Multimodal Equipment for Teleophthalmology Assessment (META)

Eye Diseases Clinical Trial

Official title:

Clinical Validation Study for Multimodal Equipment for Teleophthalmology Assessment (META) Device

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05565547
• Other study ID #: IIT2022123
• Status: Not yet recruiting
• Start date: October 15, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: September 2022
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: Zitian Liu, Ph.D.
• Phone: +8618319249014
• Email: liuzt25[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: May 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• Ocular trauma or postoperative eyes within 3 months.
• Study eye(s) with dilated pupil.

Related Conditions & MeSH terms

• Eye Diseases

Intervention

Device:
• META
The META device is used for a comprehensive ophthalmic examination.
• Commercial devices
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	in the same 1 day
Primary	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.	in the same 1 day
Secondary	Level of agreement in axial length measurement	Accuracy of axial length measurement will be captured by META-AL versus by a commercial biometric device.	in the same 1 day
Secondary	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.	in the same 1 day
Secondary	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.	in the same 1 day
Secondary	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.	in the same 1 day
Secondary	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.	in the same 1 day
Secondary	Exam success rate	The exam success rate will be obtained by META versus by commercial devices.	in the same 1 day
Secondary	Time spent on the examinations	The time spent on the examinations will be obtained by META versus by commercial devices.	in the same 1 day
Secondary	Patient experience	Investigator-administered questionnaires will be used to investigate participants' preferences and confidence to receive META exams in the future.	in the same 1 day