Evaluating iCare COMPASS as a Visual Field Diagnostic Tool

NCT07765147 | Completed FDA Device

• 1 other identifier: 22747
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

this study seeks to compare the Humphrey Visual Field Analyzer and iCare COMPASS for both clinical accuracy and operational advantages.

Conditions

GLAUCOMA 1, OPEN ANGLE, D (Disorder)

Keywords

GLAUCOMA

Outcome Measures

Primary Outcomes (1)

• Visual Fields will be assessed via the current standard of care Humphrey SITA-Faster when available. The mean deviation, pattern standard deviation, mean deviation cluster, and fixation plot obtained will be compared with the same measures on the iCare

  Testing will be performed with either one or two encounters with the patient or as determined by the patients' clinician.

  within 1-3 months post visit

Study Arms (2)

HUMPHREY SITA FASTER VS ICARE COMPASS

ACTIVE COMPARATOR

SUBJECTS WILL BE RANDOMIZED TO TESTING ON THE HUMPHREY SITA FASTER VISUAL FIELD FIRST, THEN WILL TEST ON THE ICARE COMPASS VISUAL FIELD MACHINE

Diagnostic Test: VISUAL FIELD TESTING

ICARE COMPASS VS HUMPHREY SITA FASTER

ACTIVE COMPARATOR

SUBJECTS WILL BE RANDOMIZED TO TEST FIRST ON THE ICARE COMPASS VISUAL FIELD MACHINE, THEN WILL TEST ON THE HUMPHREY SITA FASTER VISUAL FIELD MACHINE

Diagnostic Test: VISUAL FIELD TESTING

Interventions

VISUAL FIELD TESTING DIAGNOSTIC_TEST

This study will be a crossover study. Patients who express interest in taking part in the study will be evaluated using Humphrey SITA-faster, which is the current standard of care for visual perimetry, and the iCare COMPASS in the same visit. Participants will be assigned to one of two groups of alternating testing order with the Humphrey Visual Field Analyzer vs the iCare COMPASS and vice versa. The mean deviation, pattern standard deviation, mean deviation cluster, and fixation plot results will be compared. For analysis, participants will be grouped according to the inclusion criteria.

HUMPHREY SITA FASTER VS ICARE COMPASS; ICARE COMPASS VS HUMPHREY SITA FASTER

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All consenting patients who arrive for glaucoma management appointments for objective(s) 2.1.1, 2.2.2
• Patient groups arriving for glaucoma management that will be targeted for enrollment include: glaucoma suspect patients, those with cataracts, optic atrophy, macular degeneration, macular pathology, and vascular diseases of the retina

You may not qualify if:

• Those who are unwilling or unable to provide consent
• Those for which English is not their first language

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Eugene and Marilyn Glick Eye Institute

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Visual Fields

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Ocular Physiological Phenomena

Study Officials

• MASOOD MOHAMMADI, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Ophthalmology

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 14, 2026
• Study Start: February 7, 2025
• Primary Completion: January 16, 2026
• Study Completion: January 16, 2026
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)