| CTRI Number |
CTRI/2024/08/071866 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
12/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of changes in Eye Blood Flow in Kidney Disease Patients on Dialysis |
|
Scientific Title of Study
|
Ocular Hemodynamic Variations in Chronic Kidney Disease Patients on Hemodialysis - An Observational Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nakkana Rachana |
| Designation |
Junior Resident |
| Affiliation |
Sri Devaraj Urs Academy Of Higher Education And Research |
| Address |
OPD NO 22
Department of Ophthalmology
Sri Devaraj Urs Medical College And Research Centre
Kolar
KARNATAKA
563101
India |
| Phone |
7780394835 |
| Fax |
|
| Email |
rachanasonu16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sangeetha T |
| Designation |
Professor And HOD |
| Affiliation |
Sri Devaraj Urs Academy Of High Education And Research |
| Address |
Department Of Ophthalmology
Sri Devaraj Urs Medical College And Research Centre Kolar
Kolar
KARNATAKA
563101
India |
| Phone |
9880031831 |
| Fax |
|
| Email |
sangeetha31jayakumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sangeetha T |
| Designation |
Professor And HOD |
| Affiliation |
Sri Devaraj Urs Academy Of Higher Education And Research |
| Address |
Department Of Ophthalmology
Sri Devaraj Urs Medical College And Research Centre Kolar
Kolar
KARNATAKA
563101
India |
| Phone |
9880031831 |
| Fax |
|
| Email |
sangeetha31jayakumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Devaraj Urs Academy Of Higher Education And Research, Tamaka Kolar Karnataka-563101 India |
|
|
Primary Sponsor
|
| Name |
Sri Devaraj Urs Academy Of Higher Education And Research |
| Address |
Tamaka Kolar
Karnataka - 563101 India |
| Type of Sponsor |
Private medical college |
|
|
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 Nakkana Rachana |
Sri Devaraj Urs Academy Of Higher Education |
NO: 22, Department Of Ophthalmology, First Floor, R.L.Jallappa Hospital And Research, Tamaka, Kolar-563101
TAMAKA KOLAR
Kolar
KARNATAKA |
7780394835
rachanasonu16@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Devaraj Urs Central Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Negative history of glaucoma
2. Healthy corneas
3. IOP 10-21mmHg
who have undergone dialysis for more than 4 weeks |
|
| ExclusionCriteria |
| Details |
1. Uveitis
2. Diabetic retinopathy with elevated IOP
3. Corneal pathology
4. IOP more than 21MMHG before dialysis
5. Optic nerve abnormalities indicative of glaucoma |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the changes in intraocular pressure, central corneal thickness and Serum osmolality |
Before and after dialysis (after 4 hours) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the relationship between Chronic Kidney Disease & thickness of retinal nerve fibre layer by taking OCT |
Before & after Hemodialysis in Chronic Kidney Disease Patients |
|
|
Target Sample Size
|
Total Sample Size="113"
Sample Size from India="113"
Final Enrollment numbers achieved (Total)= "113"
Final Enrollment numbers achieved (India)="113" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/08/2024 |
| Date of Study Completion (India) |
23/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Manuscript under revision. Will be sent for publication. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
OCULAR HEMODYNAMIC VARIATIONS IN CHRONIC KIDNEY DISEASE PATIENTS UNDERGOING HEMODIALYSIS Purpose: To evaluate the effect of haemodialysis on intraocular pressure (IOP), ocular perfusion pressure (OPP) & retinal nerve fibre layer (RNFL) thickness in chronic kidney disease (CKD) patients. Methods: Prospective study included 113 CKD patients on maintenance haemodialysis underwent pre- and post-dialysis assessment of IOP, OPP, blood pressure, and serum osmolality. RNFL thickness was measured using OCT. Results: Mean arterial pressure increased from 103.1±11.9 to 107.3±11.6 mmHg (p<0.01), Mean IOP from 17.9±1.8 to 18.8±1.7 mmHg and OPP from 72.9±12.3 to 75.1±14.0 mmHg (p<0.01). Serum osmolality showed no significant correlation with changes in IOP nor OPP. Mean RNFL thickness showed no significant association with CKD stage or renal biochemical parameters. Conclusion: Haemodialysis significantly alters systemic & ocular hemodynamic, increasing IOP and OPP, highlighting the need for periodic ocular monitoring for early detection of individuals at glaucoma risk in dialysis patients. |