| CTRI Number |
CTRI/2025/08/092668 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
29/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study on Vision Problems in People with Parkinson’s Disease and Their Impact on Daily Activities |
|
Scientific Title of Study
|
Visual Field Defects in Parkinson’s Disease: A Cross-Sectional Study on Their Clinical Patterns and Impact on Vision-Related Activities of Daily Living |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priti Singh |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhopal |
| Address |
Dept of Ophthalmology AIIMS Campus Rd, AIIMS Campus, Saket Nagar, Habib Ganj, Bhopal, Madhya Pradesh
Dept of Ophthalmology AIIMS Campus Rd, AIIMS Campus, Saket Nagar, Habib Ganj, Bhopal, Madhya Pradesh
Bhopal
MADHYA PRADESH
462026
India |
| Phone |
9993896479 |
| Fax |
|
| Email |
priti.ophtho@aiimsbhopal.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priti Singh |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhopal |
| Address |
Dept of Ophthalmology AIIMS Campus Rd, AIIMS Campus, Saket Nagar, Habib Ganj, Bhopal, Madhya Pradesh
Dept of Ophthalmology AIIMS Campus Rd, AIIMS Campus, Saket Nagar, Habib Ganj, Bhopal, Madhya Pradesh
Bhopal
MADHYA PRADESH
462026
India |
| Phone |
9993896479 |
| Fax |
|
| Email |
priti.ophtho@aiimsbhopal.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priti Singh |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhopal |
| Address |
Dept of Ophthalmology AIIMS Campus Rd, AIIMS Campus, Saket Nagar, Habib Ganj, Bhopal, Madhya Pradesh
Dept of Ophthalmology AIIMS Campus Rd, AIIMS Campus, Saket Nagar, Habib Ganj, Bhopal, Madhya Pradesh
Bhopal
MADHYA PRADESH
462026
India |
| Phone |
9993896479 |
| Fax |
|
| Email |
priti.ophtho@aiimsbhopal.edu.in |
|
|
Source of Monetary or Material Support
|
| Dept of Ophthalmology AIIMS Campus Rd, AIIMS Campus, Saket Nagar, Habib Ganj, Bhopal, Madhya Pradesh 462026 |
|
|
Primary Sponsor
|
| Name |
Dr Priti Singh |
| Address |
AIIMS Campus, Saket Nagar, Habib Ganj, Bhopal, Madhya Pradesh 462026 |
| Type of Sponsor |
Other [Self Funded ] |
|
|
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 Priti Singh |
AIIMS Bhopal |
Department of Ophthalmology AIIMS Campus Rd, AIIMS Campus, Saket Nagar, Habib Ganj, Bhopal, Madhya Pradesh
Bhopal
MADHYA PRADESH |
9993896479
priti.ophtho@aiimsbhopal.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of medical science Bhopal Institutional human ethics committee |
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 |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
Diagnosed Parkinson’s Disease (Hoehn and Yahr Stage I–IV)
Age above 40 years (to exclude young-onset Parkinson’s Disease)
Ability to complete visual field testing and related questionnaires |
|
| ExclusionCriteria |
| Details |
Severe cognitive impairment (as per MMSE assessment)
Advanced dementia or psychiatric illness interfering with participation
Ocular conditions independently causing visual field loss (e.g., advanced glaucoma, retinal dystrophies)
Recent ocular surgery within the past 3 months
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation between visual field defects and disease severity, cognitive function (MoCA), and vision-related quality of life (NEI VFQ-25) |
At baseline and at 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Identification of visual field defect subtypes using cluster analysis of perimetry data |
At the end of data collection phase (Month 6–9) |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [priti.ophtho@aiimsbhopal.edu.in].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This cross-sectional observational study aims to evaluate the prevalence and clinical patterns of visual field defects in individuals diagnosed with Parkinson’s Disease. Visual impairments are increasingly recognized as significant non-motor symptoms of Parkinson’s Disease but are often underdiagnosed in routine clinical practice. The study will use standard visual field testing and cognitive assessments to explore the association between visual deficits, disease severity, and impact on vision-dependent activities of daily living. The hypothesis is that visual field defects are prevalent in Parkinson’s Disease and correlate with disease severity and functional impairment. |