IMOvifa Perimeter Reference Database

September 27, 2023 updated by: New View Optometric Center
This study will collect data to establish a reference database for the IMOvifa perimeter.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

376

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Topcon Healthcare Innovation Center
      • La Mesa, California, United States, 91942
        • New View Optometric Center
    • Illinois
      • Chicago, Illinois, United States, 60616
        • Illinois College of Optometry
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • New England College of Optometry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Persons with normal visual function

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal
Subjects with normal visual function
Device: Visual field
test for detecting loss in visual function

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reference limit for mean deviation
Time Frame: Day 1
Visual sensitivity level in decibels
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New View Optometric Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

August 4, 2023

Study Completion (Actual)

September 22, 2023

Study Registration Dates

First Submitted

March 17, 2023

First Submitted That Met QC Criteria

March 17, 2023

First Posted (Actual)

March 30, 2023

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • NVOC-2023-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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