Multimodal Equipment for Teleophthalmology Assessment (META)

Sun Yat-sen University

Status: Not yet enrolling

Conditions: Eye Diseases

Treatments: Device: Commercial devices; Device: META

Study type: Observational

Funder types: Other

Identifiers

NCT05565547

IIT2022123

Details and patient eligibility

About

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).

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

400 participants in 1 patient group

Patients with common eye diseases

Description:

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).

Treatment:

Device: META

Device: Commercial devices