LFR-260 vs Traditional Phoropter in Visual Acuity Testing

Sponsor
Evolution Optiks Limited (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05259163
Collaborator
(none)
108
2
2
9
54
6

Study Details

Study Description

Brief Summary

The purpose of this study is to establish if LFR-260 (investigational device) is not inferior in effectiveness to a traditional phoropter (control device) when applied in visual acuity test in subjects undergoing a full routine eye examination. LFR-260 proposes to provide information of the visual capabilities of the patient. The test will be provided and supervised by a qualified eye care provider. The informed consent, screening, randomization (into the order of visual test device used), (visual) device testing (to include precision testing, remote and offsite testing) will all occur at a single visit.

Condition or Disease Intervention/Treatment Phase
  • Device: LFR-260 portable phoropter
  • Device: Traditional phoropter (Standard of Care)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
An Evaluation of the LFR-260 Against a Traditional Phoropter in Visual Acuity Testing
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: LFR-260

The LFR-260 is a portable digital refractor which allows for determination of refractive error as well as for fully remote refractions during eye exams.

Device: LFR-260 portable phoropter
Portable unit to evaluate visual refractive state of the patient

Active Comparator: Traditional phoropter

The traditional phoropter is intended to be used for distance vision testing in any environment. The traditional phoropter is an application-controlled instrument providing the same subjective refraction capabilities for distance vision testing as the standard of care eye examination including sphere, cylinder, and axis.

Device: Traditional phoropter (Standard of Care)
Standard unit for evaluating visual refractive state of the patient

Outcome Measures

Primary Outcome Measures

  1. Effectiveness [Day 0]

    Agreement of LFR-260 (investigational device) to traditional phoropter (comparator device) when applied in visual acuity test in subjects undergoing a full routine eye examination.

  2. Precision [Day 0]

    Precision testing will also be conducted to confirm repeatability and reproducibility of the LFR-260.

Secondary Outcome Measures

  1. Patient Satisfaction [Day 0]

    4-question survey (1=worst; 5=best) given to patients to determine satisfaction with LFR-260 device Quad view

  2. Provider Satisfaction [Day 0]

    4-question survey (1=worst; 5=best) given to eye care provider to determine satisfaction with LFR-260 related to usability, convenience

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. The participant or legal guardian is willing and able to understand, sign and date the Ethics committee approved study specific Informed Consent Form.

  2. The participant is a male or female between the ages of 12 and 65 (inclusive).

  3. The participant has no more than mild to moderate far-sightedness, near-sightedness, astigmatism or anisometropia.

  4. The participant is free of ocular and systemic abnormalities that might affect visual functions.

Exclusion Criteria:
  1. The participant has diabetes mellitus (Type 1 or 2).

  2. The participant has an autoimmune condition.

  3. The participant is pregnant (self-reported).

  4. The participant has an active corneal or conjunctival infection.

  5. The participant has an active corneal, conjunctival, or intraocular inflammation (i.e.

  • uveitis).
  1. The participant has diabetic retinopathy.

  2. The participant has glaucoma or ocular hypertension.

  3. The participant has macular degeneration.

  4. The participant has had a previous ocular surgery.

  5. The participant has ocular and systemic diseases or abnormalities that might affect visual functions.

  6. The participant has a history of amblyopia, strabismus, or any other binocular vision abnormality.

  7. The participant has a history of AMD (age macular degeneration).

  8. The participant is a prisoner, a transient or has been treated for alcohol and/or drug abuse in an inpatient substance abuse program within 6 months prior to proposed study enrolment.

  9. The participant will not be able to complete questionnaires.

  10. The participant is currently in an investigational study for a similar purpose.

  11. The participant, in the judgment of the Investigator, may be inappropriate for the intended study procedures.

Contacts and Locations

Locations

Site City State Country Postal Code
1 MCPHS Worcester Massachusetts United States 01608
2 Gold Coast Optometric Vision Oyster Bay New York United States 11771

Sponsors and Collaborators

  • Evolution Optiks Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Evolution Optiks Limited
ClinicalTrials.gov Identifier:
NCT05259163
Other Study ID Numbers:
  • LFR-260-2021
First Posted:
Feb 28, 2022
Last Update Posted:
Feb 28, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Evolution Optiks Limited
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 28, 2022