Study of the effect of hemodialysis on retinal and choroidal thickness in patients with chronic renal disease who underwent hemodialysis in the dialysis ward of Imam Khomeini Hospital
Study of the effect of hemodialysis on retinal and choroidal thickness in patients with chronic renal disease who underwent hemodialysis in the dialysis ward of Imam Khomeini Hospital
Design
This study is a nonblinded clinical trial. The study population will be included all patients with chronic kidney failure that referred to Imam Khomeini Hospital of Kermanshah. 83 eligible patients will be selected conveniently and will undergo dialysis
Settings and conduct
The study, which will be conducted at Imam Khomeini Hospital of Kermanshah, is not blinded one. In all patients, complete ophthalmologic examinations including IOP, VA and fundus examination, refraction and macular and choroidal OCT are performed 30 minutes prior to hemodialysis.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with chronic kidney failure
Exclusion criteria: Patients with a history of glaucoma, uveitis, macular disease, retinal diseases; Patients who have had a history of eye surgery, retinal laser therapy and intravitreal injections for the past three months;
Patients whose axial length is outside the range of 22 to 24 mm
Intervention groups
In the intervention group, the patient undergoes dialysis for 3 to 4 hours with a blood flow of 250 to 300 ml/min.
Main outcome variables
Retinal thickness; Choroidal thickness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N135
Registration date:2020-01-14, 1398/10/24
Registration timing:prospective
Last update:2020-01-14, 1398/10/24
Update count:0
Registration date
2020-01-14, 1398/10/24
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-30, 1398/11/10
Expected recruitment end date
2020-05-30, 1399/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of hemodialysis on retinal and choroidal thickness in patients with chronic renal disease who underwent hemodialysis in the dialysis ward of Imam Khomeini Hospital
Public title
The effect of hemodialysis on retinal and choroidal thickness in patients with chronic renal disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic kidney failure
Exclusion criteria:
Patients with a history of glaucoma, uveitis, macular disease, retinal diseases.
Patients who have had a history of eye surgery, retinal laser therapy and intravitreal injections for the past three months.
Patients whose axial length is outside the range of 22 to 24 mm.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
83
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly Individually by random number table via code receiption
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-06-26, 1398/04/05
Ethics committee reference number
ir.kums.rec.1398.937
Health conditions studied
1
Description of health condition studied
Chronic renal failure
ICD-10 code
N18.1
ICD-10 code description
Chronic kidney disease, stage 1
Primary outcomes
1
Description
Retinal thickness
Timepoint
The beginning and the end of the study
Method of measurement
Using Optical coherence tomography (OCT)
2
Description
Choroidal thickness
Timepoint
The beginning and the end of the study
Method of measurement
Using Optical Coherence Tomography (OCT)
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, a complete eye examination is performed 30 minutes before the start of the study. Then the patient undergoes dialysis for 3 to 4 hours with a blood flow of 250 to 300 ml/min. After the end of the study, an eye examination is performed again and the effects of the intervention will be assessed before and after the study.
Category
Treatment - Other
2
Description
The control group will not receive any intervention
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Sasan Beyranvand
Street address
Street Naghliyeh, Imam Khomeini Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3728 3602
Email
sasan.beyranvand@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sasan Beyranvand
Position
Resident of Ophthalmology
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Street Naghliyeh, Imam Khomeini Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3728 3602
Email
sasan.beyranvand@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Fariba Shaikhi Shoshtari
Position
Member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Street Naghliyeh, Imam Khomeini Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3728 3602
Email
dr.shaikhi64@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sasan Beyranvand
Position
Resident of Ophthalmology
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Street Naghliyeh, Imam Khomeini Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3728 3602
Email
sasan.beyranvand@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
3 momths
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail