IMOvifa Perimeter Reference Database

Normal Eyes Clinical Trial

Official title:

IMOvifa Perimeter Reference Database

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05792046
• Other study ID #: NVOC-2023-02
• Status: Completed
• Start date: March 1, 2023
• Est. completion date: September 22, 2023

Study information

• Verified date: September 2023
• Source: New View Optometric Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 376
• Est. completion date: September 22, 2023
• Est. primary completion date: August 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Normal Eyes

Intervention

Device:
• Visual field
test for detecting loss in visual function

Locations

Country	Name	City	State
United States	New England College of Optometry	Boston	Massachusetts
United States	Illinois College of Optometry	Chicago	Illinois
United States	Topcon Healthcare Innovation Center	La Jolla	California
United States	New View Optometric Center	La Mesa	California

Sponsors (1)

Lead Sponsor	Collaborator
New View Optometric Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reference limit for mean deviation	Visual sensitivity level in decibels	Day 1