Evaluating Home Testing Devices for the Management of Glaucoma

NCT05325996 | Completed FDA Device

• 1 other identifier: IRB# 2021-79
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

With the advancement in technology we have the opportunity of performing the glaucoma testing at home to monitor the disease. The purpose of this study is evaluating the feasibility and patient acceptance of home testing with head mounted perimetry; detection of progression with head mounted perimetry vs office based perimetry; and monitoring the eye pressure measured by patients at home using a portable tonometer.

Conditions

Glaucoma, Open-Angle

Keywords

Open Angle Glaucoma; Perimetery; Tonometry; Eye Pressure; Visual Field; Home Test

Outcome Measures

Primary Outcomes (2)

• Change in Visual Field Mean Deviation with VisuALL

  The visual field measures sensitivity of the retina to light at several locations in the peripheral vision. The difference of mean of these measurements compared to a normal database is presented in negative or positive values called mean deviation. Visual field mean deviation (MD) (light measurement in decibels in multiple spots across the central and peripheral retina known as entire visual field) will be captured by VisuALL per eye once a week during a 2 year period at participant's home.

  12 minutes each week for 104 weeks

• Change in Intraocular Pressure with iCare

  Intraocular pressure, measured in millimeters of mercury (mmHG), will be measured by patients using a device called iCare Home Tonometer, specifically designed for patients to measure their eye pressures at home. They will measure eye pressure of each eye 3 times a day for 7 days every 3 months during a 2 year period at participant's home.

  15 minutes daily over 1 week, 8 times for 2 years

Secondary Outcomes (1)

• Change in Visual Field Mean Deviation with Humphrey Field Analyzer

  2 hours, 5 times for 2 years

Other Outcomes (1)

• Change in Retinal Nerve Fiber Layer (RNFL) Thickness

  10 minutes, 3 times for 2 years

Study Arms (1)

Moderate Glaucoma

EXPERIMENTAL

Subjects between ages 20-80 years with a diagnosis of mild and moderate Open Angle Glaucoma in at least one eye with 20/50 vision or better will be included in this study. All subjects will have the Olleyes Perimeter measure their own visual acuity and field once a week during a 2 year period and iCare home to measure their eye pressure 3 times a day for 7 days every 3 months during a 2 year period. All patient will have their routine glaucoma assessment with the standard 24-2 Automatic Perimetry Humphrey Field Analyzer at baseline and every 6 months during a 2 year period; and Spectralis Optical Coherence Tomography thickness of peripapillary RNFL and macular ganglion cell at baseline and yearly during a 2 year period.

Diagnostic Test: Standard Automatic Perimetry Humphrey Field Analyzer; Diagnostic Test: visuALL H; Diagnostic Test: iCare Home Tonometer; Diagnostic Test: Spectralis Optical coherence tomography (OCT)

Interventions

Standard Automatic Perimetry Humphrey Field Analyzer DIAGNOSTIC_TEST

Standard Automatic Perimetry (SAP) using the Swedish Interactive Threshold Algorithm (SITA) Standard Strategy measures the visual field in an ophthalmic setting.

Also known as: SAP HFA

Moderate Glaucoma

visuALL H DIAGNOSTIC_TEST

visuALL H a new portable perimeter measuring the visual field and acuity in a non ophthalmic setting.

Moderate Glaucoma

iCare Home Tonometer DIAGNOSTIC_TEST

iCare HOME tonometer is a device developed for patients/subjects to measure their eye pressure at home.

Moderate Glaucoma

Spectralis Optical coherence tomography (OCT) DIAGNOSTIC_TEST

Optical coherence tomography (OCT) is a computerized picture measuring the thickness of the inner layer of the retina that makes the optic nerve.

Moderate Glaucoma

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20-80 years
• Mild and Moderate Open Angle Glaucoma (OAG)
• Refraction under 12.00 diopter of spherical refractive error and astigmatism of less than 2.5 diopter.

You may not qualify if:

• Spherical refraction outside \> ± 12.00 D and cylinder correction \> +2.5 D.
• Visual acuity worse than 20/50 either eye
• Cataract surgery with or without Minimally Invasive Glaucoma Surgery (MIGS) less than 90 days prior to enrollment
• Filtering surgeries less than 6 months prior to enrollment
• Intraocular surgery other than:
• Non-complicated MIGS more than 90 days prior to enrollment;
• Cataract or refractive surgery performed more than 90 days before enrollment and without posterior capsule opacification
• Other glaucoma surgery more than 6 months prior to enrollment.
• History of systemic or ocular condition (other than glaucoma or mild to moderate cataract) known to affect visual function.
• History of medication known to affect visual function or influence patient reaction time
• Inability to use device after remote training session
• Subjects unwilling and/or unable to participate

Sponsors & Collaborators

• Wills Eye: lead

Study Sites (1)

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• M. Reza Razeghinejad, MD

  Wills Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 13, 2022
• Study Start: April 15, 2022
• Primary Completion: February 17, 2025
• Study Completion: February 17, 2025
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)