The aim of this study was to evaluate the effect of borderline hypercholesterolemia therapy in preventing the development of macular edema and diabetic retinopathy.
Inclusion criteria is Diabetic retinopathy and Borderline hypercholesterolemia and exclusion Criteria is CSME macular edema and proliferative Diabetic retinopathy. the sample size is 84 patients (42 patients in each groups). Patients in the intervention group received daily atorvastatin 20mg for 3 months and the control group patients were given placebo daily for 3 months. The main outcome of this trial was macular edema.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201709207466N5
Registration date:2017-10-31, 1396/08/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-31, 1396/08/09
Registrant information
Name
Reza Rezaei
Name of organization / entity
Ophtalmologist
Country
Iran (Islamic Republic of)
Phone
+98 912 239 1814
Email address
dr.rezarezaei@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Arak University Of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of treatment of borderline hypercholesterolemia on risk of macular edema
Public title
The effect of treatment of hypercholesterolemia on risk of macular edema
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Diabetic retinopathy; Borderline hypercholesterolemia; and having informed consent;
Exclusion Criteria: CSME macular edema; proliferative Diabetic retinopathy;
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
82
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij Square, Arak, Iran
City
Arak
Postal code
Approval date
2016-02-15, 1394/11/26
Ethics committee reference number
IR.Arak.mu.ac.1394.302
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E10, E11,
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
Macular Edema
Timepoint
Baseline, 3 Months later
Method of measurement
Test
Secondary outcomes
1
Description
Retinopathy
Timepoint
Baseline, 3 months Later
Method of measurement
Test
Intervention groups
1
Description
Daily, for 3 months, Atorvastatin 20 mg
Category
Treatment - Drugs
2
Description
Daily, for 3 months, Placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Kabir Hospital
Full name of responsible person
Dr Reza Rezaei
Street address
Amir Kabir Hospital, Vali-e Asr Street, Arak, Iran
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad arjomandzadegan
Street address
Arak University of Medical Sciences, Basij Sq., Arak, Iran
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Ali Arash Anoushirvani
Position
Deputy of Research
Other areas of specialty/work
Street address
Arak University of Medical Sciences
City
Arak
Postal code
0098
Phone
+98 86 3417 3645
Fax
Email
dr.anoushirvani@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Reza Rezaei
Position
Ophthalmology
Other areas of specialty/work
Street address
School of Medicine, Arak University of Medical Sciences, Arak, Iran
City
Arak
Postal code
0098
Phone
+98 86 3417 3645
Fax
Email
dr_rezarezaei85@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Reza Rezaei
Position
Ophthalmology, Assistant Prof
Other areas of specialty/work
Street address
School of Medicine, Arak University of Medical Sciences, Arak, Iran
City
Arak
Postal code
0098
Phone
+98 86 3417 3645
Fax
Email
dr_rezarezaei85@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)