Comparison of efficacy of early vitrectomy and vitreous tap and injection in patients refering to Farabi Eye Hospital with diagnosis of post cataract surgery acute endophthalmitis and visual acuity of hand motion
Comparison of efficacy of early vitrectomy and vitreous tap and injection in patients refering to Farabi Eye Hospital with diagnosis of post cataract surgery acute endophthalmitis and visual acuity of hand motion
Design
Non randomized clinical trial , parallel arm groups, non randomized, 65 cases
Settings and conduct
Patient refering to Farabi eye Hospital with diagnosis of post cataract surgery endophthalmitis goes under vitrectomy
Participants/Inclusion and exclusion criteria
Patient with diagnosis of post cataract surgery endophthalmitis
Intervention groups
One group goes under early vitrectomy; another one goes under intravitreal antibiotic injection
Main outcome variables
Visual acuity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200115046148N1
Registration date:2020-02-10, 1398/11/21
Registration timing:registered_while_recruiting
Last update:2020-02-10, 1398/11/21
Update count:0
Registration date
2020-02-10, 1398/11/21
Registrant information
Name
soran aminzade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 4244 4148
Email address
s-aminzade@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-29, 1398/11/09
Expected recruitment end date
2021-01-28, 1399/11/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of early vitrectomy and vitreous tap and injection in patients refering to Farabi Eye Hospital with diagnosis of post cataract surgery acute endophthalmitis and visual acuity of hand motion
Public title
Comparison of efficacy of early vitrectomy and vitreous tap and injection in patients refering to Farabi Eye Hospital with diagnosis of post cataract surgery acute endophthalmitis and visual acuity of hand motion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Post cataract surgery endophthalmitis
Exclusion criteria:
Any condition or disorder which affect visual acuity like diabetic retinopathy , glaucoma , retinal disorder and etc
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
65
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Research Ethics Committee Farabi Eye Hospital- Tehran University of Medical Sciences
Street address
Farabi hospital, Qazvin Square, South Kargar Ave., Tehran
City
Tehran
Province
Tehran
Postal code
5913813111
Approval date
2019-02-12, 1397/11/23
Ethics committee reference number
IR.TUMS.FARABIH.REC.1398.006
Health conditions studied
1
Description of health condition studied
Post cataract surgery Endophthalmitis
ICD-10 code
H44.0
ICD-10 code description
Purulent endophthalmitis
Primary outcomes
1
Description
Visual acuity
Timepoint
1 , 3 ,6 months afetr intervention
Method of measurement
Based on snelen chart and LogMAR
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: early vitrectomy; patients of this group who selected according to condition formerly explained will go on vitrectomy without any intervention priorly. Vitrectomy will be done through pars plana with small gauge needles and pus in the vitreous will be extracted by the way.
Category
Treatment - Surgery
2
Description
Control group: Intravitreal antibiotic injection; Vancomycin 1mg / 0.1 ml and ceftazidime 2.25 mg / 0.1 ml . The injection will be done and if the condition deteriorates during serial visits , the patient will go on delayed vitrectomy.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi Hospital
Full name of responsible person
Soran Aminzade
Street address
Qazvin Square , S kargar Ave , Tehran
City
Tehran
Province
Tehran
Postal code
5913813111
Phone
+98 21 5542 6283
Email
soranaminzade90@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shokufeh Nikfar
Street address
Qazvin Square , S kargar Ave , Tehran
City
Tehran
Province
Tehran
Postal code
5913813111
Phone
+98 21 5542 6283
Email
soranaminzade90@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Soran Aminzade
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Qazvin square, South Kargar St., Tehran
City
Tehran
Province
Tehran
Postal code
5913813111
Phone
+98 21 5542 6283
Email
soranaminzade90@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Soran Aminzade
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Qazvin square, South Kargar St., Tehran
City
Tehran
Province
Tehran
Postal code
5913813111
Phone
+98 21 5542 6283
Email
soranaminzade90@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Soran Aminzade
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Qazvin square, South Kargar St., Tehran
City
Tehran
Province
Tehran
Postal code
5913813111
Phone
+98 21 5542 6283
Email
soranaminzade90@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
Data related to visual acuity and complications of surgery can bbe shared
When the data will become available and for how long
After sudy ends up
To whom data/document is available
No limitation
Under which criteria data/document could be used
No limitation
From where data/document is obtainable
soranaminzade90@gmail.com
What processes are involved for a request to access data/document
Afetr an email request , data will be sent as soon as possible