" Visual Characterization of Parkinson's Patients and Oculomotor or Perceptual Therapy"

NCT06032130 | Completed

• 1 other identifier: 2161984
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Parkinson's disease (PD) is the second most common neurodegenerative condition worldwide, characterised by motor symptoms, but with other symptoms such as visual impairment. The aim is to compare visual function between PD patients and healthy subjects in order to adequately characterise the visual capabilities of the PD population and perform oculomotor or perceptual therapy to find optometric solutions to slow down the visual impairment they suffer from or minimise their visual symptoms. In the first phase, non-invasive tests will be carried out, such as measuring visual acuity, refraction, pupil diameter in different lighting conditions, sensory dominance, contrast sensitivity, colour vision, stereopsis, reading speed, binocular vision, eye movements and influence on quality of life. In the second, visual oculomotor or perceptual exercises will be performed in a group of PD patients to assess whether there is stabilisation of impairment or improvement of these visual skills. These will be performed in a non-invasive way using simple and easy-to-use instruments or an application on an electronic device could be used. Finally, in the third phase, those visual skills that have been treated will be re-evaluated to assess possible changes, compared with a group of PD patients who have not undergone the visual exercises.

Conditions

Parkinson Disease

Keywords

Parkinson's Disease; Vision; Ocular Motility Disorders; Perceptual Disorders

Outcome Measures

Primary Outcomes (12)

• Anamnesis

  Ocular and perceptual characterization of Parkinson's Disease visual capabilities with the following measurements (1-12). Anamnesis: Asking age, allergies, ocular and systemic pathologies, family background, current treatment (if proceed), consumption of tobacco, alcohol, drugs, coffee, tea, performance of physical activity, state on the Hoehn \& Yahr classification, date of Parkinson's diagnosis and other observations.

  1 year

• Visual Acuity

  Using an EDTRS (Early Treatment Diabetic Retinopathy Study) test for distance and near vision with the patient's optical correction, scale: LogMAR.

  1 year

• Refraction

  Doing ocular compensation with trial frame refraction, units: diopters (D).

  1 year

• Pupillary diameter

  Under photopic and mesopic illumination conditions using a specific millimetric ruler, units: millimeters (mm).

  1 year

• Ocular sensory dominance

  Using the red filter test.

  1 year

• Binocular vision status

  Using the Cover Test Cover Test, Modified Thorington Test Card to phoria measurement and fusional vergence measurement with prism bar, units: prismatic diopters (Δ).

  1 year

• Achromatic CSF (Contrast Sensitivity Funtion)

  Under photopic and mesopic illumination conditions using the FACT (Funtional Acuity Contrast Test) test of the FVA (Functional Visual Analyzer) device of Stereo Optical Co., Inc.

  1 year

• Stereopsis

  Using the Wirth points of the Titmus test, units: seconds of arc (").

  1 year

• Colour vision

  Using the Farnsworth-Munsell 100 Hue sorting test and the Chromatic Threshold Measurement test.

  1 year

• Eye movements quality

  Using aDEMd (adult Developmental Eye Movement with distractors) test and NSUCO (Northeastern State University College of Optometry) test. Units: seconds (s).

  1 year

• Reading speed

  Using Radner-Vissum test, units: seconds (s).

  1 year

• Life quality assessment

  Scoring the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25). Higher scores mean a better outcome. Minimum value: 0, maximum value: 100.

  1 year

Secondary Outcomes (3)

• Pursuit eye movements

  1 year

• Saccadic eye movements

  1 year

• Perceptual learning technique

  1 year

Study Arms (4)

Parkinson Disease Group (PD)

1. Anamnesis 2. Measurement of best visual acuity with an EDTRS (Early Treatment Diabetic Retinopathy Study) test 3. Measurement of refraction with trial frame refraction 4. Measurement of pupillary diameter under photopic and mesopic illumination conditions using a specific millimetric ruler 5. Measurement of ocular sensory dominance with the red filter test 6. Measurement of binocular vision status with the Cover Test, prism bar and Maddox wing 7. Photopic and mesopic achromatic contrast sensitivity using the Functional Test Analyzer device 8. Stereopsis using the Titmus Test 9. Colour vision using the Farnsworth-Munsell 100 Hue sorting test 10. Measurement of eye movements with aDEMd (adult Developmental Eye Movement) test and NSUCO (Northeastern State University College of Optometry) 11. Measurement of reading speed with Radner-Vissum test 12. National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25)

Other: Clinical measurements

Control Group (GP)

1. Anamnesis: name, sex, date of birth, contact, family contact, medical report, Hoehn \& Yahr classification, medication, systemic, ocular and family history, consumption of tobacco, alcohol, drugs, coffee, physical activity, eye colour, other observations 2. Measurement of best visual acuity with an EDTRS test 3. Measurement of refraction with trial frame refraction 4. Measurement of pupillary diameter under photopic and mesopic illumination conditions using a specific millimetric ruler 5. Measurement of ocular sensory dominance with the red filter test 6. Measurement of binocular vision status with the Cover Test, prism bar and Maddox wing 7. Photopic and mesopic achromatic contrast sensitivity using the Functional Test Analyzer device 8. Stereopsis using the Titmus Test 9. Colour vision using the Farnsworth-Munsell 100 Hue sorting test 10. Measurement of eye movements with aDEMd test and NSUCO 11. Measurement of reading speed with Radner-Vissum test 12. NEI VFQ-25

Other: Clinical measurements

Therapy Parkinson Disease Group (TPD)

Oculomotor exercises such as tracking eye movements, saccadic eye movements and fixations will be performed. These exercises will be performed in a non-invasive manner using simple and easy-to-use instruments. An application on an electronic device, namely the virtual reality software Visionary, could also be used. If financial resources allow, the intention is to use tablets or computers for this purpose. Perceptual learning exercises will also be carried out on an electronic device. The following variables will be collected from these exercises: time taken to carry out the tests, errors made, speed of completion, latency, etc. These will be compared before and after the exercises in the third phase. In addition, the patients will be given indications for working on these exercises at home.

Other: Oculomotor or perceptual therapy

Control Parkinson Disease Group (CPD)

These patients will not receive oculomotor or perceptual therapy. They will be evaluated in the same manner as patients who will receive therapy, both at the beginning and at the end of therapy in the other group.

Other: Clinical measurements

Interventions

Clinical measurements OTHER

Optometric measurements

Control Group (GP); Control Parkinson Disease Group (CPD); Parkinson Disease Group (PD)

Oculomotor or perceptual therapy OTHER

Oculomotor or perceptual visual learning exercices

Therapy Parkinson Disease Group (TPD)

Eligibility Criteria

• Age: 30 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Parkinson's Disease.

You may qualify if:

• Subjects without neurodegenerative diseases or systemic illnesses or ocular pathologies.
• Subjects not taking medication with visual side effects.
• Subjects able to perform the tests.
• Subjects of similar age and sex as their corresponding Parkinson's patient so that both samples are age and gender matched.
• Subjects diagnosed with Parkinson's disease.
• Parkinson's patients classified according to the Hoehn \& Yahr Scale.

You may not qualify if:

• Subjects with ocular pathologies (such as Glaucoma, Age-Related Macular Degeneration, Retinopathies, Corneal Opacifications, Senile Cataracts, Severe Palpebral Ptosis) or systemic illnesses that may affect the visual system and alter the results (such as Severe Cardiopathies, Diabetes Mellitus, oncological diseases, systemic tissue disorders, chronic infectious diseases or conditions after organ or tissue transplantation).
• Subjects with neurodegenerative or neural diseases other than the study itself, such as Alzheimer's disease, Devic's disease, Huntington's disease, Creutzfeldt-Jakob disease, epilepsy, ataxia, multiple sclerosis or amyotrophic lateral sclerosis.
• Subjects taking medication that may alter any visual ability such as anxiolytics, antidepressants, sleeping pills.
• Subjects with problems in understanding and following the tests.
• Patients who have been previously treated under a vision therapy program.

Sponsors & Collaborators

• University of Valencia: lead
• Asociación Parkinson Valencia: collaborator
• Hospital Arnau de Vilanova: collaborator

Study Sites (1)

Hospital Arnau de Vilanova

Valencia, Valencia, 46015, Spain

Location

Related Publications (16)

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• Armstrong RA. Visual symptoms in Parkinson's disease. Parkinsons Dis. 2011;2011:908306. doi: 10.4061/2011/908306. Epub 2011 May 25.

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• Balestrino R, Schapira AHV. Parkinson disease. Eur J Neurol. 2020 Jan;27(1):27-42. doi: 10.1111/ene.14108. Epub 2019 Nov 27.

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  PMID: 22981772 BACKGROUND

• Borm CDJM, Visser F, Werkmann M, de Graaf D, Putz D, Seppi K, Poewe W, Vlaar AMM, Hoyng C, Bloem BR, Theelen T, de Vries NM. Seeing ophthalmologic problems in Parkinson disease: Results of a visual impairment questionnaire. Neurology. 2020 Apr 7;94(14):e1539-e1547. doi: 10.1212/WNL.0000000000009214. Epub 2020 Mar 11.

  PMID: 32161030 BACKGROUND

• Campbell FW, Robson JG. Application of Fourier analysis to the visibility of gratings. J Physiol. 1968 Aug;197(3):551-66. doi: 10.1113/jphysiol.1968.sp008574.

  PMID: 5666169 BACKGROUND

• Ekker MS, Janssen S, Seppi K, Poewe W, de Vries NM, Theelen T, Nonnekes J, Bloem BR. Ocular and visual disorders in Parkinson's disease: Common but frequently overlooked. Parkinsonism Relat Disord. 2017 Jul;40:1-10. doi: 10.1016/j.parkreldis.2017.02.014. Epub 2017 Feb 21.

  PMID: 28284903 BACKGROUND

• Fahle M. Perceptual learning: a case for early selection. J Vis. 2004 Oct 26;4(10):879-90. doi: 10.1167/4.10.4.

  PMID: 15595892 BACKGROUND

• Gonzalez-Rodriguez P, Zampese E, Stout KA, Guzman JN, Ilijic E, Yang B, Tkatch T, Stavarache MA, Wokosin DL, Gao L, Kaplitt MG, Lopez-Barneo J, Schumacker PT, Surmeier DJ. Disruption of mitochondrial complex I induces progressive parkinsonism. Nature. 2021 Nov;599(7886):650-656. doi: 10.1038/s41586-021-04059-0. Epub 2021 Nov 3. Erratum In: Nature. 2022 Mar;603(7899):E1. doi: 10.1038/s41586-021-04382-6.

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• Han G, Han J, Han K, Youn J, Chung TY, Lim DH. Visual Acuity and Development of Parkinson's Disease: A Nationwide Cohort Study. Mov Disord. 2020 Sep;35(9):1532-1541. doi: 10.1002/mds.28184. Epub 2020 Jul 25.

  PMID: 32710579 BACKGROUND

• Huang CB, Zhou Y, Lu ZL. Broad bandwidth of perceptual learning in the visual system of adults with anisometropic amblyopia. Proc Natl Acad Sci U S A. 2008 Mar 11;105(10):4068-73. doi: 10.1073/pnas.0800824105. Epub 2008 Mar 3.

  PMID: 18316716 BACKGROUND

• Kaur M, Saxena R, Singh D, Behari M, Sharma P, Menon V. Correlation Between Structural and Functional Retinal Changes in Parkinson Disease. J Neuroophthalmol. 2015 Sep;35(3):254-8. doi: 10.1097/WNO.0000000000000240.

  PMID: 25807477 BACKGROUND

• Sasaki Y, Nanez JE, Watanabe T. Advances in visual perceptual learning and plasticity. Nat Rev Neurosci. 2010 Jan;11(1):53-60. doi: 10.1038/nrn2737. Epub 2009 Dec 2.

  PMID: 19953104 BACKGROUND

• Sasso P, Silvestri V, Sulfaro M, Scupola A, Fasciani R, Amore F. Perceptual learning in patients with Stargardt disease. Can J Ophthalmol. 2019 Dec;54(6):708-716. doi: 10.1016/j.jcjo.2019.03.012. Epub 2019 May 31.

  PMID: 31836104 BACKGROUND

• Savitt J, Aouchiche R. Management of Visual Dysfunction in Patients with Parkinson's Disease. J Parkinsons Dis. 2020;10(s1):S49-S56. doi: 10.3233/JPD-202103.

  PMID: 32741840 BACKGROUND

• Shibasaki H, Tsuji S, Kuroiwa Y. Oculomotor abnormalities in Parkinson's disease. Arch Neurol. 1979 Jun;36(6):360-4. doi: 10.1001/archneur.1979.00500420070009.

  PMID: 454234 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Ocular Motility Disorders; Perceptual Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cranial Nerve Diseases; Eye Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• María Amparo Díez-Ajenjo, PhD

  University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: September 11, 2023
• Study Start: November 2, 2023
• Primary Completion: April 10, 2024
• Study Completion: April 8, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)