Multimodal Equipment for Teleophthalmology Assessment (META)

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Eye Diseases
• Intervention / Treatment: Device: META; Device: Commercial devices

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 Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Zitian Liu, Ph.D.; Phone Number: +8618319249014; Email: liuzt25@mail.sysu.edu.cn
• Study Contact Backup: Name: Yingfeng Zheng, M.D., Ph.D.; Phone Number: +8613922286455; Email: zhyfeng@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants with healthy eyes or with common eye diseases.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Device: META; The META device is used for a comprehensive ophthalmic examination.; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Exam success rate	The exam success rate will be obtained by META versus by commercial devices.	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.	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.	in the same 1 day

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Investigators: Study Chair: Yizhi Liu, M.D., Ph.D., State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 15, 2022
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): May 31, 2023

Study Registration Dates

• First Submitted: September 30, 2022
• First Submitted That Met QC Criteria: October 3, 2022
• First Posted (Actual): October 4, 2022

Study Record Updates

• Last Update Posted (Actual): October 4, 2022
• Last Update Submitted That Met QC Criteria: October 3, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases
• Other Study ID Numbers: IIT2022123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No