Rapid Computerized Visual Acuity Test

July 3, 2022 updated by: Eytan Z Blumenthal, MD, Rambam Health Care Campus

A Novel Rapid, Reproducible and Accurate Computerized Visual Acuity Test

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Department of Ophthalmology at Rambam Health Care Campus
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 118 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • healthy volunteers with no known ocular condition or past ocular surgery for the healthy group.
  • patients with ocular conditions who presented for treatment at the Department of Ophthalmology at the Outpatient Clinic at Rambam Health Care Campus

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy
healthy volunteers with no known ocular condition
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
Patients
Subjects with diseases of the eye or the orbit
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity
Time Frame: through study completion, an average of 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Investigators

  • Principal Investigator: Eytan Z Blumenthal, MD, Head of the Department of Ophthalmology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

October 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

June 11, 2022

First Submitted That Met QC Criteria

July 3, 2022

First Posted (Actual)

July 7, 2022

Study Record Updates

Last Update Posted (Actual)

July 7, 2022

Last Update Submitted That Met QC Criteria

July 3, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0163-17-RMB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The data collected is relevant to the computerized software developed by the team, the software is currently not available for other researchers' use. Therefore, sharing IPD will not be of further investigational importance to researchers out of the study team.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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