| CTRI Number |
CTRI/2023/08/056262 [Registered on: 08/08/2023] Trial Registered Prospectively |
| Last Modified On: |
19/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of Functional Vision in Parkinsons Disease |
|
Scientific Title of Study
|
Functional vision assessment in Individuals with Parkinsons disease-A Hospital-Based study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sushma |
| Designation |
Post Graduate Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Optometry, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8105660202 |
| Fax |
|
| Email |
sushma.mchpmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Judy Jose |
| Designation |
Assistant Professor-Senior scale |
| Affiliation |
Manipal College of HealthProfessions |
| Address |
Department of Optometry, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9061699857 |
| Fax |
|
| Email |
judy.jose@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sushma |
| Designation |
Post Graduate Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Optometry, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8105660202 |
| Fax |
|
| Email |
sushma.mchpmpl2022@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal-576104, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Sushma |
| Address |
Department of Optometry, Manipal College of Health professions, Manipal Academy of Higher Education, Manipal 576104, Karnataka, India |
| Type of Sponsor |
Other [Self sponsor] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sushma |
Kasturba Hospital |
Department of Neurology, 1st floor, Room number 11
Udupi
KARNATAKA |
8105660202
sushma.mchpmpl2022@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 (student research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G20||Parkinsons disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Individuals diagnosed with Parkinson’s
disease will be included |
|
| ExclusionCriteria |
| Details |
Individuals with a
history of traumatic brain injury, Individuals with ocular/ systemic disease on any medications which are
known to affect the visual function, Individuals with one eye, Those with amblyopia or tropia, Diagnosed
with dementia (as documented in the report) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual acuity (log unit), Ocular motility
(Normal/abnormal), Pupillary reaction (RAPD +ve/-ve), Depth perception (seconds of arc), Color
perception (Normal/abnormal), Contrast sensitivity (log unit), Visual field (Normal/abnormal) |
Baseline data and functional vision assessment (on the same day) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/08/2023 |
| Date of Study Completion (India) |
16/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will begin after obtaining IRC and IEC
approvals and Registration in Clinical Trial Registry- India. Informed consent will be obtained from the
participants before proceeding with the study. Participants will be recruited based on inclusion and
exclusion criteria. Individuals between 30-70 years of age with Parkinson’s disease will be recruited for
the study. After taking a detailed history of participants and assessing baseline examination including
hand-held slit lamp and fundus evaluation for inclusion criteria, functional vision will be assessed with
non-contact methods including a visual acuity test using log MAR chart (distance, near), Pelli-Robson
contrast sensitivity, color vision, stereopsis, Amsler grid, and confrontation test for the visual field, ocular
motility, pupillary examination. Best corrected visual acuity for distance will be assessed using Log MAR
visual acuity chart and N-notation for near visual acuity, where participants are asked to identify the
letters at a specific testing distance. The pupillary examination will be performed using a pen torch with
dim room illumination. An ocular motility test will be performed by showing the target to the participant
at one arm’s distance and asking them to follow the target without rotating their head to assess the
movements and alignment of eyes. The stereopsis test will be assessed using the Random stereo test
and participants are asked to identify the shapes during testing. Then, Colour vision perception will be
assessed using HRR (Hardy-Rand-Rittler) pseudo isochromatic color vision plates where a participant’s
one eye will be occluded to assess monocularly. Contrast sensitivity will be measured using a Pelli-Robson contrast sensitivity chart at 100cm (both monocular and binocular) and the Visual field will be
tested monocularly using an Amsler grid at the participant’s comfortable reading distance to assess the
central field of vision and for overall field of vision, confrontation test will be assessed one eye at a time
at one arm distance. The entire process might take half an hour. This study does not involve any invasive
procedure and any second visit assessments. No additional costs for participating in the study. All tests
done are part of the standard of care. After collecting the required data, the results will be noted and
analyzed to quantify the changes in functional vision parameters. |