Multimodal Equipment for Teleophthalmology Assessment (META)

NCT ID: NCT05565547

Last Updated: 2022-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-15

Study Completion Date

2023-05-31

Brief Summary

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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

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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

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Eye Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

META

Intervention Type DEVICE

The META device is used for a comprehensive ophthalmic examination.

Commercial devices

Intervention Type DEVICE

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.

Interventions

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META

The META device is used for a comprehensive ophthalmic examination.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yizhi Liu, M.D., Ph.D.

Role: STUDY_CHAIR

State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University

Central Contacts

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Zitian Liu, Ph.D.

Role: CONTACT

+8618319249014

Yingfeng Zheng, M.D., Ph.D.

Role: CONTACT

+8613922286455

Other Identifiers

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IIT2022123

Identifier Type: -

Identifier Source: org_study_id

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