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Clinical Trials/NCT06583954
NCT06583954CompletedNot Applicable

PROOF OF CONCEPT OF A NEW DEVICE FOR SUBJECTIVE REFRACTION WITH LIGHTFIELD TECHNOLOGY

Daniela Nosch2 sites in 1 country120 target enrollmentStarted: February 15, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
120
Locations
2
Primary Endpoint
precision of determination of refractive error

Study Overview

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).

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • repeatability of all three methods for subjective refraction(within one week)

Investigators

Sponsor
Daniela Nosch
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Daniela Nosch

Lecturer

University of Applied Sciences and Arts Northwestern Switzerland

Study Sites (2)

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