Comparison of Visual Field Assessments Between Three Perimeters

NCT ID: NCT06539715

Last Updated: 2025-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-18

Study Completion Date

2025-03-12

Brief Summary

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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.

Detailed Description

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Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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TEMPO

Visual field assessment with the TEMPO

Group Type EXPERIMENTAL

Visual field assessment

Intervention Type DIAGNOSTIC_TEST

Automated perimetry

Humphrey Field Analyzer

Visual field assessment with the Humphrey Field Analyzer

Group Type ACTIVE_COMPARATOR

Visual field assessment

Intervention Type DIAGNOSTIC_TEST

Automated perimetry

VisuALL

Visual field assessment with the VisuALL

Group Type ACTIVE_COMPARATOR

Visual field assessment

Intervention Type DIAGNOSTIC_TEST

Automated perimetry

Interventions

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Visual field assessment

Automated perimetry

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sengi

INDUSTRY

Sponsor Role collaborator

Gainesville Eye Associates

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clayton Blehm, MD

Role: PRINCIPAL_INVESTIGATOR

North Georgia Eye Associates

Locations

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North Georgia Eye Associates

Gainesville, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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CB-24-01

Identifier Type: -

Identifier Source: org_study_id

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