Study Regarding the Realization of a Standardized Protocol for the Evaluation of the Visual Condition in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Inspection of orthoptic condition in patients with PD
研究概览
简要总结
Non motor symptoms and signs in Parkinson's disease (PD) also include a series of visual deficits; deepening these aspects could be useful for a better management of symptoms, to standardize a specific protocol for the issues related to vision and also to understand how these aspects are important for the understanding of the mechanisms underlying the PD.
详细描述
In Parkinson's disease (PD) several non-motor signs and symptoms already occur in the early stages of the disease; the symptoms are diverse and these also involve visual difficulties which commonly affect the majority of patients and which gradually worsen the quality of life.
The most common malfunction produced by PD is the dysfunction of dopaminergic pathways that may be responsible for a series of visual deficits too:
- decreased visual acuity and decreased sensibility to light and color,
- strabismus and forms of sensory and eye movement dysfunctions,
- eyelid dysfunctions and dry eye syndrome
Moreover, in patients affected by PD, typical retinal features were discovered for the first time in 2004 by the use of OCT (Optical Coherence Tomography) such as:
- the reduction of the retinal nerve fiber layer (RNFL)
- a typical thinning of the macular thickness, even if with different results. In the follow-up of the PD, these retinal features, verifiable by the use of OCT, could be considered as a marker of the pathology.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged ≥ 18 years
- •Patients affected by Parkinson's disease (PD) according to the diagnostic criteria of the United Kingdom Brain Bank, in the ON phase of their usual treatment
- •Hoehn-Yahr Stage from 1 to 3
- •Signature of the Informed Consent and of the privacy form
排除标准
- •Patients with symptoms and signs compatible with atypical parkinsonism
- •PD patients treated with antagonist drugs for central dopaminergic receptors (first and second generation antipsychotics) in the last 6 months before enrollment
- •Patients suffering from other neurological diseases
- •Patients with evident cognitive impairment (MMSE <24/30)
- •Patients with manifest eye movement disorders prior to the diagnosis of PD.
- •Patients with daltonism
- •Patients with amblyopia
- •Patients suffering from high anisometropia
- •Patients suffering from advanced cataracts
- •Patients suffering from glaucoma
- •Patients suffering from maculopathy
- •Patients suffering from pathologies of the optic nerve
- •Patients with severe visual field deficits
- •Patients with refractive defects above 5 diopters
结局指标
主要结局
Inspection of orthoptic condition in patients with PD
时间窗: through study completion with an avarage of 6 months
Analysis of orthoptic features in patients with PD trough the quantification of the fusional amplitude expressed in prismatic diopters at distance (6 meters) and near (40 cm).
Observation of retinal features in patients with PD through the use of OCT
时间窗: through study completion with an avarage of 6 months
Registration of the retinal features in patients with PD using OCT trough a quantitative analysis of the macular area and of the optical disc by the registration of retinal tickness expressed in microns for RPE, RNFL and Neuroretine Layer.
Survey the validity of a specific diagnostic protocol for the evaluation of the visual condition in patients with PD.
时间窗: through study completion with an avarage of 6 months
Review the validity of a specific and integrated ambulatory diagnostic protocol for the study of visual and ophthalmological disorders through a visit protocol and exams designed specifically for patients with PD based on the evidence of visual conditions in the disease currently present in the scientific literature trough the measurement of ocular pressure expressed in mmHg by the use of a Non- Contact Tonometry.
Check the impact of visual condition on the quality of life in patients with PD through the use of questionnaires.
时间窗: through study completion with an avarage of 6 months
Quantify the impact of visual condition using the VFQ-25 (Visual Functional Questionnaire) in patients with PD through the main method of this questionnaire: all items are scored, each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively so that scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score. The lowest percentage is the better outcome for the visual condition.
次要结局
未报告次要终点
研究者
Nicola Modugno
Neurologist, Head of Parkinson Center
Neuromed IRCCS