NCT05447845

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

July 7, 2022

Status Verified

July 1, 2022

Enrollment Period

3.8 years

First QC Date

June 11, 2022

Last Update Submit

July 3, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Healthy

healthy volunteers with no known ocular condition

Diagnostic Test: Computerized visual acuity assessment program

Patients

Subjects with diseases of the eye or the orbit

Diagnostic Test: Computerized visual acuity assessment program

Interventions

Each subject underwent visual acuity assessments using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart and the computerized program

HealthyPatients

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • \- age 18 years old and older

You may not qualify if:

  • visual acuity \<0.2 decimal for the patient group
  • visual acuity \<0.5 decimal for the healthy group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology at Rambam Health Care Campus

Haifa, 3109601, Israel

RECRUITING

Related Publications (2)

  • 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.

    PMID: 30829080BACKGROUND
  • 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.

    PMID: 33742567BACKGROUND

MeSH Terms

Conditions

Vision DisordersRefractive ErrorsRetinal DiseasesCataractCorneal Diseases

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsLens Diseases

Study Officials

  • Eytan Z Blumenthal, MD

    Head of the Department of Ophthalmology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Khaled W Khalifa

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Department of Ophthalmology

Study Record Dates

First Submitted

June 11, 2022

First Posted

July 7, 2022

Study Start

January 1, 2019

Primary Completion

October 31, 2022

Study Completion

December 31, 2022

Last Updated

July 7, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

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.

Locations