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

Официальное название

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

Обзор

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. 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.

Подробное описание

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).

Вмешательства

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

Первичные конечные точки

• Population Mean Change in Visual Field Area [Срок оценки: Visual field area will be assessed at the baseline, week 4, week 8, and follow up at week 12.]

Вторичные конечные точки (1)

• Proportion of subjects showing improvement. [Срок оценки: The proportion of the subjects showing improvement will be assessed at week 4, week 8, and at the follow up at week 12.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Dr. D. M. Fitzgerald & Associates — Cedar Rapids
• Neuro-Vision Associates of North Texas — Prospect

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 31211001
• Goodwin D. Homonymous hemianopia: challenges and solutions. Clin Ophthalmol. 2014 Sep 22;8:1919-27. doi: 10.2147/OPTH.S59452. eCollection 2014. PMID 25284978

Идентификаторы

NCT: NCT07185971 · CLN001 Version 2.0

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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