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NCT05447845 Clinical Trial

Rapid Computerized Visual Acuity Test

Cataract Clinical Trial

Official title:
A Novel Rapid, Reproducible and Accurate Computerized Visual Acuity Test

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05447845
Other study ID # 0163-17-RMB
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date December 31, 2022

Study information
Verified date July 2022
Source Rambam Health Care Campus
Contact Khaled W Khalifa
Phone 972545933587
Email Khalid.kh95@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A novel computerized visual acuity test was developed and tested on both healthy persons and patients with ocular conditions. Visual acuity outcomes of the computerized test will be compared to the Early Treatment Diabetic Retinopathy Study (ETDRS) in measures of reproducibility, accuracy and numbers of questions.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 31, 2022
Est. primary completion date October 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 120 Years
Eligibility Inclusion Criteria: - age 18 years old and older Exclusion Criteria: - visual acuity <0.2 decimal for the patient group - visual acuity <0.5 decimal for the healthy group

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Computerized visual acuity assessment program
Each subject underwent visual acuity assessments using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart and the computerized program

Locations
Country Name City State
Israel Department of Ophthalmology at Rambam Health Care Campus Haifa

Sponsors (1)
Lead Sponsor Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

References & Publications (2)

Cohen ADN, Mimouni M, El-Yaniv R, Blumenthal EZ. Shortening the Early Treatment Diabetic Retinopathy Study visual acuity test utilizing a novel computer software: reproducibility in control and patient eyes. Acta Ophthalmol. 2021 Dec;99(8):e1281-e1288. doi: 10.1111/aos.14807. Epub 2021 Mar 19. — View Citation

Mimouni M, Shamir RR, Cohen AD, El-Yaniv R, Cohen MJ, Joskowicz L, Blumenthal EZ. A Comparison of different scoring terminations rules for visual acuity testing: from a computer simulation to a clinical study. Curr Eye Res. 2019 Jul;44(7):790-795. doi: 10.1080/02713683.2019.1589524. Epub 2019 Apr 8. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Visual acuity visual acuity was displayed in decimal units in the computerized program and by the number of letters in the early treatment diabetic retinopathy study chart (ETDRS). through study completion, an average of 1 year
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