Age-Related Macular DegenerationGA-001NCT06241625
Virtual Reality Based Vision Test in Patients With AMD
A study testing Virtual Reality (VR) Contrast Function Test in people with Age-Related Macular Degeneration, run by Augenklinik Zurich West at 1 site in Switzerland.
Trial summary
To assess the usability, tolerability, and repeatability of the set of VR headset-based tasks. Read more about this study
- Who is it for?
- Ages 50 to 105 years
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- Virtual Reality (VR) Contrast Function Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Oct 2022to Jul 2024
- 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 50 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects ≥18 years of age diagnosed with AMD
- Subject Snellen BCVA score is 20/100 or better
- Ability to undergo quality optical coherence tomography (OCT) imaging
- Willing and able to give written informed consent
Who cannot join
- Unwilling to use headset
- Previous negative experience with a VR headset (eg, motion sickness, discomfort)
- Any known oculomotor impairment that would impact the ability of the subject to perform the tasks (eg, nystagmus, proptosis, apraxia of eyelid opening)
- Any manifest neurological or cognitive condition that would impair the subject's understanding or performance on the test (eg, Alzheimer's disease, Parkinson's disease)
- Any physical limitations that would prohibit the use of the VR headset (eg, neck problems)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Augenklinik Zurich West
Zurich, Canton of Zurich, 8047
Stephan Michels, MD, +414454517 ext. 00, info@augenklinik-zh.ch
About this study
Official title: Virtual Reality (VR) Based Vision Test in Subjects With Age-related Macular Degeneration (AMD)
To assess the usability, tolerability, and repeatability of the set of VR headset-based tasks.
Read the detailed description
In order to bridge the gap between the existing functional measures and AMD lesions, researchers are considering the use of VR tools.
This study is designed to assess the contrast sensitivity function mapping test (CSF radial sweep) in an elderly population with AMD.
The primary objective of this study is to assess the usability, tolerability, and repeatability of the set of VR headset-based tasks.
The secondary objective of this study is to assess the relationship between the metrics generated by VR-based functional tasks and the metrics derived from conventional clinical measurements of retinal anatomy and visual function.
The primary efficacy endpoint is the Contrast sensitivity function (CSF) area under curve (AUC) correlation to Snellen BCVA.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- Virtual Reality (VR) Contrast Function Test
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality (VR) Contrast Function TestDiagnostic test
Patients perform a new Virtual Reality (VR) Contrast Function Test
| Study group | Role | What they receive |
|---|---|---|
| VR-Visual Function Test | Experimental | Assessment of virtual reality based vision function in Patients with AMD Receives: Diagnostic Test: Virtual Reality (VR) Contrast Function Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability, tolerability and repeatability
The primary objective of this study is to assess the usability, tolerability, and repeatability of the set of VR headset-based tasks. To assess the usability and tolerability a patient survey is performed.
Measured: 20 minutes
Secondary outcomes (1)
Contrast sensitivity function (CSF)
Contrast sensitivity function (CSF) in decibel as area under curve (AUC). The CSF is also correlated to Snellen best corrected visual acuity (BCVA)
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start20 Oct 2022
- Primary completionFeb 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augenklinik Zurich West
- Sponsor type
- University, hospital or other
- Collaborators
- Apellis Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Stephan Michels, MD, Principal investigator, Augenklinik Zurich West
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241625
- Sponsor's protocol ID
- APL-GA-001
- Acronym
- GA-001
- Status last verified
- Aug 2023
- First submitted
- 5 Jan 2023
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality (VR) Based Vision Test in Subjects With Age-related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT06241625
- Acronym / sponsor ID
- GA-001 / APL-GA-001
- Conditions
- Age-Related Macular Degeneration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Augenklinik Zurich WestUniversity, hospital or other
- Collaborators
- Apellis Pharmaceuticals, Inc.
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 5 Feb 2024 (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.
To assess the usability, tolerability, and repeatability of the set of VR headset-based tasks.
Detailed description
In order to bridge the gap between the existing functional measures and AMD lesions, researchers are considering the use of VR tools.
This study is designed to assess the contrast sensitivity function mapping test (CSF radial sweep) in an elderly population with AMD.
The primary objective of this study is to assess the usability, tolerability, and repeatability of the set of VR headset-based tasks.
The secondary objective of this study is to assess the relationship between the metrics generated by VR-based functional tasks and the metrics derived from conventional clinical measurements of retinal anatomy and visual function.
The primary efficacy endpoint is the Contrast sensitivity function (CSF) area under curve (AUC) correlation to Snellen BCVA.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VR-Visual Function Test | Experimental | Diagnostic Test: Virtual Reality (VR) Contrast Function TestAssessment of virtual reality based vision function in Patients with AMD |
Who may qualify
- Ages
- 50 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects ≥18 years of age diagnosed with AMD
- Subject Snellen BCVA score is 20/100 or better
- Ability to undergo quality optical coherence tomography (OCT) imaging
- Willing and able to give written informed consent
Key exclusion criteria (5 listed)
- Unwilling to use headset
- Previous negative experience with a VR headset (eg, motion sickness, discomfort)
- Any known oculomotor impairment that would impact the ability of the subject to perform the tasks (eg, nystagmus, proptosis, apraxia of eyelid opening)
- Any manifest neurological or cognitive condition that would impair the subject's understanding or performance on the test (eg, Alzheimer's disease, Parkinson's disease)
- Any physical limitations that would prohibit the use of the VR headset (eg, neck problems)
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 |
|---|---|---|
| Virtual Reality (VR) Contrast Function TestPatients perform a new Virtual Reality (VR) Contrast Function Test | Diagnostic test | VR-Visual Function Test |
Primary outcome
Usability, tolerability and repeatability
Time frame: 20 minutes
The primary objective of this study is to assess the usability, tolerability, and repeatability of the set of VR headset-based tasks. To assess the usability and tolerability a patient survey is performed.
1 secondary outcome
Contrast sensitivity function (CSF)
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- 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.
Stephan Michels, MD principal investigator
Augenklinik Zurich West
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality (VR) Contrast Function Test in people with Age-Related Macular Degeneration, run by Augenklinik Zurich West at 1 site in Switzerland.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Feb 2024. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephan Michels, MD (+414454517 ext. 00, info@augenklinik-zh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability, tolerability and repeatability (time frame: 20 minutes). 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 5 Feb 2024.