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Status:

COMPLETED

LFR-260 vs Traditional Phoropter in Visual Acuity Testing

Lead Sponsor:

Evolution Optiks Limited

Conditions:

Visual Acuity

Astigmatism

Eligibility:

All Genders

12-65 years

Phase:

NA

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 subject...

Eligibility Criteria

Inclusion

  • The participant or legal guardian is willing and able to understand, sign and date the Ethics committee approved study specific Informed Consent Form.
  • The participant is a male or female between the ages of 12 and 65 (inclusive).
  • The participant has no more than mild to moderate far-sightedness, near-sightedness, astigmatism or anisometropia.
  • The participant is free of ocular and systemic abnormalities that might affect visual functions.

Exclusion

  • The participant has diabetes mellitus (Type 1 or 2).
  • The participant has an autoimmune condition.
  • The participant is pregnant (self-reported).
  • The participant has an active corneal or conjunctival infection.
  • The participant has an active corneal, conjunctival, or intraocular inflammation (i.e. - uveitis).
  • The participant has diabetic retinopathy.
  • The participant has glaucoma or ocular hypertension.
  • The participant has macular degeneration.
  • The participant has had a previous ocular surgery.
  • The participant has ocular and systemic diseases or abnormalities that might affect visual functions.
  • The participant has a history of amblyopia, strabismus, or any other binocular vision abnormality.
  • The participant has a history of AMD (age macular degeneration).
  • 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.
  • The participant will not be able to complete questionnaires.
  • The participant is currently in an investigational study for a similar purpose.
  • The participant, in the judgment of the Investigator, may be inappropriate for the intended study procedures.

Key Trial Info

Start Date :

June 7 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 6 2023

Estimated Enrollment :

112 Patients enrolled

Trial Details

Trial ID

NCT05259163

Start Date

June 7 2022

End Date

January 6 2023

Last Update

September 25 2024

Active Locations (2)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (2 locations)

1

MCPHS

Worcester, Massachusetts, United States, 01608

2

Gold Coast Optometric Vision

Oyster Bay, New York, United States, 11771