One Eye BlindnessNCT06027216
Multiplexing Prism Fitting for Field Expansion of Monocular Vision
A study testing Multiplexing Prism in people with One Eye Blindness and Blind Left Eye, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
Trial summary
The investigators are developing an assistive device, known as multiplexing prism that expands the field of view for individuals with acquired monocular vision (loss of an eye). The investigators are testing a simplified design and fitting protocol to provide field expansion for individuals with acquired monocular… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- One Eye Blindness, Blind Left Eye, Blind Right Eye
- What is being tested?
- Multiplexing Prism
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Dec 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- No medical health issues such as seizures, motor movements problem
- Loss of vision in one eye (less than 20/200) for >1 year)
- Visual acuity of the seeing eye: Better than 20/32 visual acuity with correction
- No visual field defect in the seeing eye (nasal field of at least >45degree)
- No medical health issues such as seizures, motor movements problem
Who cannot join
- Patients with any physical or mental disabilities, including cognitive dysfunction, balance problems, or other deficits that could impair their ability to respond to the stimuli presented in this study will be excluded
- Any person with motor movements problem (e.g., unable to use extremities)
Trial locations and contacts
1 site in 1 country.
United States1 site
Schepens Eye Research Institute
Boston, Massachusetts, 02114
About this study
Official title: Monocular Visual Confusion for Field Expansion
The investigators are developing an assistive device, known as multiplexing prism that expands the field of view for individuals with acquired monocular vision (loss of an eye). The investigators are testing a simplified design and fitting protocol to provide field expansion for individuals with acquired monocular vision.
- Conditions
- One Eye Blindness, Blind Left Eye, Blind Right Eye
- Being tested
- Multiplexing Prism
- Keywords
- Field expansion, Collision detection, Walking, Response time
- Medical subject headings
- Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiplexing PrismDevice
Multiplexing prism is designed for spatial vision multiplexing. It allows partial light transmission through the prism allow the observer to simultaneously see the physical world through the prism and see the "shifted view" from the non-seeing side. It is developed to expand the field of view of individuals with just one eye.
| Study group | Role | What they receive |
|---|---|---|
| Field Expansion | Experimental | Field of view on the nasal side (same side as the blind eye) with and without multiplexing prism Receives: Device: Multiplexing Prism |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gain in Visual Field With the Multiplexing Prism
Field expansion is calculated based on the difference of the maximum field of view on the nasal side of the seeing/functioning eye (same side as the blind eye) with and without multiplexing prism.
Measured: Visit 2 of Study (approximately 2-3 weeks after 1st Visit)
Secondary outcomes (1)
Maximum Extent of Nasal Visual Field With the Multiplexing Prism
The farthest extent of the nasal visual field with the multiplexing prism placed in front of the seeing eye.
Measured: Visit 2 of Study (approximately 2-3 weeks after 1st Visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start27 Dec 2023
- Primary completion22 Oct 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for One Eye BlindnessStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Individuals with Acquired Monocular Vision/ Blindness in One Eye
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Principal investigator, Eli Peli, Massachusetts Eye and Ear Infirmary
- Investigators
- Eli Peli, OD, Principal investigator, Schepens Eye Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027216
- Sponsor's protocol ID
- 2023P001878
- Other IDs
- R01EY031777
- Status last verified
- Apr 2025
- First submitted
- 29 Aug 2023
- Last updated
- 8 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jung JH, Peli E. Field Expansion for Acquired Monocular Vision Using a Multiplexing Prism. Optom Vis Sci. 2018 Sep;95(9):814-828. doi: 10.1097/OPX.0000000000001277.
PubMed 30169357Jung JH, Peli E. No Useful Field Expansion with Full-field Prisms. Optom Vis Sci. 2018 Sep;95(9):805-813. doi: 10.1097/OPX.0000000000001271.
PubMed 30169356Peli E, Jung JH. Multiplexing Prisms for Field Expansion. Optom Vis Sci. 2017 Aug;94(8):817-829. doi: 10.1097/OPX.0000000000001102.
PubMed 28727615
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocular Visual Confusion for Field Expansion
- ClinicalTrials.gov ID
- NCT06027216
- Acronym / sponsor ID
- 2023P001878
- Conditions
- One Eye Blindness, Blind Left Eye, Blind Right Eye
- Keywords
- Field expansion, Collision detection, Walking, Response time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- 22 Oct 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 7 Sep 2023 (actual)
- Results
- Posted 8 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are developing an assistive device, known as multiplexing prism that expands the field of view for individuals with acquired monocular vision (loss of an eye). The investigators are testing a simplified design and fitting protocol to provide field expansion for individuals with acquired monocular vision.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Individuals with Acquired Monocular Vision/ Blindness in One Eye
| Arm | Type | Receives |
|---|---|---|
| Field Expansion | Experimental | Device: Multiplexing PrismField of view on the nasal side (same side as the blind eye) with and without multiplexing prism |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- No medical health issues such as seizures, motor movements problem
- Loss of vision in one eye (less than 20/200) for >1 year)
- Visual acuity of the seeing eye: Better than 20/32 visual acuity with correction
- No visual field defect in the seeing eye (nasal field of at least >45degree)
- No medical health issues such as seizures, motor movements problem
Key exclusion criteria (2 listed)
- Patients with any physical or mental disabilities, including cognitive dysfunction, balance problems, or other deficits that could impair their ability to respond to the stimuli presented in this study will be excluded
- Any person with motor movements problem (e.g., unable to use extremities)
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 |
|---|---|---|
| Multiplexing PrismMultiplexing prism is designed for spatial vision multiplexing. It allows partial light transmission through the prism allow the observer to simultaneously see the physical world through the prism and see the "shifted view" from the non-seeing side. It is developed to expand the field of view of individuals with just one eye. | Device | Field Expansion |
Primary outcome
Gain in Visual Field With the Multiplexing Prism
Time frame: Visit 2 of Study (approximately 2-3 weeks after 1st Visit)
Field expansion is calculated based on the difference of the maximum field of view on the nasal side of the seeing/functioning eye (same side as the blind eye) with and without multiplexing prism.
1 secondary outcome
Maximum Extent of Nasal Visual Field With the Multiplexing Prism
Time frame: Visit 2 of Study (approximately 2-3 weeks after 1st Visit)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30169357Jung JH, Peli E. Field Expansion for Acquired Monocular Vision Using a Multiplexing Prism. Optom Vis Sci. 2018 Sep;95(9):814-828. doi: 10.1097/OPX.0000000000001277.
- Background: PubMed 30169356Jung JH, Peli E. No Useful Field Expansion with Full-field Prisms. Optom Vis Sci. 2018 Sep;95(9):805-813. doi: 10.1097/OPX.0000000000001271.
- Background: PubMed 28727615Peli E, Jung JH. Multiplexing Prisms for Field Expansion. Optom Vis Sci. 2017 Aug;94(8):817-829. doi: 10.1097/OPX.0000000000001102.
- Individual participant dataSharing planned: No
Related trials for One Eye Blindness
Not yet recruiting
Health Education vs Meditation in Irreversible Age-Related Vision Loss Patients and Their Caregivers
Low Vision, One Eye, Unspecified Eye, Low Vision Blindness
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.
Eli Peli, OD principal investigator
Schepens Eye Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiplexing Prism in people with One Eye Blindness and Blind Left Eye, run by Massachusetts Eye and Ear Infirmary 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 5 inclusion and 2 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 8 May 2025. 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?
Yes. Results are posted in the registry (first posted 8 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Gain in Visual Field With the Multiplexing Prism (time frame: Visit 2 of Study (approximately 2-3 weeks after 1st Visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06027216, which also lists 3 linked publications.
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 8 May 2025.