Possible effect of statin use on the occurrence of retinal detachment secondary to PVR in patients with a history of successful vitrectomy or scleral buckling surgery referred to Rassoul Akram Ophthalmology Clinic, Randomized Clinical Trial
statin could reduce the incidence of secondary retinal detachment in patients with a history of successful vitrectomy or scleral buckle
Design
pilot RCT, 2 arm parallel-group, triple blinded, 3rd phase, single center
Settings and conduct
110 patients ( divided into 2 groups; 1, treatment group, using Atorvastatin 40mg for 3 months and 2, control group, using a placebo for 3 months). patients will be visited at 1 day, 1 week and 1, 3 and 6 months after the surgery. all patient's data will be recorded completely. the lab test will be done for each patient.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
age>40
primary attachment following PPV with silicone oil or sf6 tamponade vs scleral buckle
regular follow up
all of the surgery was done with a single surgeon in a single center
exclusion criteria:
1.combined RD
2.recurrent RD
3.RRD associated with a giant tear
4.Secondary RD due to other than PVR
5.intraoperative complications like vitreous or suprachoroidal hemorrhages
6.concomitant eye diseases affecting the retina including glaucoma, CSR, acquired and congenital retinal dystrophies, etc.
7.PVRc
8.lactation and pregnancy
9.systemic steroid use
10.Taking different medications that can interfere with statin use
Intervention groups
110 patients ( divided into 2 groups; 1, treatment group, using Atorvastatin 40mg for 3 months and 2, control group, using a placebo for 3 months).
Atorvastatin is made with Actover company
Main outcome variables
retinal redetachment secondary to PVR
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191207045645N1
Registration date:2020-06-08, 1399/03/19
Registration timing:registered_while_recruiting
Last update:2020-06-08, 1399/03/19
Update count:0
Registration date
2020-06-08, 1399/03/19
Registrant information
Name
Fatemeh Abdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8826 2137
Email address
abdi.fa@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-16, 1398/09/25
Expected recruitment end date
2021-12-16, 1400/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Possible effect of statin use on the occurrence of retinal detachment secondary to PVR in patients with a history of successful vitrectomy or scleral buckling surgery referred to Rassoul Akram Ophthalmology Clinic, Randomized Clinical Trial
Public title
statin in PVR related redetachment
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
age>40
primary attachment following PPV with silicon oil or sf6 tamponade vs scleral buckle
regular follow up
all of the surgery was done with a single experienced surgeon in a single center
Exclusion criteria:
combined RD
recurrent RD
RRD associated with giant tear
Secondary RD due to other than PVR
intraoperative complications like vitreous or suprachoroidal hemorrhages
Other concomitant eye diseases affecting the retina including glaucoma, CSR, acquired and congenital retinal dystrophies, etc.
PVRc
lactation and pregnancy
systemic steroid use
Taking different medications that can interfere with statin use
Age
From 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
online randomization system (https:// www.randomization.com)
block randomization
block size: 4
with 1 by 1 proportion
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study participants were not aware of the intervention type because the main drug and placebo were not distinguishable.
The principal investigator who evaluates the outcome is also unaware of the type of intervention because the medication is prescribed by another person performing the randomization.
The analyzer is also supposed to analyze the data as two groups a and b, the type of intervention is unknown.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Iran university of medical science
Street address
Iran university of medical science, Hemmat highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-12-16, 1398/09/25
Ethics committee reference number
IR.IUMS.REC.1398.980
Health conditions studied
1
Description of health condition studied
secondary retinal detachment
ICD-10 code
H33.0
ICD-10 code description
Retinal detachment with retinal break
Primary outcomes
1
Description
secondary retinal detachment
Timepoint
1 day, 1 week and 1,3 and 6 months after the surgery
Method of measurement
examinations and OCT imaging
Secondary outcomes
1
Description
comparing the rate of retinal detachment in groups of using statin and using placebo
Timepoint
day 1, week 1, month 1,3 and 6
Method of measurement
slit lamp examination and OCT
Intervention groups
1
Description
Intervention Group: Use of Atorvastatin 40 mg (Actover Pharmaceutical Company) daily for 3 months after successful vitrectomy or scleral buckling surgery for retinal detachment.
Category
Treatment - Drugs
2
Description
Control group: Use of placebo (Actover Pharmaceutical Company) daily for 3 months after successful vitrectomy or scleral buckling surgery for retinal detachment.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat e rasool e akram hospital
Full name of responsible person
Fatemeh Abdi
Street address
Sattarkhan
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2473
Fax
Email
iumseyedept@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Iran University of Medical Sciences
Full name of responsible person
Abbas Motevalian
Street address
Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
motevalian.a@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Iran 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
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Abdi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Hazrat e Raool Akram hospital, Sattarkhan
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2473
Email
fatemeh.abdi62@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Abdi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Hazrat e Raool Akram hospital, Sattarkhan
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2473
Email
fatemeh.abdi62@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Abdi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Hazrat e Raool Akram hospital, Sattarkhan
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2473
Email
fatemeh.abdi62@yahoo.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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
clinical data and examination without any clue of patients identifications are available
When the data will become available and for how long
after registry of all date (2 months after the last examination)
To whom data/document is available
all staff related to the university
Under which criteria data/document could be used
clinical data and examination and analysis results without any clue of patients identifications are available
From where data/document is obtainable
Fateme Abdi
What processes are involved for a request to access data/document
A written request will be received by Dr. Fatemeh Abdi and regarding the request, the time of publishment will be announced