- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06583954
SUBJECTIVE REFRACTION WITH LIGHTFIELD TECHNOLOGY
September 4, 2025 updated by: Daniela Nosch
PROOF OF CONCEPT OF A NEW DEVICE FOR SUBJECTIVE REFRACTION WITH LIGHTFIELD TECHNOLOGY
The aim of this study is to test whether it is possible in principle to determine defective vision using light field technology.
The measurements with this first prototype will be compared with the results of the conventional method for subjective refraction determination and those using a phoropter (Vision R-800 phoropter).
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Olten, Switzerland, 4600
- Insititute of Optometry, FHNW University of Applied Sciences and Arts Northwestern Switzerland
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Canton of Solothurn
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Olten, Canton of Solothurn, Switzerland, 4600
- Institute of Optometry, FHNW
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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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
healthy adults with refractive error
Description
Inclusion Criteria:
- Minimum age of 18 years
- Best corrected visual acuity ≥ 0.8 (logMAR ≤ 0.1).
- Dioptric range for hypermetropia: ≤ +4.50 D.
- Dioptric range for myopia: ≥ -6.50 D.
- Dioptric range for cylinder: ≤ -2.00 D.
- Good general health, i.e.no systemic disease such as diabetes or rheumatism which could influence ocular health
- No ocular pathology or history of (intra)ocular surgery except for cataract surgery
Exclusion Criteria:
• Contact lens wear during the days of visit
- Binocular vision problems (e.g. amblyopia, strabismus).
- Inability to follow the procedures of the investigation, such as language problems, psychological disorders and dementia
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
Cohorts and Interventions
Group / Cohort |
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healthy adults with refractive error
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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precision of determination of refractive error
Time Frame: within one week
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To explore if this prototype CREAL device based on LightField Technology can determine the refractive error reliably, in comparison to well-established methods such as subjective refraction with a trial frame and with the phoropter Vision-R 800 (Essilor SA).
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within one week
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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repeatability of all three methods for subjective refraction
Time Frame: within one week
|
within one week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
Helpful Links
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)
February 15, 2025
Primary Completion (Actual)
May 30, 2025
Study Completion (Actual)
August 30, 2025
Study Registration Dates
First Submitted
September 2, 2024
First Submitted That Met QC Criteria
September 2, 2024
First Posted (Actual)
September 4, 2024
Study Record Updates
Last Update Posted (Estimated)
September 5, 2025
Last Update Submitted That Met QC Criteria
September 4, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-D0081 (Registry Identifier: Swissethics)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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