An observational study in Eye Diseases, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-04.
Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Observational
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).
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.
740 studies on the registry are indexed under Eye Diseases; 117 are open to participants now.
This study's planned enrollment of 400 is above the median of 120 across 172 observational studies indexed under Eye Diseases.
Browse Eye Diseases studies →Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 159 studies on the registry; 77 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants with healthy eyes or with common eye diseases.
Exclusion Criteria:
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).
Device: META · Device: Commercial devices
The META device is used for a comprehensive ophthalmic examination.
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.
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
Time frame: 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.
Time frame: in the same 1 day
Level of agreement in axial length measurement
Accuracy of axial length measurement will be captured by META-AL versus by a commercial biometric device.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: in the same 1 day
Exam success rate
The exam success rate will be obtained by META versus by commercial devices.
Time frame: 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.
Time frame: 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.
Time frame: in the same 1 day
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Zhongshan Ophthalmic Center, Sun Yat-sen University