LFR-260 vs Traditional Phoropter in Visual Acuity Testing

Astigmatism Clinical Trial

Official title:

An Evaluation of the LFR-260 Against a Traditional Phoropter in Visual Acuity Testing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05259163
• Other study ID #: LFR-260-2021
• Status: Completed
• Phase: N/A
• Start date: June 7, 2022
• Est. completion date: January 6, 2023

Study information

• Verified date: April 2023
• Source: Evolution Optiks Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: January 6, 2023
• Est. primary completion date: January 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

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).

6. The participant has diabetic retinopathy.

7. The participant has glaucoma or ocular hypertension.

8. The participant has macular degeneration.

9. The participant has had a previous ocular surgery.

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

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

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

13. 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.

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

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

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

Related Conditions & MeSH terms

• Anisometropia
• Astigmatism
• Visual Acuity

Intervention

Device:
• LFR-260 portable phoropter
Portable unit to evaluate visual refractive state of the patient
• Traditional phoropter (Standard of Care)
Standard unit for evaluating visual refractive state of the patient

Locations

Country	Name	City	State
United States	Gold Coast Optometric Vision	Oyster Bay	New York
United States	MCPHS	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Evolution Optiks Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of LFR260 on Visual Acuity test	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.	Day 0
Primary	Precision of LFR260 in repeated testing	Precision testing will also be conducted to confirm repeatability and reproducibility of the LFR-260.	Day 0
Secondary	Patient Satisfaction Survey	4-question survey (1=worst; 5=best) given to patients to determine satisfaction with LFR-260 device Quad view	Day 0
Secondary	Provider Satisfaction Survey	4-question survey (1=worst; 5=best) given to eye care provider to determine satisfaction with LFR-260 related to usability, convenience	Day 0