Refractive Error CorrectionNCT06583954
SUBJECTIVE REFRACTION WITH LIGHTFIELD TECHNOLOGY
An observational study of Refractive Error Correction, run by Daniela Nosch at 2 sites in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractive Error Correction
- How many people
- 120 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 15 Feb 2025to 30 Aug 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy adults with refractive error
Who may be able to join
- 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
Who cannot join
- • 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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Institute of Optometry, FHNW
Olten, Canton of Solothurn, 4600
Insititute of Optometry, FHNW University of Applied Sciences and Arts Northwestern Switzerland
Olten, 4600
About this study
Official title: 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).
- Conditions
- Refractive Error Correction
- Keywords
- subjective refraction, phoropter, lightfield technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| healthy adults with refractive error | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
precision of determination of refractive error
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).
Measured: within one week
Secondary outcomes (1)
repeatability of all three methods for subjective refraction
Measured: within one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start15 Feb 2025
- Primary completion30 May 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Refractive Error CorrectionStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniela Nosch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniela Nosch, University of Applied Sciences and Arts Northwestern Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583954
- Sponsor's protocol ID
- 2024-D0081
- Other IDs
- 2024-D0081
- Status last verified
- Sep 2025
- First submitted
- 2 Sep 2024
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Venkataraman AP, Sirak D, Brautaset R, Dominguez-Vicent A. Evaluation of the Performance of Algorithm-Based Methods for Subjective Refraction. J Clin Med. 2020 Sep 29;9(10):3144. doi: 10.3390/jcm9103144.
PubMed 33003297
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROOF OF CONCEPT OF A NEW DEVICE FOR SUBJECTIVE REFRACTION WITH LIGHTFIELD TECHNOLOGY
- ClinicalTrials.gov ID
- NCT06583954
- Acronym / sponsor ID
- 2024-D0081
- Conditions
- Refractive Error Correction
- Keywords
- subjective refraction, phoropter, lightfield technology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Daniela NoschUniversity, hospital or other
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 4 Sep 2024 (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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy adults with refractive error | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy adults with refractive error
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- • Contact lens wear during the days of visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
precision of determination of refractive error
Time frame: within one week
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).
1 secondary outcome
repeatability of all three methods for subjective refraction
Time frame: within one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Background: PubMed 33003297Venkataraman AP, Sirak D, Brautaset R, Dominguez-Vicent A. Evaluation of the Performance of Algorithm-Based Methods for Subjective Refraction. J Clin Med. 2020 Sep 29;9(10):3144. doi: 10.3390/jcm9103144.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractive Error Correction, run by Daniela Nosch at 2 sites in Switzerland.
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 7 inclusion and 3 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: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
precision of determination of refractive error (time frame: within one week). 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 NCT06583954, which also lists 1 linked publication.
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 5 Sep 2025.