Multimodal Equipment for Teleophthalmology Assessment (META)

NCT05565547 | Unknown

• 1 other identifier: IIT2022123
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Eye Diseases

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Level of agreement in axial length measurement

  in the same 1 day

• Level of agreement in spherical equivalent diopter (SED) and astigmatism vector components (J0 and J45)

  in the same 1 day

• Level of agreement in near and far visual acuity measurements

  in the same 1 day

• Level of agreement in detecting ocular abnormalities.

  in the same 1 day

• Repeatability in quantitative measurements provided by META-OCT

  in the same 1 day

Study Arms (1)

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; Device: Commercial devices

Interventions

META DEVICE

The META device is used for a comprehensive ophthalmic examination.

Patients with common eye diseases

Commercial devices 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.

Patients with common eye diseases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with healthy eyes or with common eye diseases.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

MeSH Terms

Conditions

Eye Diseases

Study Officials

• Yizhi Liu, M.D., Ph.D.

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

  STUDY CHAIR

Central Study Contacts

Zitian Liu, Ph.D.

CONTACT

+8618319249014; liuzt25@mail.sysu.edu.cn

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

CONTACT

+8613922286455; zhyfeng@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 4, 2022
• Study Start: October 15, 2022
• Primary Completion: March 31, 2023
• Study Completion: May 31, 2023
• Last Updated: October 4, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share