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临床试验/NCT06032130
NCT06032130已完成不适用

"Characterization of Visual Problems in Patients With Parkinson's Disease and Application of an Oculomotor and/or Perceptual Therapy Program"

University of Valencia2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2023年11月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
2
主要终点
Achromatic CSF (Contrast Sensitivity Funtion)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
30 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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)

干预措施: Clinical measurements (Other)

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

干预措施: Clinical measurements (Other)

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.

干预措施: Oculomotor or perceptual therapy (Other)

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.

干预措施: Clinical measurements (Other)

结局指标

主要结局

Achromatic CSF (Contrast Sensitivity Funtion)

时间窗: 1 year

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.

Anamnesis

时间窗: 1 year

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.

Visual Acuity

时间窗: 1 year

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

Life quality assessment

时间窗: 1 year

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

Refraction

时间窗: 1 year

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

Pupillary diameter

时间窗: 1 year

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

Binocular vision status

时间窗: 1 year

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

Stereopsis

时间窗: 1 year

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

Reading speed

时间窗: 1 year

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

Colour vision

时间窗: 1 year

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

Eye movements quality

时间窗: 1 year

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

Ocular sensory dominance

时间窗: 1 year

Using the red filter test.

次要结局

  • Saccadic eye movements(1 year)
  • Pursuit eye movements(1 year)
  • Perceptual learning technique(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amparo Diez

Principal Investigator

University of Valencia

研究点 (2)

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