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CTRI Number  CTRI/2024/08/071866 [Registered on: 02/08/2024] Trial Registered Prospectively
Last Modified On: 01/08/2024
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  
Name  Address 
NIL  NIL 
 
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  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Devaraj Urs Central Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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)= "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)   12/08/2024 
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  
Glaucoma is the worldwide leading cause of irreversible blindness. The global prevalence of glaucoma for the age range 40-80 years is between 3 and 4%, which will result in approximately 110–120 million glaucoma patients in 2040.1
It is an optic neuropathy with multifactorial etiology of which elevated intraocular pressure (IOP) remains the focus of its treatment. But some glaucoma patients continue to experience optic nerve damage despite decreased IOP.2
However, risk factors other than IOP, such as impaired microvascular circulation, vascular injury, and oxidative stress or hypoxia, are also related to the pathogenesis of glaucoma.3
Altered ocular blood flow was reported to accelerate the development and progression of the disease in such patients. Also, medical conditions that negatively affect ocular blood flow will obviously cause ischemia and reperfusion damage in glaucoma patients and in individuals prone to glaucoma.
Hemodialysis (HD) an important component of the treatment of Chronic Kidney Disease (CKD) that eliminates osmotically active materials, resulting in fluid loss of the body and blood osmolarity.4 And intensive ultrafiltration is usually the factor that precipitates arterial hypotension in these patients. 
A strong correlation exists between glaucomatous optic nerve damage and the presence of low diastolic arterial pressure, which gives rise to inadequate ocular perfusion pressure (OPP) explained by the "vascular hypothesis” which suggests that abnormal perfusion of the optic disc is a primary cause of glaucomatous damage.5
Some studies indicate varying effects on IOP during hemodialysis—some report increases, some decreases, and others note no significant changes.
Hence, we intend to study the effect of hemodialysis on the intraocular pressure, ocular perfusion pressure, systolic and diastolic arterial pressures in patients with end-stage renal disease.
The kidney and eye share striking structural, developmental, physiological, and pathogenic pathways. For example, both the glomerulus and choroid have extensive vascular networks of similar structure; the inner retina and glomerular filtration barrier share similar developmental pathways, and the renin–angiotensin–aldosterone hormonal cascade is found in both the eye and the kidney.
The composition and osmolarity of the aqueous humor are similar to the plasma; nevertheless, it has a lower protein concentration and a lower concentration of glucose and urea.
It is thought that an electrolyte and osmolarity disequilibrium might lead to a rise in IOP, since with the reductions in body fluid volume and osmotic pressure caused by HD, the amount of aqueous humor declines mainly by changes in intraocular osmotic pressure rather than plasma osmolality.6
Several studies have investigated how HD affects IOP, but the results have not been consistent. Some studies suggest that it increases during HD, while others indicate that it decreases or remains unchanged during or after the procedure.7
Also, there are instances of transient vision blurring, increased IOP, glaucoma, and retroocular pain during hemodialysis.8
In a retrospective study Glaucoma consecutively developed in 4.3% in the CKD group and 2.8% in the control group (P < 0.0001). CKD increased the risk of glaucoma development.3 
Hemodialysis can lead to changes in fluid balance and hemodynamic status, which can affect ocular perfusion and potentially lead to changes in retinal and peripapillary retinal nerve fiber layer thickness. 9
 
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