NCT05325996

Evaluating Home Testing Devices for the Management of Glaucoma

Evaluating Effectiveness of Home Testing Devises for Assisting in Management of Glaucoma Outside a Clinical Setting During a 2 Year Period.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Wills Eye · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Standard Automatic Perimetry (SAP) is the gold standard test for evaluation of diseases of the visual pathway like glaucoma. Its main goal is to measure differential light sensitivity at several locations in the field of vision. Several devices have been developed since the advent of the Octopus Perimeter and the Humphrey Field Analyzer (HFA) is now the most commonly used machine for checking the visual field. These devices have a number of disadvantages including being stressful for debilitated, ill, or elderly patients to keep their heads still in the perimeter bowl during the test. Recently, several methods have been introduced for checking the visual field using laptops or iPads. These modalities bring portability but lack fixation methods, environmental control, hardware standardization, and lack the ability of checking the visual acuity. These deficiencies may limit their wide usage. VisuALL is a Head Mounted perimeter that connects to its application on the cell phone or tablet via Bluetooth. In addition to being a portable perimeter and checking visual acuity, it has the ability of monitoring fixation with an accuracy of 1 degree. The measured visual field will be saved on a cloud space and available to the physician and patient. It has been shown that the more frequent visual tests we perform, the earlier we would be able to detect visual field progression. Currently, the visual field test is performed on patients in an ophthalmology clinic with a technician present during the test. The VisuALL has a demo video to provide education to the patient on the simple and user-friendly process of visual field testing. Tonometry is the measurement of eye pressure. iCare Home Tonometer measurements have been shown to be highly correlated to Goldmann Tonometer measurements which are performed in the ophthalmic office. Multiple studies have highlighted the shortcomings of relatively infrequent in office tonometry. Recent studies have suggested that peak out of office eye pressures are often higher than in office pressures and the iCare Home Tonometer is one option to assess eye pressure outside of the office. Home monitoring of glaucoma may present opportunities to reduce the burdens of office visits while increasing the monitoring of the visual field and eye pressure. This study is intended to assess the feasibility and utility of home based perimetry and tonometry in the management of glaucoma.

Conditions

• Glaucoma, Open-Angle

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Standard Automatic Perimetry Humphrey Field Analyzer	Standard Automatic Perimetry (SAP) using the Swedish Interactive Threshold Algorithm (SITA) Standard Strategy measures the visual field in an ophthalmic setting.
DIAGNOSTIC_TEST	visuALL H	visuALL H a new portable perimeter measuring the visual field and acuity in a non ophthalmic setting.
DIAGNOSTIC_TEST	iCare Home Tonometer	iCare HOME tonometer is a device developed for patients/subjects to measure their eye pressure at home.
DIAGNOSTIC_TEST	Spectralis Optical coherence tomography (OCT)	Optical coherence tomography (OCT) is a computerized picture measuring the thickness of the inner layer of the retina that makes the optic nerve.

Timeline

• Start date: 2022-04-15
• Primary completion: 2025-02-17
• Completion: 2025-02-17
• First posted: 2022-04-13
• Last updated: 2025-11-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study