xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06032130</url>
    </required_header>
    <id_info>
      <org_study_id>2161984</org_study_id>
      <nct_id>NCT06032130</nct_id>
    </id_info>
    <brief_title>&quot; Visual Characterization of Parkinson's Patients and Oculomotor or Perceptual Therapy&quot;</brief_title>
    <official_title>&quot;Characterization of Visual Problems in Patients With Parkinson's Disease and Application of an Oculomotor and/or Perceptual Therapy Program&quot;</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Valencia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Asociación Parkinson Valencia</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Hospital Arnau de Vilanova</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Valencia</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Parkinson's disease (PD) is the second most common neurodegenerative condition worldwide,&#xD;
        characterised by motor symptoms, but with other symptoms such as visual impairment.&#xD;
  &#xD;
        The aim is to compare visual function between PD patients and healthy subjects in order to&#xD;
        adequately characterise the visual capabilities of the PD population and perform oculomotor&#xD;
        or perceptual therapy to find optometric solutions to slow down the visual impairment they&#xD;
        suffer from or minimise their visual symptoms.&#xD;
  &#xD;
        In the first phase, non-invasive tests will be carried out, such as measuring visual acuity,&#xD;
        refraction, pupil diameter in different lighting conditions, sensory dominance, contrast&#xD;
        sensitivity, colour vision, stereopsis, reading speed, binocular vision, eye movements and&#xD;
        influence on quality of life.&#xD;
  &#xD;
        In the second, visual oculomotor or perceptual exercises will be performed in a group of PD&#xD;
        patients to assess whether there is stabilisation of impairment or improvement of these&#xD;
        visual skills. These will be performed in a non-invasive way using simple and easy-to-use&#xD;
        instruments or an application on an electronic device could be used.&#xD;
  &#xD;
        Finally, in the third phase, those visual skills that have been treated will be re-evaluated&#xD;
        to assess possible changes, compared with a group of PD patients who have not undergone the&#xD;
        visual exercises.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Parkinson's disease (PD) is the second most common neurodegenerative condition worldwide. It&#xD;
        is a movement disorder characterised by tremor, rigidity, bradykinesia and postural&#xD;
        instability. However, 78% of PD patients report visual problems such as dry eye, reduced&#xD;
        visual acuity, visual field defects, impaired contrast sensitivity (CS), impaired eye&#xD;
        movements, diplopia, convergence insufficiency, impaired colour vision, visual hallucinations&#xD;
        and problems in visual-spatial orientation. In fact, visual dysfunction is one of the initial&#xD;
        symptoms of PD. A recent study has found that dopaminergic neurons affected in PD show&#xD;
        physiological dysfunctions, but do not die. Currently, there is no cure for PD; treatments&#xD;
        consist of controlling symptoms, and the earlier the disease is detected and administered,&#xD;
        the more effective they are.&#xD;
  &#xD;
        It is hypothesised that a programme of visual oculomotor therapy and/or visual perceptual&#xD;
        learning (VPL) could slow or halt the deterioration of oculomotor ability and/or CS in these&#xD;
        patients. Visual perceptual learning or VPL is a long-term improvement in performance on a&#xD;
        visual task, any relatively permanent change in perception that arises from visual&#xD;
        experience. Contrast Sensitivity or CS is the ability of the visual system to differentiate&#xD;
        an object from the background in which it is located by the difference in contrast. It is the&#xD;
        ability to detect differences in luminance between adjacent areas in an image.&#xD;
  &#xD;
        If the results confirm the hypothesis, this study will have a great impact on the PD&#xD;
        population because it could slow down the deterioration of oculomotor ability that 75% of&#xD;
        them suffer from. It could also slow down the decline in CS that they suffer, as demonstrated&#xD;
        by several studies. Consequently, patients would also experience an improvement in their&#xD;
        quality of life, as they would be able to continue to perform activities of daily living that&#xD;
        are affected by visual impairment such as walking, reading, driving and cooking. This would&#xD;
        have a major impact on society as PD affects many people worldwide. In Europe, the prevalence&#xD;
        and incidence rates of PD are estimated to be approximately 108-257/100 000 and 11-19/100 000&#xD;
        per year, respectively. Furthermore, this project would expand scientific knowledge because&#xD;
        to date there is no literature that has evaluated VPL in patients with PD. However, there is&#xD;
        research on amblyopia, Stargardt's disease and other neural pathologies, such as Huntington's&#xD;
        disease. Likewise, with regard to oculomotor therapy, there is still a lot of research to be&#xD;
        done, as there are few studies on this subject.&#xD;
  &#xD;
        This is an analytical, longitudinal, prospective and observational study. In the first phase,&#xD;
        to characterise the vision of the population with Parkinson's disease, non-invasive tests&#xD;
        would be performed, such as measuring visual acuity, refraction, contrast sensitivity, colour&#xD;
        vision, depth vision, the state of binocular vision and visual pathways and eye movements.&#xD;
        Simultaneously, a control population will be measured to compare the data obtained in PD&#xD;
        patients.&#xD;
  &#xD;
        In a second phase, visual oculomotor and/or perceptual exercises would be performed in a&#xD;
        group of PD patients to assess whether there is stabilisation of the impairment and/or&#xD;
        improvement of these visual skills.&#xD;
  &#xD;
        Finally, in the third phase, those visual skills that have been treated would be re-evaluated&#xD;
        to assess possible changes, compared with a group of PD patients who have not undergone the&#xD;
        visual exercises.&#xD;
  &#xD;
        The research will be carried out at the Laboratory of Vision and Colour Sciences of the&#xD;
        Department of Optics, Optometry and Vision Sciences of the University of Valencia, at the&#xD;
        Arnau de Vilanova Hospital and at the Parkinson's Association of Valencia. These are the&#xD;
        institutions from which the participants who take part in the study will come. They will do&#xD;
        so voluntarily, will not be coerced to participate in any way and will be free to choose&#xD;
        whether they want to participate or not, after having been explained to them what this&#xD;
        project consists of. Furthermore, they will be able to revoke their signed consent at any&#xD;
        time, so that they will automatically be excluded from the study and their data will not be&#xD;
        used in the study if the patient so wishes. Furthermore, this project does not harm the&#xD;
        patient's health and does not bring any financial benefit to the patient.&#xD;
  &#xD;
        Only the members of the project will have access to the original study data. These data will&#xD;
        be collected on paper, and the original source will be kept under lock and key in the&#xD;
        laboratory of Vision and Colour Sciences of the Department of Optics, Optometry and Vision&#xD;
        Sciences of the University of Valencia. For data analysis, the principal investigator will&#xD;
        extract the data into a computer document in which each patient will be identified by a&#xD;
        two-letter code (GP: control group; PD: Parkinson's patient) and three numbers. Not even the&#xD;
        initials of the name will appear. Under this code, the data of each patient will be entered.&#xD;
        This is the data that the rest of the group will see and have access to. Adverse event&#xD;
        reporting and change management will be carried out through the Reservio platform, which will&#xD;
        be used for appointment planning and online booking.&#xD;
  &#xD;
        Data analysis will be carried out using the SPSS (Statistical Package for Social Sciences)&#xD;
        statistical software and the Matlab numerical calculation system. The statistical analysis&#xD;
        plan is as follows: the mean, standard deviation and normality of the samples will be&#xD;
        performed with the Shapiro-Wilk test. Statistical comparison between groups will be performed&#xD;
        with Student's t-test if the data follow a normal distribution or with the U-Mann-Whitney&#xD;
        test otherwise. The statistical test used for qualitative variables will be Pearson's&#xD;
        chi-square test.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 29, 2023</start_date>
    <completion_date type="Anticipated">June 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">June 1, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Anamnesis</measure>
      <time_frame>1 year</time_frame>
      <description>Ocular and perceptual characterization of Parkinson's Disease visual capabilities with the following measurements (1-12).&#xD;
  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 &amp; Yahr classification, date of Parkinson's diagnosis and other observations.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Visual Acuity</measure>
      <time_frame>1 year</time_frame>
      <description>Using an EDTRS (Early Treatment Diabetic Retinopathy Study) test for distance and near vision with the patient's optical correction, scale: LogMAR.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Refraction</measure>
      <time_frame>1 year</time_frame>
      <description>Doing ocular compensation with trial frame refraction, units: diopters (D).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pupillary diameter</measure>
      <time_frame>1 year</time_frame>
      <description>Under photopic and mesopic illumination conditions using a specific millimetric ruler, units: millimeters (mm).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Ocular sensory dominance</measure>
      <time_frame>1 year</time_frame>
      <description>Using the red filter test.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Binocular vision status</measure>
      <time_frame>1 year</time_frame>
      <description>Using the Cover Test Cover Test, Modified Thorington Test Card to phoria measurement and fusional vergence measurement with prism bar, units: prismatic diopters (Δ).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Achromatic CSF (Contrast Sensitivity Funtion)</measure>
      <time_frame>1 year</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Stereopsis</measure>
      <time_frame>1 year</time_frame>
      <description>Using the Wirth points of the Titmus test, units: seconds of arc (&quot;).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Colour vision</measure>
      <time_frame>1 year</time_frame>
      <description>Using the Farnsworth-Munsell 100 Hue sorting test and the Chromatic Threshold Measurement test.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Eye movements quality</measure>
      <time_frame>1 year</time_frame>
      <description>Using aDEMd (adult Developmental Eye Movement with distractors) test and NSUCO (Northeastern State University College of Optometry) test. Units: seconds (s).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Reading speed</measure>
      <time_frame>1 year</time_frame>
      <description>Using Radner-Vissum test, units: seconds (s).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Life quality assessment</measure>
      <time_frame>1 year</time_frame>
      <description>Scoring the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25). Higher scores mean a better outcome. Minimum value: 0, maximum value: 100.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pursuit eye movements</measure>
      <time_frame>1 year</time_frame>
      <description>Would be performed noninvasively using simple, easy-to-use instruments such as flashlights, pointers, slates, Marsden's ball, rotating devices and Groffman's visual tracing test. If financial resources permit, an application on an electronic device could also be used.&#xD;
  From these exercises, the following variables will be collected: time spent in the performance of the exercises in seconds (s) and errors made. These will be compared before and after the therapy.&#xD;
  In addition, the patients would be given indications for the work of these exercises at home.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Saccadic eye movements</measure>
      <time_frame>1 year</time_frame>
      <description>Would be performed noninvasively using simple, easy-to-use instruments such as flashlights, pointers, slates, Hart's charts, ARB charts and Ann Arbor tracing sheets. If financial resources permit, an application on an electronic device could also be used.&#xD;
  From these exercises, the following variables will be collected: time spent in the performance of the exercises in seconds (s) and errors made. These will be compared before and after the therapy.&#xD;
  In addition, the patients would be given indications for the work of these exercises at home.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceptual learning technique</measure>
      <time_frame>1 year</time_frame>
      <description>Perceptual learning exercises could also be performed on an electronic device with a program that displays Gabor patches. This technique consists of a task with low-contrast, progressively decreasing, sustained attention, demanding and repetitive stimuli.</description>
    </secondary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Anticipated">160</enrollment>
    <condition>Parkinson Disease</condition>
    <arm_group>
      <arm_group_label>Parkinson Disease Group (PD)</arm_group_label>
      <description>Anamnesis&#xD;
  Measurement of best visual acuity with an EDTRS (Early Treatment Diabetic Retinopathy Study) test&#xD;
  Measurement of refraction with trial frame refraction&#xD;
  Measurement of pupillary diameter under photopic and mesopic illumination conditions using a specific millimetric ruler&#xD;
  Measurement of ocular sensory dominance with the red filter test&#xD;
  Measurement of binocular vision status with the Cover Test, prism bar and Maddox wing&#xD;
  Photopic and mesopic achromatic contrast sensitivity using the Functional Test Analyzer device&#xD;
  Stereopsis using the Titmus Test&#xD;
  Colour vision using the Farnsworth-Munsell 100 Hue sorting test&#xD;
  Measurement of eye movements with aDEMd (adult Developmental Eye Movement) test and NSUCO (Northeastern State University College of Optometry)&#xD;
  Measurement of reading speed with Radner-Vissum test&#xD;
  National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group (GP)</arm_group_label>
      <description>Anamnesis: name, sex, date of birth, contact, family contact, medical report, Hoehn &amp; Yahr classification, medication, systemic, ocular and family history, consumption of tobacco, alcohol, drugs, coffee, physical activity, eye colour, other observations&#xD;
  Measurement of best visual acuity with an EDTRS test&#xD;
  Measurement of refraction with trial frame refraction&#xD;
  Measurement of pupillary diameter under photopic and mesopic illumination conditions using a specific millimetric ruler&#xD;
  Measurement of ocular sensory dominance with the red filter test&#xD;
  Measurement of binocular vision status with the Cover Test, prism bar and Maddox wing&#xD;
  Photopic and mesopic achromatic contrast sensitivity using the Functional Test Analyzer device&#xD;
  Stereopsis using the Titmus Test&#xD;
  Colour vision using the Farnsworth-Munsell 100 Hue sorting test&#xD;
  Measurement of eye movements with aDEMd test and NSUCO&#xD;
  Measurement of reading speed with Radner-Vissum test&#xD;
  NEI VFQ-25</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Therapy Parkinson Disease Group (TPD)</arm_group_label>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Parkinson Disease Group (CPD)</arm_group_label>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Clinical measurements</intervention_name>
      <description>Optometric measurements</description>
      <arm_group_label>Control Group (GP)</arm_group_label>
      <arm_group_label>Control Parkinson Disease Group (CPD)</arm_group_label>
      <arm_group_label>Parkinson Disease Group (PD)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Oculomotor or perceptual therapy</intervention_name>
      <description>Oculomotor or perceptual visual learning exercices</description>
      <arm_group_label>Therapy Parkinson Disease Group (TPD)</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with Parkinson's Disease.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subjects without neurodegenerative diseases or systemic illnesses or ocular&#xD;
               pathologies.&#xD;
  &#xD;
            -  Subjects not taking medication with visual side effects.&#xD;
  &#xD;
            -  Subjects able to perform the tests.&#xD;
  &#xD;
            -  Subjects of similar age and sex as their corresponding Parkinson's patient so that&#xD;
               both samples are age and gender matched.&#xD;
  &#xD;
            -  Subjects diagnosed with Parkinson's disease.&#xD;
  &#xD;
            -  Parkinson's patients classified according to the Hoehn &amp; Yahr Scale.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subjects with ocular pathologies (such as Glaucoma, Age-Related Macular Degeneration,&#xD;
               Retinopathies, Corneal Opacifications, Senile Cataracts, Severe Palpebral Ptosis) or&#xD;
               systemic illnesses that may affect the visual system and alter the results (such as&#xD;
               Severe Cardiopathies, Diabetes Mellitus, oncological diseases, systemic tissue&#xD;
               disorders, chronic infectious diseases or conditions after organ or tissue&#xD;
               transplantation).&#xD;
  &#xD;
            -  Subjects with neurodegenerative or neural diseases other than the study itself, such&#xD;
               as Alzheimer's disease, Devic's disease, Huntington's disease, Creutzfeldt-Jakob&#xD;
               disease, epilepsy, ataxia, multiple sclerosis or amyotrophic lateral sclerosis.&#xD;
  &#xD;
            -  Subjects taking medication that may alter any visual ability such as anxiolytics,&#xD;
               antidepressants, sleeping pills.&#xD;
  &#xD;
            -  Subjects with problems in understanding and following the tests.&#xD;
  &#xD;
            -  Patients who have been previously treated under a vision therapy program.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>María Amparo Díez-Ajenjo, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Valencia</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>María Amparo Díez-Ajenjo, PhD</last_name>
      <phone>(+34) 963 86 41 00</phone>
      <phone_ext>44170</phone_ext>
      <email>amparo.diez@uv.es</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Rosa María Hernández-Andrés, PhD</last_name>
      <phone>(+34) 963 86 41 00</phone>
      <phone_ext>44098</phone_ext>
      <email>rosa.m.hernandez@uv.es</email>
    </overall_contact_backup>
    <reference>
      <citation>Armstrong MJ, Okun MS. Diagnosis and Treatment of Parkinson Disease: A Review. JAMA. 2020 Feb 11;323(6):548-560. doi: 10.1001/jama.2019.22360.</citation>
      <PMID>32044947</PMID>
    </reference>
    <reference>
      <citation>Armstrong RA. Visual symptoms in Parkinson's disease. Parkinsons Dis. 2011;2011:908306. doi: 10.4061/2011/908306. Epub 2011 May 25.</citation>
      <PMID>21687773</PMID>
    </reference>
    <reference>
      <citation>Balestrino R, Schapira AHV. Parkinson disease. Eur J Neurol. 2020 Jan;27(1):27-42. doi: 10.1111/ene.14108. Epub 2019 Nov 27.</citation>
      <PMID>31631455</PMID>
    </reference>
    <reference>
      <citation>Beste C, Wascher E, Dinse HR, Saft C. Faster perceptual learning through excitotoxic neurodegeneration. Curr Biol. 2012 Oct 23;22(20):1914-7. doi: 10.1016/j.cub.2012.08.012. Epub 2012 Sep 13.</citation>
      <PMID>22981772</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>32161030</PMID>
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    <reference>
      <citation>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.</citation>
      <PMID>5666169</PMID>
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    <reference>
      <citation>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.</citation>
      <PMID>28284903</PMID>
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    <reference>
      <citation>Fahle M. Perceptual learning: a case for early selection. J Vis. 2004 Oct 26;4(10):879-90. doi: 10.1167/4.10.4.</citation>
      <PMID>15595892</PMID>
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    <reference>
      <citation>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.</citation>
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    <reference>
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      <citation>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.</citation>
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    <reference>
      <citation>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.</citation>
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    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Valencia</investigator_affiliation>
      <investigator_full_name>Amparo Diez</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Parkinson's Disease</keyword>
    <keyword>Vision</keyword>
    <keyword>Ocular Motility Disorders</keyword>
    <keyword>Perceptual Disorders</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Parkinson Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06032130
  org study id: 2161984
  nct id: NCT06032130
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  Parkinson's disease (PD) is the second most common neurodegenerative condition worldwide. It
        is a movement disorder characterised by tremor, rigidity, bradykinesia and postural
        instability. However, 78% of PD patients report visual problems such as dry eye, reduced
        visual acuity, visual field defects, impaired contrast sensitivity (CS), impaired eye
        movements, diplopia, convergence insufficiency, impaired colour vision, visual hallucinations
        and problems in visual-spatial orientation. In fact, visual dysfunction is one of the initial
        symptoms of PD. A recent study has found that dopaminergic neurons affected in PD show
        physiological dysfunctions, but do not die. Currently, there is no cure for PD; treatments
        consist of controlling symptoms, and the earlier the disease is detected and administered,
        the more effective they are.
  
        It is hypothesised that a programme of visual oculomotor therapy and/or visual perceptual
        learning (VPL) could slow or halt the deterioration of oculomotor ability and/or CS in these
        patients. Visual perceptual learning or VPL is a long-term improvement in performance on a
        visual task, any relatively permanent change in perception that arises from visual
        experience. Contrast Sensitivity or CS is the ability of the visual system to differentiate
        an object from the background in which it is located by the difference in contrast. It is the
        ability to detect differences in luminance between adjacent areas in an image.
  
        If the results confirm the hypothesis, this study will have a great impact on the PD
        population because it could slow down the deterioration of oculomotor ability that 75% of
        them suffer from. It could also slow down the decline in CS that they suffer, as demonstrated
        by several studies. Consequently, patients would also experience an improvement in their
        quality of life, as they would be able to continue to perform activities of daily living that
        are affected by visual impairment such as walking, reading, driving and cooking. This would
        have a major impact on society as PD affects many people worldwide. In Europe, the prevalence
        and incidence rates of PD are estimated to be approximately 108-257/100 000 and 11-19/100 000
        per year, respectively. Furthermore, this project would expand scientific knowledge because
        to date there is no literature that has evaluated VPL in patients with PD. However, there is
        research on amblyopia, Stargardt's disease and other neural pathologies, such as Huntington's
        disease. Likewise, with regard to oculomotor therapy, there is still a lot of research to be
        done, as there are few studies on this subject.
  
        This is an analytical, longitudinal, prospective and observational study. In the first phase,
        to characterise the vision of the population with Parkinson's disease, non-invasive tests
        would be performed, such as measuring visual acuity, refraction, contrast sensitivity, colour
        vision, depth vision, the state of binocular vision and visual pathways and eye movements.
        Simultaneously, a control population will be measured to compare the data obtained in PD
        patients.
  
        In a second phase, visual oculomotor and/or perceptual exercises would be performed in a
        group of PD patients to assess whether there is stabilisation of the impairment and/or
        improvement of these visual skills.
  
        Finally, in the third phase, those visual skills that have been treated would be re-evaluated
        to assess possible changes, compared with a group of PD patients who have not undergone the
        visual exercises.
  
        The research will be carried out at the Laboratory of Vision and Colour Sciences of the
        Department of Optics, Optometry and Vision Sciences of the University of Valencia, at the
        Arnau de Vilanova Hospital and at the Parkinson's Association of Valencia. These are the
        institutions from which the participants who take part in the study will come. They will do
        so voluntarily, will not be coerced to participate in any way and will be free to choose
        whether they want to participate or not, after having been explained to them what this
        project consists of. Furthermore, they will be able to revoke their signed consent at any
        time, so that they will automatically be excluded from the study and their data will not be
        used in the study if the patient so wishes. Furthermore, this project does not harm the
        patient's health and does not bring any financial benefit to the patient.
  
        Only the members of the project will have access to the original study data. These data will
        be collected on paper, and the original source will be kept under lock and key in the
        laboratory of Vision and Colour Sciences of the Department of Optics, Optometry and Vision
        Sciences of the University of Valencia. For data analysis, the principal investigator will
        extract the data into a computer document in which each patient will be identified by a
        two-letter code (GP: control group; PD: Parkinson's patient) and three numbers. Not even the
        initials of the name will appear. Under this code, the data of each patient will be entered.
        This is the data that the rest of the group will see and have access to. Adverse event
        reporting and change management will be carried out through the Reservio platform, which will
        be used for appointment planning and online booking.
  
        Data analysis will be carried out using the SPSS (Statistical Package for Social Sciences)
        statistical software and the Matlab numerical calculation system. The statistical analysis
        plan is as follows: the mean, standard deviation and normality of the samples will be
        performed with the Shapiro-Wilk test. Statistical comparison between groups will be performed
        with Student's t-test if the data follow a normal distribution or with the U-Mann-Whitney
        test otherwise. The statistical test used for qualitative variables will be Pearson's
        chi-square test.
  observational model: Case-Control
  time perspective: Prospective
  measure: Anamnesis
  time frame: 1 year
  description: 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.
  measure: Visual Acuity
  time frame: 1 year
  description: Using an EDTRS (Early Treatment Diabetic Retinopathy Study) test for distance and near vision with the patient's optical correction, scale: LogMAR.
  measure: Refraction
  time frame: 1 year
  description: Doing ocular compensation with trial frame refraction, units: diopters (D).
  measure: Pupillary diameter
  time frame: 1 year
  description: Under photopic and mesopic illumination conditions using a specific millimetric ruler, units: millimeters (mm).
  measure: Ocular sensory dominance
  time frame: 1 year
  description: Using the red filter test.
  measure: Binocular vision status
  time frame: 1 year
  description: Using the Cover Test Cover Test, Modified Thorington Test Card to phoria measurement and fusional vergence measurement with prism bar, units: prismatic diopters (Δ).
  measure: Achromatic CSF (Contrast Sensitivity Funtion)
  time frame: 1 year
  description: 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.
  measure: Stereopsis
  time frame: 1 year
  description: Using the Wirth points of the Titmus test, units: seconds of arc (").
  measure: Colour vision
  time frame: 1 year
  description: Using the Farnsworth-Munsell 100 Hue sorting test and the Chromatic Threshold Measurement test.
  measure: Eye movements quality
  time frame: 1 year
  description: Using aDEMd (adult Developmental Eye Movement with distractors) test and NSUCO (Northeastern State University College of Optometry) test. Units: seconds (s).
  measure: Reading speed
  time frame: 1 year
  description: Using Radner-Vissum test, units: seconds (s).
  measure: Life quality assessment
  time frame: 1 year
  description: Scoring the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25). Higher scores mean a better outcome. Minimum value: 0, maximum value: 100.
  measure: Pursuit eye movements
  time frame: 1 year
  description: Would be performed noninvasively using simple, easy-to-use instruments such as flashlights, pointers, slates, Marsden's ball, rotating devices and Groffman's visual tracing test. If financial resources permit, an application on an electronic device could also be used.
  From these exercises, the following variables will be collected: time spent in the performance of the exercises in seconds (s) and errors made. These will be compared before and after the therapy.
  In addition, the patients would be given indications for the work of these exercises at home.
  measure: Saccadic eye movements
  time frame: 1 year
  description: Would be performed noninvasively using simple, easy-to-use instruments such as flashlights, pointers, slates, Hart's charts, ARB charts and Ann Arbor tracing sheets. If financial resources permit, an application on an electronic device could also be used.
  From these exercises, the following variables will be collected: time spent in the performance of the exercises in seconds (s) and errors made. These will be compared before and after the therapy.
  In addition, the patients would be given indications for the work of these exercises at home.
  measure: Perceptual learning technique
  time frame: 1 year
  description: Perceptual learning exercises could also be performed on an electronic device with a program that displays Gabor patches. This technique consists of a task with low-contrast, progressively decreasing, sustained attention, demanding and repetitive stimuli.
  arm group label: Parkinson Disease Group (PD)
  description: Anamnesis
  Measurement of best visual acuity with an EDTRS (Early Treatment Diabetic Retinopathy Study) test
  Measurement of refraction with trial frame refraction
  Measurement of pupillary diameter under photopic and mesopic illumination conditions using a specific millimetric ruler
  Measurement of ocular sensory dominance with the red filter test
  Measurement of binocular vision status with the Cover Test, prism bar and Maddox wing
  Photopic and mesopic achromatic contrast sensitivity using the Functional Test Analyzer device
  Stereopsis using the Titmus Test
  Colour vision using the Farnsworth-Munsell 100 Hue sorting test
  Measurement of eye movements with aDEMd (adult Developmental Eye Movement) test and NSUCO (Northeastern State University College of Optometry)
  Measurement of reading speed with Radner-Vissum test
  National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25)
  arm group label: Control Group (GP)
  description: 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
  Measurement of best visual acuity with an EDTRS test
  Measurement of refraction with trial frame refraction
  Measurement of pupillary diameter under photopic and mesopic illumination conditions using a specific millimetric ruler
  Measurement of ocular sensory dominance with the red filter test
  Measurement of binocular vision status with the Cover Test, prism bar and Maddox wing
  Photopic and mesopic achromatic contrast sensitivity using the Functional Test Analyzer device
  Stereopsis using the Titmus Test
  Colour vision using the Farnsworth-Munsell 100 Hue sorting test
  Measurement of eye movements with aDEMd test and NSUCO
  Measurement of reading speed with Radner-Vissum test
  NEI VFQ-25
  arm group label: Therapy Parkinson Disease Group (TPD)
  description: 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.
  arm group label: Control Parkinson Disease Group (CPD)
  description: 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.
  intervention type: Other
  intervention name: Clinical measurements
  description: Optometric measurements
  arm group label: Control Group (GP)
  arm group label: Control Parkinson Disease Group (CPD)
  arm group label: Parkinson Disease Group (PD)
  intervention type: Other
  intervention name: Oculomotor or perceptual therapy
  description: Oculomotor or perceptual visual learning exercices
  arm group label: Therapy Parkinson Disease Group (TPD)
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: 100 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: María Amparo Díez-Ajenjo, PhD
  role: Principal Investigator
  affiliation: University of Valencia
  last name: María Amparo Díez-Ajenjo, PhD
  phone: (+34) 963 86 41 00
  phone ext: 44170
  email: amparo.diez@uv.es
  last name: Rosa María Hernández-Andrés, PhD
  phone: (+34) 963 86 41 00
  phone ext: 44098
  email: rosa.m.hernandez@uv.es
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  PMID: 32044947
  citation: Armstrong RA. Visual symptoms in Parkinson's disease. Parkinsons Dis. 2011;2011:908306. doi: 10.4061/2011/908306. Epub 2011 May 25.
  PMID: 21687773
  citation: Balestrino R, Schapira AHV. Parkinson disease. Eur J Neurol. 2020 Jan;27(1):27-42. doi: 10.1111/ene.14108. Epub 2019 Nov 27.
  PMID: 31631455
  citation: Beste C, Wascher E, Dinse HR, Saft C. Faster perceptual learning through excitotoxic neurodegeneration. Curr Biol. 2012 Oct 23;22(20):1914-7. doi: 10.1016/j.cub.2012.08.012. Epub 2012 Sep 13.
  PMID: 22981772
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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.
  PMID: 34732887
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
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  PMID: 32741840
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  PMID: 454234
  responsible party type: Principal Investigator
  investigator affiliation: University of Valencia
  investigator full name: Amparo Diez
  investigator title: Principal Investigator
  mesh term: Parkinson Disease
  sharing ipd: No