| CTRI Number |
CTRI/2024/11/076868 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of ocular movements among the patients with Alzheimers disease |
|
Scientific Title of Study
|
Saccadic eye movements in Alzheimers disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Namratha Hegde |
| Designation |
Associate Professor |
| Affiliation |
Sankara College of Optometry |
| Address |
Department of Optometry, Sankara College of Optometry, Sankara Eye Hospital, Varthur Main Road, Kundalahalli Gate, Bangalore
Bangalore
KARNATAKA
560037
India |
| Phone |
9986266576 |
| Fax |
|
| Email |
namratha.hegde@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Namratha Hegde |
| Designation |
Associate Professor |
| Affiliation |
Sankara College of Optometry |
| Address |
Department of Optometry, Sankara College of Optometry, Sankara Eye Hospital, Varthur Main Road, Kundalahalli Gate, Bangalore
Bangalore
KARNATAKA
560037
India |
| Phone |
9986266576 |
| Fax |
|
| Email |
namratha.hegde@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Namratha Hegde |
| Designation |
Associate Professor |
| Affiliation |
Sankara College of Optometry |
| Address |
Department of Optometry, Sankara College of Optometry, Sankara Eye Hospital, Varthur Main Road, Kundalahalli Gate, Bangalore
Bangalore
KARNATAKA
560037
India |
| Phone |
9986266576 |
| Fax |
|
| Email |
namratha.hegde@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital, Varthur Main Road, Kundalahalli, Bengaluru, Karnataka, India 560037 |
|
|
Primary Sponsor
|
| Name |
Sankara Eye Hospital |
| Address |
Sankara Eye Hospital, Varthur Main road, Kundalahalli Signal, Bangalore, Karnataka, India 560037 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Namratha |
Sankara Eye Hospital |
Sankara Ey Hospital, Kundalahalli signal, Varthur Main Road,Bengaluru 560037
Bangalore
KARNATAKA |
9986266576
namratha.hegde@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sankara Eye Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G309||Alzheimers disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patient With Alzheimer Disease |
|
| ExclusionCriteria |
| Details |
Previous History Of Head Trauma
Other Ocular Condition
Disability(Severe) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluating NSUCO score for saccadic eye movement |
One time assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effects on the pattern of saccadic eye movement based on the severity of the disease ​ |
one day |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
28/11/2024 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
An Observation Study on the saccadic eye movement among Alzheimer’s diseased patients with an objective to assess the effect on pattern of saccadic eye movement with respect to the severity of the condition. The patients are recruited based on the inclusion and the exclusion criteria set. The Initial assessments include Demographic data, history, Visual Acuity, Refraction, Fundus Evaluation and MMSE. The Mini-Mental State Evaluation Score of the patient is assessed with the help of a questionnaire. Followed by assessment of the Saccadic Eye Movement Evaluation according to NSUCO’s Oculomotor Test. The study aims to compare the pattern of the saccadic eye movement with the severity of Alzheimer’s Disease, thus serving as a bio-marker for its severity. |