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Homonymous HemianopsiaNCT07185971

PAVE (Parallactic Visual-Field Enhancement) System for Treatment of Chronic Visual Field Loss Due to Stroke, Traumatic Brain Injury, or Brain Surgery

A study testing PAVE (Parallactic Visual-Field Enhancement) treatment using a virtual reality head mounted display in people with Homonymous Hemianopsia and Homonymous Quadrantanopia, run by NeuroAEye LLC at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a research study to evaluate the effectiveness of the PAVE (Parallactic Visual-Field Enhancement) System for the treatment of chronic visual field loss due to stroke, traumatic brain injury, or brain surgery. Read more about this study

Who is it for?
Ages 21 to 80 years
What is being tested?
PAVE (Parallactic Visual-Field Enhancement) treatment using a virtual reality head mounted display
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesUnited States
Study dates
16 Mar 2026to Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 21 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • This study will include patients at least 6 months after the CVA or TBI or brain surgery event and up to ten (10) years after onset
  • The patients shall have a definitive diagnosis of homonymous hemianopia or quadrantanopia or generalized constriction.

Who cannot join

  • Presence of any physical, neurological, or mental disability that would interfere with receiving the therapy.
  • Concurrent use of another visual therapy
  • Concurrent use of medications judged to affect training (amphetamines, dopamine, etc.)
  • Presence of ocular or neurological conditions that would interfere with training or cause a visual impairment including no residual vision, disorders of the eye, non-optic nerve heteronymous visual field defects
  • Insufficient fixation ability
  • Use of life supporting external medical device such as infusion pumps, ventricular assist devices, etc.
Show all 10Show fewer
  • Presence of active implantable medical device including but not limited to cardiac pacemakers, defibrillators, nerve stimulators, cochlear implants, etc.
  • Subjects with known photosensitive epilepsy.
  • Subjects with chronic active infections on the head and face should be excluded from the study
  • Patients with known immune disorders for whom an infection could be life threatening should be excluded from the study.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Michael Lynch, BSME contact

315-730-9842

michael.lynch@neuroaeye.com

Paige Clinical Study Coordinator contact

319-366-3500

paige.eyecare@gmail.com

United States2 sites, 2 recruiting
  • Dr. D. M. Fitzgerald & Associates

    Cedar Rapids, Iowa, 52404

    Paige Primary Study Coordinator, 319-366-3500, paige.eyecare@gmail.com

    Larissa Study Coordinator, Larissabisig@gmail.com

    Recruiting
  • Neuro-Vision Associates of North Texas

    Prospect, Kentucky, 40059

    MIchael Lynch, BSME, 502-362-1109, michael.lynch@neuroaeye.com

    Amir Masoud, O.D., 973-312-0177, dr-amir@dr-s.net

    Recruiting

Other trials in United States

About this study

Official title: PAVE (Parallactic Visual-Field Enhancement) System for Treatment of Chronic Visual Field Loss

This is a research study to evaluate the effectiveness of the PAVE (Parallactic Visual-Field Enhancement) System for the treatment of chronic visual field loss due to stroke, traumatic brain injury, or brain surgery. The PAVE regimen involves the use of a virtual reality headset to deliver visual stimulation to subjects diagnosed with visual field loss.

The primary objective is to demonstrate that there is an improvement in the visual field after use of the PAVE therapy over a period of eight weeks with three sessions per week. The primary outcome is an increase in visual field area as measured with Goldmann-type kinetic perimetry.

Read more

The secondary outcome will be demonstration that the subjective assessment of visual function using the National Eye Institute Visual Function Questionnaire (NEI-VFQ) is better after PAVE therapy when compared to before therapy.

The participants will visit the investigators office at the start of the study to establish a baseline for visual field size and visual field function. The subject will use PAVE in the office or at home three times per week for eight weeks. There will be twenty four therapy sessions in total. At four weeks the subject will visit the office and have perimetry measurements. At eight weeks the subject will visit the office and have perimetry measurements and complete the NEI-VFQ survey. Four weeks after the completion of the therapy sessions a follow up visit will take place where visual field measurement using kinetic perimetry and NEI-VFQ will be administered.

Read the detailed description

This clinical investigation will focus on patients with chronic visual field loss following a cerebrovascular accident (CVA), a traumatic brain injury (TBI), or surgery of the brain. The CVA and TBI and some surgeries of the brain may affect bilateral visual fields (homonymous hemianopia, quadrantanopia, or general constriction). While perimetric visual field improvements can occur spontaneously in the first few months after brain injury, after six months the condition is considered chronic and permanent .

This study will include patients at least 6 months after the brain injury event and up to ten years after onset. If available for the study, patients suffering field loss as a result of brain surgery may also be enrolled. All patients shall have a definitive diagnosis of homonymous hemianopia, quadrantanopia, or general constriction. The patients shall have the ability to wear the virtual reality head mounted display HMD for a 30-minute session performed in the clinic at least once per week. Patients will be between 21 and 80 years of age. The clinical study shall be comprised of a single arm with all subjects receiving therapy with the PAVE software on the HMD. The initial sample size will be a minimum of fifteen. Performance will be evaluated using a semiautomated kinetic perimeter (SKP) measurement derived from the Goldmann method.

The goal will be to determine the amount of statistically significant improvement of the visual field for the subjects. Additional endpoints will include the percentage of subjects showing improvement and subjective assessment of the subject's visual performance using the National Eye Institute Visual Functioning Questionnaire (NEI-VFQ).

Being tested
PAVE (Parallactic Visual-Field Enhancement) treatment using a virtual reality head mounted display
Keywords
PAVE, Parallactic Visual-Field Enhancement, NeuroAEye, chronic visual field loss
Medical subject headings
Hemianopsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PAVE (Parallactic Visual-Field Enhancement) treatment using a virtual reality head mounted displayDevice

    PAVE (Parallactic Visual-Field Enhancement) treatment is visual stimulation using a virtual reality head mounted display. The treatment is three times per week and entails two 7 minute sessions separated by a minimum 1 minute intermission. The actual therapy is preceded by a visual field assessment and is followed by a second visual field assessment.

Study groups in NCT07185971
Study groupRoleWhat they receive
TestExperimentalTreatment using actual PAVE therapy software operating on a virtual reality head mounted display three times per week for eight weeks.
Receives: Device: PAVE (Parallactic Visual-Field Enhancement) treatment using a virtual reality head mounted display

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Population Mean Change in Visual Field Area

    The visual field area is derived from the isopter plot output of semiautomated kinetic perimetry. A baseline visual field area will be taken and subsequent measurements will be compared to the baseline.

    Measured: Visual field area will be assessed at the baseline, week 4, week 8, and follow up at week 12.

Secondary outcomes (1)
  1. Proportion of subjects showing improvement.

    The percentage of the subjects that demonstrates improvement when compared to the mean change in field of view area for the control group.

    Measured: The proportion of the subjects showing improvement will be assessed at week 4, week 8, and at the follow up at week 12.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2025
  2. Study start16 Mar 2026
  3. Primary completionJul 2026 (estimated)
  4. Study completionAug 2026 (estimated)

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single arm study - all subjects receive treatment.
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07185971
Sponsor's protocol ID
CLN001 Version 2.0
Status last verified
Mar 2026
First submitted
11 Sep 2025
Last updated
2 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • Zahid S, Peeler C, Khan N, Davis J, Mahmood M, Heckenlively JR, Jayasundera T. Digital quantification of Goldmann visual fields (GVFs) as a means for genotype-phenotype comparisons and detection of progression in retinal degenerations. Adv Exp Med Biol. 2014;801:131-7. doi: 10.1007/978-1-4614-3209-8_17.

    PubMed 24664690
  • Pe'er J, Zajicek G, Barzel I. Computerised evaluation of visual fields. Br J Ophthalmol. 1983 Jan;67(1):50-3. doi: 10.1136/bjo.67.1.50. No abstract available.

    PubMed 6848135
  • Barry MP, Bittner AK, Yang L, Marcus R, Iftikhar MH, Dagnelie G. Variability and Errors of Manually Digitized Goldmann Visual Fields. Optom Vis Sci. 2016 Jul;93(7):720-30. doi: 10.1097/OPX.0000000000000869.

    PubMed 27058594
  • Christoforidis JB. Volume of visual field assessed with kinetic perimetry and its application to static perimetry. Clin Ophthalmol. 2011;5:535-41. doi: 10.2147/OPTH.S18815. Epub 2011 Apr 26.

    PubMed 21573042
  • Bittner AK, Iftikhar MH, Dagnelie G. Test-retest, within-visit variability of Goldmann visual fields in retinitis pigmentosa. Invest Ophthalmol Vis Sci. 2011 Oct 11;52(11):8042-6. doi: 10.1167/iovs.11-8321.

    PubMed 21896857
  • Rowe FJ, Hepworth LR, Hanna KL, Mistry M, Noonan CP. Accuracy of kinetic perimetry assessment with the Humphrey 850; an exploratory comparative study. Eye (Lond). 2019 Dec;33(12):1952-1960. doi: 10.1038/s41433-019-0520-1. Epub 2019 Jul 22.

    PubMed 31332292
  • Barnes CS, Schuchard RA, Birch DG, Dagnelie G, Wood L, Koenekoop RK, Bittner AK. Reliability of Semiautomated Kinetic Perimetry (SKP) and Goldmann Kinetic Perimetry in Children and Adults With Retinal Dystrophies. Transl Vis Sci Technol. 2019 Jun 11;8(3):36. doi: 10.1167/tvst.8.3.36. eCollection 2019 May.

    PubMed 31211001
  • Goodwin D. Homonymous hemianopia: challenges and solutions. Clin Ophthalmol. 2014 Sep 22;8:1919-27. doi: 10.2147/OPTH.S59452. eCollection 2014.

    PubMed 25284978
  • Grunda T, Marsalek P, Sykorova P. Homonymous hemianopia and related visual defects: Restoration of vision after a stroke. Acta Neurobiol Exp (Wars). 2013;73(2):237-49. doi: 10.55782/ane-2013-1933.

    PubMed 23823985
  • Bouwmeester L, Heutink J, Lucas C. The effect of visual training for patients with visual field defects due to brain damage: a systematic review. J Neurol Neurosurg Psychiatry. 2007 Jun;78(6):555-64. doi: 10.1136/jnnp.2006.103853. Epub 2006 Nov 29.

    PubMed 17135455
  • Gall C, Sabel BA. Reading performance after vision rehabilitation of subjects with homonymous visual field defects. PM R. 2012 Dec;4(12):928-35. doi: 10.1016/j.pmrj.2012.08.020. Epub 2012 Nov 2.

    PubMed 23122896
  • Poggel DA, Mueller I, Kasten E, Bunzenthal U, Sabel BA. Subjective and objective outcome measures of computer-based vision restoration training. NeuroRehabilitation. 2010;27(2):173-87. doi: 10.3233/NRE-2010-0594.

    PubMed 20871147
  • Kasten E, Bunzenthal U, Sabel BA. Visual field recovery after vision restoration therapy (VRT) is independent of eye movements: an eye tracker study. Behav Brain Res. 2006 Nov 25;175(1):18-26. doi: 10.1016/j.bbr.2006.07.024. Epub 2006 Sep 12.

    PubMed 16970999
  • Mueller I, Mast H, Sabel BA. Recovery of visual field defects: a large clinical observational study using vision restoration therapy. Restor Neurol Neurosci. 2007;25(5-6):563-72.

    PubMed 18334773
  • Gall C, Mueller I, Gudlin J, Lindig A, Schlueter D, Jobke S, Franke GH, Sabel BA. Vision- and health-related quality of life before and after vision restoration training in cerebrally damaged patients. Restor Neurol Neurosci. 2008;26(4-5):341-53.

    PubMed 18997310

Questions about this trial

What is this clinical trial studying?

A study testing PAVE (Parallactic Visual-Field Enhancement) treatment using a virtual reality head mounted display in people with Homonymous Hemianopsia and Homonymous Quadrantanopia, run by NeuroAEye LLC at 2 sites 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 2 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michael Lynch, BSME (315-730-9842, michael.lynch@neuroaeye.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Population Mean Change in Visual Field Area (time frame: Visual field area will be assessed at the baseline, week 4, week 8, and follow up at week 12.). 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 NCT07185971, which also lists 28 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 2 Apr 2026.

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