Comparison of Visual Field Assessments Between Three Perimeters

Gainesville Eye Associates

Status and phase: Completed; Phase 4

Conditions: Glaucoma

Treatments: Diagnostic Test: Visual field assessment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06539715

CB-24-01 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 3 patient groups

TEMPO

Experimental group

Description:

Visual field assessment with the TEMPO

Treatment:

Diagnostic Test: Visual field assessment

Humphrey Field Analyzer

Active Comparator group

Description:

Visual field assessment with the Humphrey Field Analyzer

Treatment:

Diagnostic Test: Visual field assessment

VisuALL

Active Comparator group

Description:

Visual field assessment with the VisuALL

Treatment:

Diagnostic Test: Visual field assessment