| CTRI Number |
CTRI/2025/03/081530 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
23/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of Ocular Fundus Changes in Patients With Chronic Kidney Disease. |
|
Scientific Title of Study
|
Assessment of Fundus Changes in Patients With Chronic Kidney Disease in a Tertiary Health Care Centre in Coimbatore |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mathan G |
| Designation |
MBBS Student |
| Affiliation |
KMCH Institute of Health Sciences and Research |
| Address |
Department of Ophthalmology, A block, 3rd floor, Room no: North 8, KMCH Institute of Health Sciences and Research, 99, Civil Aerodrome Avinashi Road, Coimbatore
Coimbatore
TAMIL NADU
641014
India |
| Phone |
7339290844 |
| Fax |
|
| Email |
nsgmathan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nithyapriya C |
| Designation |
MS(Ophthalmology) |
| Affiliation |
KMCH Institute of Health Sciences and Research |
| Address |
Assistant Professor,
Department of Ophthalmology, A block, 3rd floor, Room no: North 8, KMCH Institute of Health Sciences and Research, 99, Civil Aerodrome Avinashi Road, Coimbatore
Coimbatore
TAMIL NADU
641014
India |
| Phone |
9994996391 |
| Fax |
|
| Email |
svnithyapriya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mathan G |
| Designation |
MBBS Student |
| Affiliation |
KMCH Institute of Health Sciences and Research |
| Address |
Department of Ophthalmology, A block, 3rd floor, Room no: North 8, KMCH Institute of Health Sciences and Research, 99, Civil Aerodrome Avinashi Road, Coimbatore
Coimbatore
TAMIL NADU
641014
India |
| Phone |
7339290844 |
| Fax |
|
| Email |
nsgmathan@gmail.com |
|
|
Source of Monetary or Material Support
|
| KMCH Institute of Health Sciences and Research, 99, Civil Aerodrome Avinashi Road, Coimbatore , TamilNadu, India. 641014 |
|
|
Primary Sponsor
|
| Name |
Mathan G |
| Address |
KMCH Institute of Health Sciences and Research, Coimbatore. 641014 |
| Type of Sponsor |
Other [Investigator initiated] |
|
|
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 |
| Mathan G |
KMCH Institute of Health Sciences and Research |
Department of Ophthalmology, A block, 3rd floor, Room no: North 8, No:99, Civil Aerodrome Avinashi Road, Coimbatore , TamilNadu, India. 641014
Coimbatore
TAMIL NADU |
7339290844
nsgmathan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H350||Background retinopathy and retinalvascular changes, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of chronic kidney disease of age above 18 of both sexes |
|
| ExclusionCriteria |
| Details |
-Cases of reversible kidney injury
-Renal transplant recipients
-Patients on maintenance hemodialysis
-Patient who refuses consent
-Patient with any renal congenital anomaly |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of morphological changes of fundus in CKD patients and the proportion of various fundus pathology is charted.
|
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Better treatment methodology is suggested in advance and prevents the progression of disease |
12 months |
|
|
Target Sample Size
|
Total Sample Size="179"
Sample Size from India="179"
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)
|
10/03/2025 |
| 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 Applicable |
| 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
|
METHODOLOGY: 1. CKD patients reported with ocular anomalies to the Department of Ophthalmology / referred by the Department of General Medicine will be undertaken as subject for the Prospective Observational Study
2. Fundus examination for the patients will be carried out under eye examination unit and instruments like slit lamp bio microscope, Retinoscope (mirror and streak), Direct and indirect ophthalmoscope will be used and adequate data will be collected
3. Following appropriate protocol, assuring quality control, and assessing through standard calibrated instruments, morphology findings will be captured (colored and labelled pictures)and categorized. Data collected will be recorded with the help of various statistical tools
4. Through maintaining confidentiality and following ethical principles, the data collected from the patient population will be analyzed and categorized according to varying degree of fundus changes
5. Fundus anomalies like DR, PDR, NPDR, Hypertensive retinopathy, Mixed retinopathy, Venous occlusions, Age related Macular Degeneration Drusen like deposits, Optic atrophy and retinal detachment are categorized and segregated in groups. Incidence and proportion of varying fundus changes in a tertiary health care centre is reported
Prior studies indicated a high prevalence of ocular fundus pathology among patients with chronic kidney disease (CKD). The risk of development of retinopathy was significantly higher among older patients those with low haemoglobin level and high blood pressure. Retinopathy was significantly increased with reduction of e-GFR. There was no direct significant relationship between BMI and serum lipid levels with retinal abnormality. The current study provides the morphological changes of fundus and the proportion of varying degree of fundus changes in CKD patients in a tertiary health care centre, Coimbatore, Tamil Nadu. Thus it assist in improving the treatment protocols in terms of whether to treat or not treat/ whether to intensify or not to intensify therapy in order to minimise the major avoidable fundus complications in chronic kidney failure patients and this helps to narrow down ocular complications in advance. |