Multimodal Equipment for Teleophthalmology Assessment (META)

Not yet recruiting

• Conditions: Eye Diseases
• Interventions: Device: META; Device: Commercial devices

• Registration Number: NCT05565547
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Brief 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).

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 Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-30
• Study First Submitted QC: 2022-10-03
• Last Update Submitted: 2022-10-03
• Study First Posted: 2022-10-04
• Last Update Posted: 2022-10-04
• Study Start: 2022-10-15
• Primary Completion: 2023-03-31
• Study Completion: 2023-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

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).

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with common eye diseases	Commercial devices	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).
Patients with common eye diseases	META	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).

Primary Outcome Measures

Name	Time	Method
Image Quality	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	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.

Secondary Outcome Measures

Name	Time	Method
Level of agreement in axial length measurement	in the same 1 day	Accuracy of axial length measurement will be captured by META-AL versus by a commercial biometric device.
Level of agreement in near and far visual acuity measurements	in the same 1 day	Accuracy of near and far visual acuity measurements will be obtained by META-VA versus by reference ETDRS charts.
Exam success rate	in the same 1 day	The exam success rate will be obtained by META versus by commercial devices.
Time spent on the examinations	in the same 1 day	The time spent on the examinations will be obtained by META versus by commercial devices.
Level of agreement in detecting ocular abnormalities.	in the same 1 day	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.
Level of agreement in spherical equivalent diopter (SED) and astigmatism vector components (J0 and J45)	in the same 1 day	Accuracy of SED and J0 and J45 will be obtained by META-SE versus by a commercial refractor.
Repeatability in quantitative measurements provided by META-OCT	in the same 1 day	OCT images will be captured by META-OCT twice, and the repeatability of quantitative measurements will be assessed.
Patient experience	in the same 1 day	Investigator-administered questionnaires will be used to investigate participants' preferences and confidence to receive META exams in the future.