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Completed

NCT Number: NCT05792046

IMOvifa Perimeter Reference Database

This study will collect data to establish a reference database for the IMOvifa perimeter.

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Key information

Conditions

Normal Eyes

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Topcon Healthcare Innovation Center, La Jolla, California, United States

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About this study

This study will collect data from a reference population to be used as inputs to the calculation of age corrected significance limits for expected visual function sensitivity to establish reference limits for key output parameters for select test patterns of the IMOvifa perimeter device.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 22 years of age or older on the date of informed consent
  • Able to understand the written informed consent and willing to participate
  • IOP ≤ 21 mmHg (each eye)
  • BCVA 20/40 or better (each eye)
  • Both eyes free of ocular conditions that may affect visual function (at doctor's discretion)

Exclusion criteria

  • Unable to tolerate ophthalmic imaging and/or VF testing
  • History of conditions known to adversely affect visual function (at doctor discretion)
  • Spherical Equivalent refractive error outside the range from +6 Diopters
  • Cylindrical refractive error outside the range +2.5 Diopters

Treatment and study plan

Visual field

Device

test for detecting loss in visual function

Primary outcomes

  1. Reference limit for mean deviation

    Time frame: Day 1

    Visual sensitivity level in decibels

Sponsors and collaborators

Lead sponsor

New View Optometric Center

Industry

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 30, 2023
Registry last updated
Sep 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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