Determine the effect of early vitrectomy on patients with Endophthalmitis
Design
Single arm clinical trial, with 24 patients, enrolled between November 2020 and March 2021, and will be followed for 3 months. Randomization and Blinding is not applicable.
Settings and conduct
This study will be performed in Feiz hospital, Isfahan, Iran. Patients will be included based on inclusion and exclusion criteria. Visual acuity of patients will be assessed at base line, one and three months after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with endophthalmitis after cataract surgery; Exclusion criteria: patients who receive inter-vitreous antibiotics injection
Intervention groups
Intervention group: In intervention group, early vitrectomy will be performed
Main outcome variables
Visual acuity, Retinal detachment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201103049247N1
Registration date:2020-11-15, 1399/08/25
Registration timing:prospective
Last update:2020-11-15, 1399/08/25
Update count:0
Registration date
2020-11-15, 1399/08/25
Registrant information
Name
Hadi Vaezi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3236 4845
Email address
mhadivaezi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of early vitrectomy on visual acuity of patients with endophthalmitis
Public title
Early vitrectomy for the treatment of endophthalmitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Endophthalmitis after the cataract surgery
Exclusion criteria:
patients who receive intra-viterous antibiotic injection
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
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, Hezarjerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-10-24, 1399/08/03
Ethics committee reference number
IR.MUI.MED.REC.1399.648
Health conditions studied
1
Description of health condition studied
Endophthalmitis
ICD-10 code
H44.0
ICD-10 code description
Purulent endophthalmitis
Primary outcomes
1
Description
Visual acuity
Timepoint
Before the intervention, one month and three months after the intervention
Method of measurement
Snellen chart
2
Description
Retinal detachment
Timepoint
Before the intervention, one month and three months after the intervention
Method of measurement
Physical exam
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group undergo early vitrectomy. This is done by washing the front room. A deep vitrectomy will then be performed. Depending on the condition of the retina, silicone oil will be injected and the periphery of retina will be checked at the end. Antibiotics will be injected into the vitreous and, if necessary, the trocar site will be sutured.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Feiz hospital
Full name of responsible person
Farhad Fazel
Street address
Modares St., Ghods Sq.
City
Isfahan
Province
Isfehan
Postal code
8149644874
Phone
+98 31 3445 2034
Email
fazel43@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Hezarjerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
research@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
Hadi Vaezi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
No. 51, Masrour Alley, Abbas abad St.
City
Isfahan
Province
Isfehan
Postal code
8134718841
Phone
+98 31 3236 4845
Fax
Email
mhadivaezi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hadi Vaezi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
No. 51, Masrour Alley, Abbas abad St.
City
Isfahan
Province
Isfehan
Postal code
8134718841
Phone
+98 31 3236 4845
Fax
Email
mhadivaezi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hadi Vaezi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
No. 51, Masrour Alley, Abbas abad St.
City
Isfahan
Province
Isfehan
Postal code
8134718841
Phone
+98 31 3236 4845
Fax
Email
mhadivaezi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available