Vision DisordersNCT05447845
Rapid Computerized Visual Acuity Test
An observational study of Vision Disorders and Refractive Errors, run by Rambam Health Care Campus at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Vision Disorders, Refractive Errors, Retinal Disease
- What is being tested?
- Computerized visual acuity assessment program
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2019to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- age 18 years old and older
Who cannot join
- visual acuity <0.2 decimal for the patient group
- visual acuity <0.5 decimal for the healthy group
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Department of Ophthalmology at Rambam Health Care Campus
Haifa, 3109601
Khaled W Khalifa, BSc, +972545933587, khalid.kh95@gmail.com
About this study
Official title: 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.
- Conditions
- Vision Disorders, Refractive Errors, Retinal Disease, Cataract, Corneal Disease
- Being tested
- Computerized visual acuity assessment program
- Medical subject headings
- Vision Disorders, Refractive Errors, Retinal Diseases, Cataract, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized visual acuity assessment programDiagnostic test
Each subject underwent visual acuity assessments using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart and the computerized program
| Study group | Role | What they receive |
|---|---|---|
| Healthy | healthy volunteers with no known ocular condition Receives: Diagnostic Test: Computerized visual acuity assessment program | |
| Patients | Subjects with diseases of the eye or the orbit Receives: Diagnostic Test: Computerized visual acuity assessment program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start1 Jan 2019
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vision DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eytan Z Blumenthal, MD, Rambam Health Care Campus
- Investigators
- Eytan Z Blumenthal, MD, Principal investigator, Head of the Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447845
- Sponsor's protocol ID
- 0163-17-RMB
- Status last verified
- Jul 2022
- First submitted
- 11 Jun 2022
- Last updated
- 7 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 30829080Cohen 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.
PubMed 33742567
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Rapid, Reproducible and Accurate Computerized Visual Acuity Test
- ClinicalTrials.gov ID
- NCT05447845
- Acronym / sponsor ID
- 0163-17-RMB
- Conditions
- Vision Disorders, Refractive Errors, Retinal Disease, Cataract, Corneal Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Diagnostic Test: Computerized visual acuity assessment programhealthy volunteers with no known ocular condition |
| Patients | – | Diagnostic Test: Computerized visual acuity assessment programSubjects with diseases of the eye or the orbit |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- age 18 years old and older
Key exclusion criteria (2 listed)
- visual acuity <0.2 decimal for the patient group
- visual acuity <0.5 decimal for the healthy group
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized visual acuity assessment programEach subject underwent visual acuity assessments using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart and the computerized program | Diagnostic test | Healthy, Patients |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Background: PubMed 30829080Mimouni 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.
- Background: PubMed 33742567Cohen 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eytan Z Blumenthal, MD principal investigator
Head of the Department of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vision Disorders and Refractive Errors, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Khaled W Khalifa (972545933587, Khalid.kh95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05447845, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022.