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OpenTrials
Completed

NCT Number: NCT06539715

Comparison of Visual Field Assessments Between Three Perimeters

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

North Georgia Eye Associates

Gainesville, Georgia, 30501, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Visual field assessment

Diagnostic Test

Automated perimetry

Primary outcomes

  1. Total Acquisition Time (Both Eyes)

    Time frame: Visit 1 (Day 0)

    The total time to complete automated perimetry in both eyes.

Secondary outcomes

  1. Mean Deviation (MD)

    Time frame: Visit 1 (Day 0)

    visual field mean deviation (unit = decibels)

  2. 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.

  3. Foveal Threshold (FT)

    Time frame: Visit 1 (Day 0)

    visual field foveal threshold (unit = decibels)

  4. 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.

Other outcomes

  1. Visual Field Index (VFI)

    Time frame: Visit 1 (Day 0)

    Visual field Index goes from 100% = perfect to 0% = no vision

  2. 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.

Sponsors and collaborators

Lead sponsor

Gainesville Eye Associates

Other

Collaborators

  • Sengi

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 6, 2024
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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