NCT05792046

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
376

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2023

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

March 17, 2023

Last Update Submit

September 27, 2023

Conditions

Normal Eyes

Outcome Measures

Primary Outcomes (1)

  • Reference limit for mean deviation

    Visual sensitivity level in decibels

    Day 1

Study Arms (1)

Normal

Subjects with normal visual function

Device: Visual field

Interventions

Visual fieldDEVICE

test for detecting loss in visual function

Normal

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Persons with normal visual function

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Topcon Healthcare Innovation Center

La Jolla, California, 92037, United States

Location

New View Optometric Center

La Mesa, California, 91942, United States

Location

Illinois College of Optometry

Chicago, Illinois, 60616, United States

Location

New England College of Optometry

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

Visual Field Tests

Intervention Hierarchy (Ancestors)

Vision TestsDiagnostic Techniques, OphthalmologicalDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2023

First Posted

March 30, 2023

Study Start

March 1, 2023

Primary Completion

August 4, 2023

Study Completion

September 22, 2023

Last Updated

September 29, 2023

Record last verified: 2023-09

Locations

US(4)