Clinical trial NCT05325996: Evaluating Home Testing Devices for the Management of Glaucoma
Official title: Evaluating Effectiveness of Home Testing Devises for Assisting in Management of Glaucoma Outside a Clinical Setting During a 2 Year Period.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glaucoma, Open-Angle
Keywords: Open Angle Glaucoma
Perimetery
Tonometry
Eye Pressure
Visual Field
Home Test
Lead sponsor: Wills Eye
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Spherical refraction outside \> ± 12.00 D and cylinder correction \> +2.5 D.
2. Visual acuity worse than 20/50 either eye
3. Cataract surgery with or without Minimally Invasive Glaucoma Surgery (MIGS) less than 90 days prior to enrollment
4. Filtering surgeries less than 6 months prior to enrollment
5. Intraocular surgery other than:

   1. Non-complicated MIGS more than 90 days prior to enrollment;
   2. Cataract or refractive surgery performed more than 90 days before enrollment and without posterior capsule opacification
   3. Other glaucoma surgery more than 6 months prior to enrollment.
6. History of systemic or ocular condition (other than glaucoma or mild to moderate cataract) known to affect visual function.
7. History of medication known to affect visual function or influence patient reaction time
8. Inability to use device after remote training session
9. Subjects unwilling and/or unable to participate

Primary outcomes:
measure: Change in Visual Field Mean Deviation with VisuALL
timeFrame: 12 minutes each week for 104 weeks
measure: Change in Intraocular Pressure with iCare
timeFrame: 15 minutes daily over 1 week, 8 times for 2 years
Secondary outcomes:
measure: Change in Visual Field Mean Deviation with Humphrey Field Analyzer
timeFrame: 2 hours, 5 times for 2 years
Other outcomes:
measure: Change in Retinal Nerve Fiber Layer (RNFL) Thickness
timeFrame: 10 minutes, 3 times for 2 years
Locations:
city: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
Study officials:
affiliation: Wills Eye Hospital
name: M. Reza Razeghinejad, MD
role: PRINCIPAL_INVESTIGATOR
References: