IMOvifa Perimeter Reference Database

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

376 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2023-09-22

Brief Summary

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

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Detailed Description

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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.

Conditions

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Normal Eyes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal

Subjects with normal visual function

Visual field

Intervention Type DEVICE

test for detecting loss in visual function

Interventions

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Visual field

test for detecting loss in visual function

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes