Parkinson DiseaseNCT03743467
Study on the Visual Condition in Parkinson's Disease
An observational study of Parkinson Disease, run by Neuromed IRCCS at 2 sites in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Clinical evaluation of vision and eye tests
- How many people
- 90 participants
- Where
- 2 sitesItaly
- Study dates
- 5 Nov 2018to 26 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. 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) coming from Parkinson's Center of Neuromed IRCCS Institute with signature of the Informed Consent and of the privacy form. 2. Health subjects coming from Neurological Department of Neuromed IRCCS Institute with signature of the Informed Consent and of the privacy form.
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Neuromed IRCCS
Pozzilli, Isernia, 86077
Modugno Nicola, MD, PhD, 00390865929250, nicusmod@gmail.com
Michele Meglio, BSc, M.Sc, 00393332069181, michele.meglio@neuromed.it
- Recruiting
Irccs Neuromed
Pozzilli, Isernia, 86170
Nicola Modugno, MD, PhD, +393922571585, nicusmod@gmail.com
Michele Meglio, BSc,M.sc, 00393332069181, michele.meglio@neuromed.it
About this study
Official title: Study Regarding the Realization of a Standardized Protocol for the Evaluation of the Visual Condition in Parkinson's Disease
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.
Read the detailed description
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.
For these reasons it may be useful:
- quantify in an objective manner how much the visual aspects affect the overall deterioration of the quality of life in patients with PD
- demonstrate the validity of a specific and integrated outpatient diagnostic protocol for the study of visual and ophthalmological disorders in patients with PD
- demonstrate the diagnostic role of early changes in macular thickness and of the optic disc in subjects suffering from PD using the OCT
- establish orthoptic evidence in patients with PD
- Conditions
- Parkinson Disease
- Being tested
- Clinical evaluation of vision and eye tests
- Keywords
- Parkinson's disease, vision, quality of life
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical evaluation of vision and eye testsDiagnostic test
- VFQ-25 Questionnaire
- BCVA
- Contrast sensitivity
- Color sensitivity examination (Ishihara test 38 plates)
- Complete evaluation of orthoptic features, eye movements, eyelid function, pupil function
- Slit lamp examination
- Shirmer test, Break up time test
- Corneal pachymetry (optical pachymetry)
- IOP
- Quantitative and qualitative analysis of the macular area and of the optical disc by OCT: RPE, RNFL and Neuroretine Layer
| Study group | Role | What they receive |
|---|---|---|
| Control group | Health subjects Receives: Diagnostic Test: Clinical evaluation of vision and eye tests | |
| PD patients Hoehn Yahr 1 | Patients with Hoehn Yahr stage 1 Receives: Diagnostic Test: Clinical evaluation of vision and eye tests | |
| PD patients Hoehn Yahr 2-3 | Patients with Hoehn Yahr stage 2 and 3 Receives: Diagnostic Test: Clinical evaluation of vision and eye tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Check the impact of visual condition on the quality of life in patients with PD through the use of questionnaires.
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.
Measured: through study completion with an avarage of 6 months
Survey the validity of a specific diagnostic protocol for the evaluation of the visual condition in patients with PD.
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 best corrected visual acuity expressed in twentieths and the use of the SLOAN chart.
Measured: through study completion with an avarage of 6 months
Survey the validity of a specific diagnostic protocol for the evaluation of the visual condition in patients with PD.
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 quantification of contrast sensitivity expressed by the CSC (contrast sensitivity curve) trough the use of the Contrast Sensitivity Chart 6 lines.
Measured: through study completion with an avarage of 6 months
Survey the validity of a specific diagnostic protocol for the evaluation of the visual condition in patients with PD.
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 color sensitivity examination with the administration of the Ishihara test (38 plates) and results expressed by the Ishihara algorithm.
Measured: through study completion with an avarage of 6 months
Survey the validity of a specific diagnostic protocol for the evaluation of the visual condition in patients with PD.
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 Shirmer test with results expressed in millimeters.
Measured: through study completion with an avarage of 6 months
Survey the validity of a specific diagnostic protocol for the evaluation of the visual condition in patients with PD.
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 break up time test with results expressed in seconds of tear break.
Measured: through study completion with an avarage of 6 months
Survey the validity of a specific diagnostic protocol for the evaluation of the visual condition in patients with PD.
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.
Measured: through study completion with an avarage of 6 months
Inspection of orthoptic condition in patients with PD
Analysis of orthoptic features in patients with PD trough eye movements examination to determine hypofunctions/ hyperfunctions in ductions and versions.
Measured: through study completion with an avarage of 6 months
Inspection of orthoptic condition in patients with PD
Analysis of orthoptic features in patients with PD trough the quantification of convergence by the calculation of the near point of convergence expressed in millimeters.
Measured: through study completion with an avarage of 6 months
Inspection of orthoptic condition in patients with PD
Analysis of orthoptic features in patients with PD trough the quantification of stereopsis expressed in seconds of arc trough the use of Lang stereo test and TNO stereo test.
Measured: through study completion with an avarage of 6 months
Inspection of orthoptic condition in patients with PD
Analysis of orthoptic features in patients with PD by checking the presence of latent or manifest squint trough Cover and Uncover test in 9 position of gaze.
Measured: through study completion with an avarage of 6 months
Inspection of orthoptic condition in patients with PD
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).
Measured: through study completion with an avarage of 6 months
Observation of retinal features in patients with PD through the use of OCT
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.
Measured: through study completion with an avarage of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start5 Nov 2018 (estimated)
- Primary completion5 Nov 2018 (estimated)
- Study completion26 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuromed IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Modugno, Neuromed IRCCS
- Investigators
- Modugno Nicola, MD, PHD, Principal investigator, Neuromed IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743467
- Sponsor's protocol ID
- NMOD_01
- Status last verified
- Nov 2018
- First submitted
- 7 Nov 2018
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Regarding the Realization of a Standardized Protocol for the Evaluation of the Visual Condition in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03743467
- Acronym / sponsor ID
- NMOD_01
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, vision, quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Neuromed IRCCSUniversity, hospital or other
- Study start
- 5 Nov 2018 (estimated)
- Primary completion
- 5 Nov 2018 (estimated)
- Study completion
- 26 May 2019 (estimated)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
For these reasons it may be useful:
- quantify in an objective manner how much the visual aspects affect the overall deterioration of the quality of life in patients with PD
- demonstrate the validity of a specific and integrated outpatient diagnostic protocol for the study of visual and ophthalmological disorders in patients with PD
- demonstrate the diagnostic role of early changes in macular thickness and of the optic disc in subjects suffering from PD using the OCT
- establish orthoptic evidence in patients with PD
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Diagnostic Test: Clinical evaluation of vision and eye testsHealth subjects |
| PD patients Hoehn Yahr 1 | – | Diagnostic Test: Clinical evaluation of vision and eye testsPatients with Hoehn Yahr stage 1 |
| PD patients Hoehn Yahr 2-3 | – | Diagnostic Test: Clinical evaluation of vision and eye testsPatients with Hoehn Yahr stage 2 and 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. 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) coming from Parkinson's Center of Neuromed IRCCS Institute with signature of the Informed Consent and of the privacy form. 2. Health subjects coming from Neurological Department of Neuromed IRCCS Institute with signature of the Informed Consent and of the privacy form.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical evaluation of vision and eye tests* VFQ-25 Questionnaire * BCVA * Contrast sensitivity * Color sensitivity examination (Ishihara test 38 plates) * Complete evaluation of orthoptic features, eye movements, eyelid function, pupil function * Slit lamp examination * Shirmer test, Break up time test * Corneal pachymetry (optical pachymetry) * IOP * Quantitative and qualitative analysis of the macular area and of the optical disc by OCT: RPE, RNFL and Neuroretine Layer | Diagnostic test | Control group, PD patients Hoehn Yahr 1, PD patients Hoehn Yahr 2-3 |
Primary outcome
Check the impact of visual condition on the quality of life in patients with PD through the use of questionnaires.
Time frame: 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.
Survey the validity of a specific diagnostic protocol for the evaluation of the visual condition in patients with PD.
Time frame: 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 best corrected visual acuity expressed in twentieths and the use of the SLOAN chart.
Survey the validity of a specific diagnostic protocol for the evaluation of the visual condition in patients with PD.
Time frame: 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 quantification of contrast sensitivity expressed by the CSC (contrast sensitivity curve) trough the use of the Contrast Sensitivity Chart 6 lines.
Survey the validity of a specific diagnostic protocol for the evaluation of the visual condition in patients with PD.
Time frame: 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 color sensitivity examination with the administration of the Ishihara test (38 plates) and results expressed by the Ishihara algorithm.
Survey the validity of a specific diagnostic protocol for the evaluation of the visual condition in patients with PD.
Time frame: 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 Shirmer test with results expressed in millimeters.
Survey the validity of a specific diagnostic protocol for the evaluation of the visual condition in patients with PD.
Time frame: 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 break up time test with results expressed in seconds of tear break.
Survey the validity of a specific diagnostic protocol for the evaluation of the visual condition in patients with PD.
Time frame: 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.
Inspection of orthoptic condition in patients with PD
Time frame: through study completion with an avarage of 6 months
Analysis of orthoptic features in patients with PD trough eye movements examination to determine hypofunctions/ hyperfunctions in ductions and versions.
Inspection of orthoptic condition in patients with PD
Time frame: through study completion with an avarage of 6 months
Analysis of orthoptic features in patients with PD trough the quantification of convergence by the calculation of the near point of convergence expressed in millimeters.
Inspection of orthoptic condition in patients with PD
Time frame: through study completion with an avarage of 6 months
Analysis of orthoptic features in patients with PD trough the quantification of stereopsis expressed in seconds of arc trough the use of Lang stereo test and TNO stereo test.
Inspection of orthoptic condition in patients with PD
Time frame: through study completion with an avarage of 6 months
Analysis of orthoptic features in patients with PD by checking the presence of latent or manifest squint trough Cover and Uncover test in 9 position of gaze.
Inspection of orthoptic condition in patients with PD
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Modugno Nicola, MD, PHD principal investigator
Neuromed IRCCS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Neuromed IRCCS at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicola Modugno, MD, PhD (00390865929250, nicusmod@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Check the impact of visual condition on the quality of life in patients with PD through the use of questionnaires. (time frame: through study completion with an avarage of 6 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2018.