| CTRI Number |
CTRI/2024/08/072322 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
understanding the relation between vision loss, hope and quality of life in patients with low vision |
|
Scientific Title of Study
|
Relationship between Adaptation to Age Related Vision Loss, Hope, and Ocular Health related quality of life in individuals with Low vision. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Salandri Varshika Yadav |
| Designation |
Post graduate student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Room no:313 Department of Optometry, Manipal college of Health Professions, Manipal academy of higher Education (MAHE), Manipal, Udupi, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7022132075 |
| Fax |
|
| Email |
varshika.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Radhika |
| Designation |
Assistant professor - Senior scale |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of optometry, Manipal college of Health Professions, Manipal academy of higher Education, Manipal Udupi, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7349247049 |
| Fax |
|
| Email |
radhika.pu@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Radhika |
| Designation |
Assistant professor - Senior scale |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of optometry, Manipal college of Health Professions, Manipal academy of higher Education, Manipal Udupi, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7349247049 |
| Fax |
|
| Email |
radhika.pu@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Room no: 313 Department of optometry, Manipal college of Health Professions, Manipal academy of higher Education, Manipal Udupi, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Salandri Varshika Ydadav |
| Address |
Room no: 313 Department of optometry, Manipal college of Health Professions, Manipal academy of higher Education, Manipal Udupi, Karnataka 576104 |
| 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 |
| Dr Radhika |
Kasturba Hospital |
Department of ophthalmology, ROOM NO 9, 3rd floor, Kasturba Hospital, Manipal Academy of Higher Education, Manipal Udupi, Karnataka 576104
Udupi
KARNATAKA |
7349247069
radhika.pu@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: H542||Low vision, both eyes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Low vision patients including all ocular condition
2.Individual of both genders with visual acuity 6/18 or worse in the
stronger eye and 6/30 or worse in the weaker eye (with correction).
3.Individuals with previous history of
eye surgeries meeting low vision criteria post surgeries.
4.Newly diagnosed low vision individuals and
individuals undergoing low vision care follow-up |
|
| ExclusionCriteria |
| Details |
1.Visual impairment in patients with Mental Retarded, or individuals with Brain
related Disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual related quality of life
scale ranges from 0 to 100 |
One time measurement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Adaptation to age related vision loss scale ranges from 0 to 24.
The Adult Hope scale ranges from 12 to 96 |
One time measurement |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
20/08/2024 |
| 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)
|
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 - NO
|
|
Brief Summary
|
This study is a prospective observational study, where we are trying to determine the relationship between adaption to age related vision loss, Hope and ocular health related quality of life in individuals with low vision among age group between 40 to 60year old through 3 different types of questionnaires AVL scale, adult hope scale and vision function questionnaire, this study will be conducted in kasturba hospital,manipal india as well as District Hospital Udupi |