NCT06583954

Brief 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 phoropter).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

September 2, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 4, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

February 15, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

September 5, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

September 2, 2024

Last Update Submit

September 4, 2025

Conditions

Keywords

subjective refractionphoropterlightfield technology

Outcome Measures

Primary Outcomes (1)

  • 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).

    within one week

Secondary Outcomes (1)

  • repeatability of all three methods for subjective refraction

    within one week

Study Arms (1)

healthy adults with refractive error

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

healthy adults with refractive error

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institute of Optometry, FHNW

Olten, Canton of Solothurn, 4600, Switzerland

Location

Insititute of Optometry, FHNW University of Applied Sciences and Arts Northwestern Switzerland

Olten, 4600, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 33003297BACKGROUND

Related Links

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 2, 2024

First Posted

September 4, 2024

Study Start

February 15, 2025

Primary Completion

May 30, 2025

Study Completion

August 30, 2025

Last Updated

September 5, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations