Comparison of Visual Field Assessments Between Three Perimeters

April 9, 2026 updated by: Gainesville Eye Associates
A single center, prospective, randomized, comparative study of visual field assessments between the TEMPO, VisuALL, and HFA perimeters. Subjects will be assessed at 1 visit. Clinical evaluations will include MD, PSD, FT, VFI, OCT, and a questionnaire.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 4

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
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • North Georgia Eye Associates

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients with best-corrected visual outcomes of 20/30 or better.

Exclusion Criteria:

  • Unable to tolerate ophthalmic imaging
  • Any ocular or systemic conditions, that could affect VF test results, such as age-related macular degeneration, peripheral retinal disease, or severe glaucoma.

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TEMPO
Visual field assessment with the TEMPO
Diagnostic test: Visual field assessment
Automated perimetry
Active Comparator: Humphrey Field Analyzer
Visual field assessment with the Humphrey Field Analyzer
Diagnostic test: Visual field assessment
Automated perimetry
Active Comparator: VisuALL
Visual field assessment with the VisuALL
Diagnostic test: Visual field assessment
Automated perimetry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Acquisition Time (Both Eyes)
Time Frame: Visit 1 (Day 0)
The total time to complete automated perimetry in both eyes.
Visit 1 (Day 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Deviation (MD)
Time Frame: Visit 1 (Day 0)
visual field mean deviation (unit = decibels)
Visit 1 (Day 0)
Pattern Standard Deviation (PSD)
Time Frame: Visit 1 (Day 0)
visual field pattern standard deviation (unit = decibels) PSD is a measure of visual field irregularity.
Visit 1 (Day 0)
Foveal Threshold (FT)
Time Frame: Visit 1 (Day 0)
visual field foveal threshold (unit = decibels)
Visit 1 (Day 0)
Patient Questionnaire
Time Frame: Visit 1 (Day 0)
A series of 9 Likert style questions (Strongly Disagree to Strongly Agree) that patients answered about the comfort, ease of use, and anxiety with each device. Strongly Agree was considered a better outcome for comfort and ease of use questions, and Strongly Disagree was considered a better outcome for anxiety questions.
Visit 1 (Day 0)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Field Index (VFI)
Time Frame: Visit 1 (Day 0)
Visual field Index goes from 100% = perfect to 0% = no vision
Visit 1 (Day 0)
Setup Time
Time Frame: Visit 1 (Day 0)
Total setup time was defined as the time from first instructions to each participant up to visual field acquisition start.
Visit 1 (Day 0)

Collaborators and Investigators

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

Sponsor

Gainesville Eye Associates

Collaborators

Sengi

Investigators

  • Principal Investigator: Clayton Blehm, MD, North Georgia Eye Associates

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)

November 18, 2024

Primary Completion (Actual)

March 12, 2025

Study Completion (Actual)

March 12, 2025

Study Registration Dates

First Submitted

July 25, 2024

First Submitted That Met QC Criteria

August 1, 2024

First Posted (Actual)

August 6, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CB-24-01 (prior cCAM Biotherapeutics Ltd Protocol Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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