Glaucoma, Open-AngleNCT05325996
Evaluating Home Testing Devices for the Management of Glaucoma
A study testing Standard Automatic Perimetry Humphrey Field Analyzer, visuALL H and iCare Home Tonometer in people with Glaucoma, Open-Angle, run by Wills Eye at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Glaucoma, Open-Angle
- What is being tested?
- Standard Automatic Perimetry Humphrey Field Analyzer, visuALL H and iCare Home Tonometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2022to 17 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: Evaluating Effectiveness of Home Testing Devises for Assisting in Management of Glaucoma Outside a Clinical Setting During a 2 Year Period.
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.
Read the 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
- Being tested
- Standard Automatic Perimetry Humphrey Field Analyzer, visuALL H, iCare Home Tonometer, Spectralis Optical coherence tomography (OCT)
- Keywords
- Open Angle Glaucoma, Perimetery, Tonometry, Eye Pressure, Visual Field, Home Test
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Automatic Perimetry Humphrey Field AnalyzerDiagnostic test
Also called SAP HFA
Standard Automatic Perimetry (SAP) using the Swedish Interactive Threshold Algorithm (SITA) Standard Strategy measures the visual field in an ophthalmic setting.
visuALL HDiagnostic test
visuALL H a new portable perimeter measuring the visual field and acuity in a non ophthalmic setting.
iCare Home TonometerDiagnostic test
iCare HOME tonometer is a device developed for patients/subjects to measure their eye pressure at home.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Standard Automatic Perimetry Humphrey Field Analyzer; Diagnostic Test: visuALL H; Diagnostic Test: iCare Home Tonometer; Diagnostic Test: Spectralis Optical coherence tomography (OCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 15 minutes daily over 1 week, 8 times for 2 years
Secondary outcomes (1)
Change in Visual Field Mean Deviation with Humphrey Field Analyzer
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 measured in the office by Humphrey perimeter 24-2 SITA standard per 3 times at baseline and then every 6 months during a 2 year period..
Measured: 2 hours, 5 times for 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start15 Apr 2022
- Primary completion17 Aug 2026
- Study completion17 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M. Reza Razeghinejad MD, Wills Eye
- Investigators
- M. Reza Razeghinejad, MD, Principal investigator, Wills Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325996
- Sponsor's protocol ID
- IRB# 2021-79
- Status last verified
- Aug 2026
- First submitted
- 25 Mar 2022
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Effectiveness of Home Testing Devises for Assisting in Management of Glaucoma Outside a Clinical Setting During a 2 Year Period.
- ClinicalTrials.gov ID
- NCT05325996
- Acronym / sponsor ID
- IRB# 2021-79
- Conditions
- Glaucoma, Open-Angle
- Keywords
- Open Angle Glaucoma, Perimetery, Tonometry, Eye Pressure, Visual Field, Home Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 17 Aug 2026 (actual)
- Study completion
- 17 Aug 2026 (actual)
- First posted
- 13 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moderate Glaucoma | Experimental | Diagnostic Test: Standard Automatic Perimetry Humphrey Field Analyzer, Diagnostic Test: visuALL H, Diagnostic Test: iCare Home Tonometer, Diagnostic Test: Spectralis Optical coherence tomography (OCT)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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Automatic Perimetry Humphrey Field AnalyzerAlso: SAP HFAStandard Automatic Perimetry (SAP) using the Swedish Interactive Threshold Algorithm (SITA) Standard Strategy measures the visual field in an ophthalmic setting. | Diagnostic test | Moderate Glaucoma |
| visuALL HvisuALL H a new portable perimeter measuring the visual field and acuity in a non ophthalmic setting. | Diagnostic test | Moderate Glaucoma |
| iCare Home TonometeriCare HOME tonometer is a device developed for patients/subjects to measure their eye pressure at home. | Diagnostic test | Moderate Glaucoma |
| 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. | Diagnostic test | Moderate Glaucoma |
Primary outcome
Change in Visual Field Mean Deviation with VisuALL
Time frame: 12 minutes each week for 104 weeks
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.
Change in Intraocular Pressure with iCare
Time frame: 15 minutes daily over 1 week, 8 times for 2 years
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.
1 secondary outcome
Change in Visual Field Mean Deviation with Humphrey Field Analyzer
Time frame: 2 hours, 5 times for 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Reza Razeghinejad, MD principal investigator
Wills Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Automatic Perimetry Humphrey Field Analyzer, visuALL H and iCare Home Tonometer in people with Glaucoma, Open-Angle, run by Wills Eye at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Field Mean Deviation with VisuALL (time frame: 12 minutes each week for 104 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.