Evaluation of comparative effect of intravitreal bevasizumab on visual acuity and central macular thickness in patient with central serous chorioretinopathy
Comparative effectiveness of intravitreal injection of bevacizumab on visual acuity and central macular thickness in patients with central serous chorioretinopathy ,
Inclusion criteria: Patients with visual loss (2 lines Snellen chart or more) and in scan (central macular thickness greater than 250 microns) Central serous chorioretinopathy diagnosis has been laid for them.
Exclusion criteria: Patients with adequate visual loss with pathological retinal diseases other than Central serous retinopathy and diabetic retinopathy and hypertensive retinopathy and retinal dystrophies and patients who do not have the desire to enter the study.
The study population:patients with Central serous chorioretinopathy reffered to Alzahra eye hospital
The sample volume:30 patients with Central serous chorioretinopathy .
Intervention:intravitreal injection of 1.25 mg bevacizumab after the diagnosis
Primary consequences :changes in visual acuity and central macllar thickness
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041533448N1
Registration date:2017-05-24, 1396/03/03
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-05-24, 1396/03/03
Registrant information
Name
Seyed Sajad Ahmadi
Name of organization / entity
Alzahra Eye Hospital
Country
Iran (Islamic Republic of)
Phone
+98 54 3323 3551
Email address
dr.sajadahmadi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zahedan University of Medical Sciences
Expected recruitment start date
2017-05-31, 1396/03/10
Expected recruitment end date
2017-09-01, 1396/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of comparative effect of intravitreal bevasizumab on visual acuity and central macular thickness in patient with central serous chorioretinopathy
Public title
Evaluation of treatment options of central serous chorioretinopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with visual loss (2 lines Snellen chart or more) and in scan (the thickness of the central part of the macula greater than 250 microns) diagnosis of central serous chorioretinopathy they laid is.
Exclusion criteria: Patient with visual loss with pathological retinal diseases other than Central serous retinopathy and diabetic retinopathy and hypertensive retinopathy and retinal dystrophies and patients who do not have the desire to enter the study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Ethics Committee of Zahedan University of Medical Sciene
Street address
Dr.Hesabi Squre
City
Zahedan
Postal code
98167-43463
Approval date
2017-03-07, 1395/12/17
Ethics committee reference number
IR. ZAUMS. REC.1395.109
Health conditions studied
1
Description of health condition studied
Central Serous Chorioretinoathy
ICD-10 code
H35.7
ICD-10 code description
Central Serous Chorioretinopathy
Primary outcomes
1
Description
Visual acuity
Timepoint
Before start the study and 2 months and 4 months after intervention
Method of measurement
Snellen acuity chart
Secondary outcomes
1
Description
Central Maclar Thickness
Timepoint
Before start the study and 2 months and 4 months after intervention
Method of measurement
Optical Coherence Tomography
Intervention groups
1
Description
Control group : without any intervention , just close abservation ( 15 patinets )
Category
Diagnosis
2
Description
Intervention group : 1.25 mg intravireal injection of bevasizumab , one time intravitreal injection ( 15 patinets )
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Eye Hospital Zahedan
Full name of responsible person
Seyed Sajad Ahmadi
Street address
Shahid Mottahari St , Zahedan
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Zahedan University of Medical Sciences
Full name of responsible person
Mohammad Reza Shahraki
Street address
Dr.Hesabi Squre
City
Zahedan
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, Zahedan 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
Vice chancellor for research, Zahedan University of Medical Sciences
Full name of responsible person
Mohammad Reza Shahraki
Position
Physiologist , Phd, Vice chancellor for research, Zahedan University of Medical Sciences
Other areas of specialty/work
Street address
Dr .Hesabi Squere , Zahedan
City
Zahedan
Postal code
Phone
+98 54 3329 5725
Fax
Email
m_Shahrakim@zaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Alzahra Eye Hospital Zahedan
Full name of responsible person
Alireza Maleki
Position
Vitreoretinal Fellowship , Associated Proffesor
Other areas of specialty/work
Street address
Shahid Mottahari St , Zahedan
City
Zahedan
Postal code
Phone
+98 543233551
Fax
Email
a_r_maleki@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Alzahra Eye Hospital Zahedan
Full name of responsible person
Seyed Sajad Ahmadi
Position
Ophthalmology Resident
Other areas of specialty/work
Street address
Shahid Mottahari St , Zahedan
City
Zahedan
Postal code
Phone
+98 543233551
Fax
Email
dr.sajadahmadi@zaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)