Effect of dorzolamide drop with intravitreal avastin injection in decreasing central macular thickness in diabetic patient with diabetic macular edema that refer to Isfahan Feiz eye center 2017-18
Design
Clinical trials with control group, with parallel and randomized groups and double blind
Settings and conduct
Patients were collected in Feyz Hospital in Isfahan in an accessible manner. The left or right eyes of the patients were randomly assigned to the intervention group using a lottery envelope. Before and after treatment, the amount of visual activity was measured and according to Macular Cochran eye imaging, Foya thickness and macular volume. Patient and researcher did not know the contents of the therapeutic package used in the operating room.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Diabetic patients with retinopathy who have macular edema.
A transparent mediator for a thorough examination
Visual activity of both eyes are better than 1/10 and less than or equal to 4/10
Patient consent.
The thickness of the central area of the macula at the start of treatment is greater than 300 microns
Exclusion Criteria:
History of bone surgery
The presence of atrophy, oscillas, fibrosis and hard exudates in the macular center that affects vision.
Uncontrolled blood pressure, myopia of more than 8 diopters, active eye infectious disease, other complications of diabetes in the eyes and synchronous eye pathologies.
Intervention groups
Intravascular injection of Avastin was performed for all eyes at the start of treatment and 1 month later. In the intervention group, drops were given to the topical drops and in the control group, artificial tear drops were dropped every 12 hours and continued for 2 months.
Main outcome variables
Sight strength, Foie thickness, Macular volume
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131229015975N5
Registration date:2019-09-05, 1398/06/14
Registration timing:retrospective
Last update:2019-09-05, 1398/06/14
Update count:0
Registration date
2019-09-05, 1398/06/14
Registrant information
Name
Mohsen Pourazizi
Name of organization / entity
Semnan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 23 1445 1385
Email address
m.pourazizi@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
2017-09-23, 1396/07/01
Actual recruitment end date
2018-03-21, 1397/01/01
Trial completion date
2018-09-23, 1397/07/01
Scientific title
Effect of dorzolamide drop with intravitreal avastin injection in decreasing central macular thickness in diabetic patient with diabetic macular edema
Public title
Effect of dorzolamide drop with intravitreal avastin injection in decreasing central macular thickness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic patients with retinopathy who have macular edema due to increased macular thickness or vision loss are indicative of anti-VEGF treatment.
A transparent mediator for a thorough examination
Visual activity of both eyes are better than 1/10 and less than 4/10
Patient consent to Participate in the Study
The thickness of the central area of the macula at the start of treatment is greater than 300 microns
Exclusion criteria:
History of bone surgery
The presence of atrophy, scarring, fibrosis and hard exudates in the macular center that affects visual acuity.
Uncontrolled blood pressure
Presence of active eye infectious disease
There are other complications of diabetes in the eyes, which leads to an increase in the thickness of the macula.
The presence of other synchronous eye pathologies such as glaucoma and cataracts.
Age
From 18 years old to 62 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
16
Actual sample size reached:
16
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were selected in a non-probable manner, but the patients' eyes were randomly assigned to two groups of intervention and control based on the lottery.
Blinding (investigator's opinion)
Double blinded
Blinding description
Each eye was randomly assigned to receive one group of the medication. All preparations were individually prepared for each patient and patients and investigators were kept blinded to the randomized allocation and details of series of the medications throughout the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2017-09-22, 1396/06/31
Ethics committee reference number
IR.MUI.IRC.1396.3.651
Health conditions studied
1
Description of health condition studied
Edema macula
ICD-10 code
H58.8
ICD-10 code description
Other specified disorders of eye and adnexa in diseases classified elsewhere
Primary outcomes
1
Description
visual activity
Timepoint
Before and two months after the intervention.
Method of measurement
Examination by ophthalmologist
2
Description
Foie thickness
Timepoint
Before and two months after the intervention.
Method of measurement
Optical Coherence Topography and Examination by ophthalmologist
3
Description
Macular volume
Timepoint
Before and two months after the intervention.
Method of measurement
Optical Coherence Topography and Examination by ophthalmologist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 16 diabetic patients with elevated double-walled macular thickness in one eye randomly selected in addition to intravascular injection of Avastin at baseline and 1 month later, Dorzolamide topical drops were dropped every 1 to 12 hours and continued for 2 months. Found.
Category
Treatment - Other
2
Description
Control group: 16 diabetic patients with bilateral double-blind macular thickness in one eye randomly selected, in addition to intravascular injection of avastin at the start of treatment, and 1 month later, artificial tear drop was dropped every 1 to 12 hours and continued for 2 months.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Feyz Hospital in Isfahan
Full name of responsible person
Farhad Fazel
Street address
Quds Square.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
fazel@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ziba faraj Zadegan
Street address
Deputy of research of Isfahan University of Medical Sciences, Hezar jerib Avenue.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mohsen Pourazizi
Position
OphtHalmologist Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Feiz Hospital
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3445 2031
Fax
Email
m.pourazizi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farhad Fazel
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
fazel43@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Hossein Nikpour
Position
M.D.
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
hoseinmorado@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
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All information is unpublished after being denied and two years after the publication of the article.
When the data will become available and for how long
two years after the publication of the article
To whom data/document is available
Medical students and professors and specialized assistants of the ophthalmology group.
Under which criteria data/document could be used
To compare existing information with similar results at another time or other implementation.
From where data/document is obtainable
Send a request for cooperation to fazel43@yahoo.com and get permission from the Research Vice-Dept of Isfahan University of Medical Sciences.
What processes are involved for a request to access data/document
Send a request for cooperation to fazel43@yahoo.com and get permission from the Research Vice-Dept of Isfahan University of Medical Sciences.