Clinical trial NCT05565547: Multimodal Equipment for Teleophthalmology Assessment (META)
Official title: Clinical Validation Study for Multimodal Equipment for Teleophthalmology Assessment (META) Device
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Eye Diseases
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with healthy eyes or with common eye diseases.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Image Quality
timeFrame: in the same 1 day
measure: Level of agreement in quantitative measurements provided by META-OCT and by commercial OCT
timeFrame: in the same 1 day
Secondary outcomes:
measure: Level of agreement in axial length measurement
timeFrame: in the same 1 day
measure: Level of agreement in spherical equivalent diopter (SED) and astigmatism vector components (J0 and J45)
timeFrame: in the same 1 day
measure: Level of agreement in near and far visual acuity measurements
timeFrame: in the same 1 day
measure: Level of agreement in detecting ocular abnormalities.
timeFrame: in the same 1 day
measure: Repeatability in quantitative measurements provided by META-OCT
timeFrame: in the same 1 day
measure: Exam success rate
timeFrame: in the same 1 day
measure: Time spent on the examinations
timeFrame: in the same 1 day
measure: Patient experience
timeFrame: in the same 1 day
Other outcomes:
Locations:
Study officials:
affiliation: State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Yizhi Liu, M.D., Ph.D.
role: STUDY_CHAIR
References: