment (META) device. This novel device is compact, portable and suitable for packaging and express delivery. With this device, there is a potential to implement a new concept of "hospital-at-home" eye care model. The present study is designed to validate the META device for future clinical usage and investigation. We will compare the performance of the META device with those provided by commercial devices in terms of image quality of optical coherence tomography (OCT), anterior segment and fundus camera, and evaluate the level of agreement in lesion detection and quantitative measurements between META and other commercial devices (e.g., Heidelberg Spectralis OCT, Haag-Streit BQ900 Slit-lamp imaging, Canon CR-2 fundus imaging, Zeiss IOL Master 500).
Read the detailed description
The META is an innovative and non-invasive examination instrument for a variety of common eye diseases. The integrated multimodality device combines digital slit lamp, fundus camera, OCT, refractometer, optical biometry and visual acuity test (near and distance) that facilitate a comprehensive ophthalmic examination. In the current study, all participants will undergo the measurements provided by the META and by traditional examination modalities (including digital slit lamp, fundus camera, OCT, refractometer, optical biometry and visual acuity test) in a random order. The participants will need to complete several questionnaires to investigate their preference and confidence to receive the META exams in the future.
- Conditions
- Eye Diseases
- Being tested
- META, Commercial devices
- Medical subject headings
- Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
METADevice
The META device is used for a comprehensive ophthalmic examination.
Commercial devicesDevice
Commercial devices (including near and far eye charts, refractometer, optical biometry, slit lamp microscopy, fundus camera and OCT) are used for a comprehensive ophthalmic examination.
| Study group | Role | What they receive |
|---|---|---|
| Patients with common eye diseases | Patients who have common eye diseases, including common anterior segment eye diseases (conjunctivitis, keratitis, corneal opacity, cataract) and fundus diseases (age-related macular degeneration, diabetic retinopathy) and refractive error (myopia, high myopia, hyperopia, anisometropia and presbyopia). Receives: Device: META; Device: Commercial devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image Quality
To evaluate the image quality of the META versus commercial devices. These images include slit-lamp anterior-segment images, colour fundus photographs, and OCT scans. The image quality metrics (e.g., position, focus, contrast, etc.) will be identified by masked qualified ophthalmologists independently and scored according to the same grading scheme
Measured: in the same 1 day
Level of agreement in quantitative measurements provided by META-OCT and by commercial OCT
OCT images will be captured by META-OCT and by a commercial OCT, and segmented and analyzed with default algorithm to yield quantitative measurements.
Measured: in the same 1 day
Secondary outcomes (8)
Level of agreement in axial length measurement
Accuracy of axial length measurement will be captured by META-AL versus by a commercial biometric device.
Measured: in the same 1 day
Level of agreement in spherical equivalent diopter (SED) and astigmatism vector components (J0 and J45)
Accuracy of SED and J0 and J45 will be obtained by META-SE versus by a commercial refractor.
Measured: in the same 1 day
Level of agreement in near and far visual acuity measurements
Accuracy of near and far visual acuity measurements will be obtained by META-VA versus by reference ETDRS charts.
Measured: in the same 1 day
Level of agreement in detecting ocular abnormalities.
Agreement in the detection of ocular abnormalities (e.g., corneal scars, keratic precipitates, lens opacification, macular fluid, or other retinopathy) by META images versus by commercial imaging devices.
Measured: in the same 1 day
Repeatability in quantitative measurements provided by META-OCT
OCT images will be captured by META-OCT twice, and the repeatability of quantitative measurements will be assessed.
Measured: in the same 1 day
Exam success rate
The exam success rate will be obtained by META versus by commercial devices.
Measured: in the same 1 day
Time spent on the examinations
The time spent on the examinations will be obtained by META versus by commercial devices.
Measured: in the same 1 day
Patient experience
Investigator-administered questionnaires will be used to investigate participants' preferences and confidence to receive META exams in the future.
Measured: in the same 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start15 Oct 2022 (estimated)
- Primary completion31 Mar 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseasesStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yizhi Liu, M.D., Ph.D., Study chair, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565547
- Sponsor's protocol ID
- IIT2022123
- Status last verified
- Sep 2022
- First submitted
- 30 Sep 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation Study for Multimodal Equipment for Teleophthalmology Assessment (META) Device
- ClinicalTrials.gov ID
- NCT05565547
- Acronym / sponsor ID
- IIT2022123
- Conditions
- Eye Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Oct 2022 (estimated)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 4 Oct 2022 (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.
We have developed a Multimodal Equipment for Teleophthalmology Assessment (META) device. This novel device is compact, portable and suitable for packaging and express delivery. With this device, there is a potential to implement a new concept of "hospital-at-home" eye care model. The present study is designed to validate the META device for future clinical usage and investigation. We will compare the performance of the META device with those provided by commercial devices in terms of image quality of optical coherence tomography (OCT), anterior segment and fundus camera, and evaluate the level of agreement in lesion detection and quantitative measurements between META and other commercial devices (e.g., Heidelberg Spectralis OCT, Haag-Streit BQ900 Slit-lamp imaging, Canon CR-2 fundus imaging, Zeiss IOL Master 500).
Detailed description
The META is an innovative and non-invasive examination instrument for a variety of common eye diseases. The integrated multimodality device combines digital slit lamp, fundus camera, OCT, refractometer, optical biometry and visual acuity test (near and distance) that facilitate a comprehensive ophthalmic examination. In the current study, all participants will undergo the measurements provided by the META and by traditional examination modalities (including digital slit lamp, fundus camera, OCT, refractometer, optical biometry and visual acuity test) in a random order. The participants will need to complete several questionnaires to investigate their preference and confidence to receive the META exams in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with common eye diseases | – | Device: META, Device: Commercial devicesPatients who have common eye diseases, including common anterior segment eye diseases (conjunctivitis, keratitis, corneal opacity, cataract) and fundus diseases (age-related macular degeneration, diabetic retinopathy) and refractive error (myopia, high myopia, hyperopia, anisometropia and presbyopia). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with healthy eyes or with common eye diseases.
Key inclusion criteria (4 listed)
- 18 years of age and older.
- Participants with healthy eyes, or patients diagnosed with one or more common eye diseases, including anterior segment eye diseases (conjunctivitis, keratitis, corneal opacity or cataract), fundus diseases (age-related macular degeneration or diabetic retinopathy) and/or refractive error (myopia, high myopia, hyperopia, anisometropia, or presbyopia).
- Willing and able to participate in all examinations related to this study
- Visual acuity of 20/400 or better in the study eye(s).
Key exclusion criteria (2 listed)
- Ocular trauma or postoperative eyes within 3 months.
- Study eye(s) with dilated pupil.
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 |
|---|---|---|
| METAThe META device is used for a comprehensive ophthalmic examination. | Device | Patients with common eye diseases |
| Commercial devicesCommercial devices (including near and far eye charts, refractometer, optical biometry, slit lamp microscopy, fundus camera and OCT) are used for a comprehensive ophthalmic examination. | Device | Patients with common eye diseases |
Primary outcome
Image Quality
Time frame: in the same 1 day
To evaluate the image quality of the META versus commercial devices. These images include slit-lamp anterior-segment images, colour fundus photographs, and OCT scans. The image quality metrics (e.g., position, focus, contrast, etc.) will be identified by masked qualified ophthalmologists independently and scored according to the same grading scheme
Level of agreement in quantitative measurements provided by META-OCT and by commercial OCT
Time frame: in the same 1 day
OCT images will be captured by META-OCT and by a commercial OCT, and segmented and analyzed with default algorithm to yield quantitative measurements.
8 secondary outcomes
Level of agreement in axial length measurement
Time frame: in the same 1 day
Level of agreement in spherical equivalent diopter (SED) and astigmatism vector components (J0 and J45)
Time frame: in the same 1 day
Level of agreement in near and far visual acuity measurements
Time frame: in the same 1 day
Level of agreement in detecting ocular abnormalities.
Time frame: in the same 1 day
Repeatability in quantitative measurements provided by META-OCT
Time frame: in the same 1 day
Exam success rate
Time frame: in the same 1 day
Time spent on the examinations
Time frame: in the same 1 day
Patient experience
Time frame: in the same 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Yizhi Liu, M.D., Ph.D. study chair
State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Diseases, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zitian Liu, Ph.D. (+8618319249014, liuzt25@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image Quality (time frame: in the same 1 day). The study lists 2 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 4 Oct 2022.