| CTRI Number |
CTRI/2021/07/034798 [Registered on: 13/07/2021] Trial Registered Prospectively |
| Last Modified On: |
04/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Vision therapy] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of eye exercises on treating eye movement problems in individuals with Parkinson’s disease |
|
Scientific Title of Study
|
Effect of vision therapy on oculomotor function and vision related quality of life in individuals with Parkinson’s disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Judy Jose |
| Designation |
Assistant professor-Senior scale |
| Affiliation |
MAHE |
| Address |
Department of Optometry,
Manipal College of Health Professions,
MAHE, Manipal
KMC quarters 139,
MAnipal campus,
MAHE,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09061699857 |
| Fax |
|
| Email |
judy.jose@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bincy M George |
| Designation |
Associate professor |
| Affiliation |
MAHE |
| Address |
Department of Anatomy,
MMMC, Manipal
MAHE, Manipal
KMC quarters 139,
MAnipal campus,
MAHE,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9986104682 |
| Fax |
|
| Email |
bincy.george@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Judy Jose |
| Designation |
Assistant professor-Senior scale |
| Affiliation |
MAHE |
| Address |
Department of Optometry,
Manipal College of Health Professions,
MAHE, Manipal
KMC quarters 139,
MAnipal campus,
MAHE,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09061699857 |
| Fax |
|
| Email |
judy.jose@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal |
|
|
Primary Sponsor
|
| Name |
Judy Jose |
| Address |
Department of Optometry,
MCHP,
Manipal, Karnataka |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Judy Jose |
Neurology OPD |
Neurology department, 1st floor, KMC, MAnipal
Udupi
KARNATAKA |
09061699857
judy.jose@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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H518||Other specified disorders of binocular movement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Vision therapy |
Eye Exercises are to be done 5 days/week, 3 times/day
Saccade and pursuit exercises : 3 min each time
Exercise for CI will be for 5 minutes each time (i.e., 2 min: pencil pushups; 3 min: Brock string).
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with Idiopathic Parkinson’s disease under regular medication who are having oculomotor dysfunction
Individuals whose best-corrected distance visual acuity not less than 6/18 and near acuity not less than N24 |
|
| ExclusionCriteria |
| Details |
Subjects being one-eyed
Subjects who are not able to comprehend and respond to the instruction given due to reduced visual acuity or hearing impairment
Subjects with severe cognitive problems/ dementia
Subjects who are already on any kind of eye exercises |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
ï‚· CISS score
ï‚· VFQ-25 score
ï‚· Fixation stability
ï‚· Reaction time, Peak velocity, Acceleration and gain of saccade
ï‚· Pursuit gain
ï‚· Phoria measured in degrees
ï‚· NPC in millimetres
ï‚· PFV in prism dioptres |
1st week and 12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. CISS score
2. VFQ-25 score
3. Fixation stability
4. Reaction time, Peak velocity, Acceleration and gain of saccade
5. Pursuit gain
6. Phoria measured in degrees
7. NPC in millimeters
8. PFV in prism diopters |
After 3 months of vision therapy |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
01/12/2021 |
| 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="4"
Months="1"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This research aims to study the effect of vision therapy on oculomotor functions and vision-related quality of life in individuals with Parkinson’s disease. The main objectives of this study include (1) To estimate the oculomotor functions associated with Parkinson’s disease, (2) To find the effectiveness of vision therapy on oculomotor functions in individuals with Parkinson’s disease, (3) To assess vision related quality of life in individuals with Parkinson’s disease before and after vision therapy. This study hypothesizes that there will be an improvement in oculomotor functions in individuals with Parkinson’s disease after a period of vision therapy and thereby an improvement in their vision-related quality of life. |