| CTRI Number |
CTRI/2024/07/071533 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
06/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
In end stage kidney failure Patients screening of ocular parameters and visual related quality of life |
|
Scientific Title of Study
|
Screening of ocular parameters and visual related quality of life among individuals with end stage kidney disease on maintenance hemodialysis |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhimagani Latha sri |
| Designation |
1st year Master of Optometry student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Optometry
Manipal College of Health Professions
Manipal Academy of Higher Education
Manipal
Udupi district Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9618659894 |
| Fax |
|
| Email |
bhimagani.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Preethi Naik |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Optometry
Manipal College of Health Professions
Manipal Academy of Higher Education
Manipal
Udupi district Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8105619834 |
| Fax |
|
| Email |
preethi.naik@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Bhimagani Latha sri |
| Designation |
1st year Master of Optometry student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Optometry
Manipal College of Health Professions
Manipal Academy of Higher Education
Manipal
Udupi district Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9618659894 |
| Fax |
|
| Email |
bhimagani.mchpmpl2023@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Optometry, Manipal College of Health Professions,
Manipal Academy of Higher Education,
Manipal,
Karnataka,
India, 576104
|
|
|
Primary Sponsor
|
| Name |
Bhimagani Latha sri |
| Address |
Department of Optometry
Manipal college of Health Professions
Manipal Academy of Higher Education
Manipal
Udupi district
Karnataka
India
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 |
| Bhimagani Latha sri |
KASTURBA HOSPITAL |
Dialysis unit, Nephrology department, Kasturba Hospital
Manipal, Karnataka, India, 576104
Udupi
KARNATAKA |
9618659894
bhimagani.mchpmpl2023@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: H538||Other visual disturbances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not Applicable, no comparator agent |
not Applicable, no comparator agent |
| Intervention |
not applicable, no intervention agent |
not applicable, no intervention agent |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Age more than 18 years old
2. Both males and females
3. Individuals with end-stage kidney disease on maintenance hemodialysis |
|
| ExclusionCriteria |
| Details |
1.Any connective tissue diseases or genetic conditions
2. Patients using dry eye or anti-glaucoma medications
3. H/o wearing contact lenses
4. Patients with a history of ocular injury or post-operative complications |
|
|
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 |
one time measurement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| visual acuity, contrast sensitivity, Intra ocular pressure, Schirmer test values Changes |
Before 30 minutes and After 30 minutes of hemodialysis |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
Final Enrollment numbers achieved (Total)= "78"
Final Enrollment numbers achieved (India)="78" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/08/2024 |
| Date of Study Completion (India) |
27/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
27/03/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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 is a prospective observational, single center study Screening of ocular parameters and visual-related quality of life among
individuals with end-stage kidney disease on maintenance hemodialysis in 78 patients with end stage kidney disease that will be conducted in dialysis unit, Nephrology department, Kasturba hospital, India. primary outcome will be administration of visual-related quality of life questionnaire among individuals with end-stage kidney
disease on maintenance hemodialysis. The secondary outcome will be assessment of the variation in the ocular parameters changes among individuals with end-stage kidney
disease on maintenance hemodialysis. |