Today pseudophakic macular edema is a frequent cataract surgery complication. Inflammation is the major etiologic factor in the development of cystoid macular edema (CME) following cataract surgery.Adalimumab (Humira) is a TNF inhibitor which has been approved in the United States in addition to infliximab and Etanercept. The present study will be carried out, since no study has been done to determine the effect of Adalimumab in pseodophakic macular edema. Clinical examination include: best-corrected visual acuity (BCVA), applanation tonometry, fundus examination and OCT. A vial of adalimumab (Humira) containing 40 mg/0.8 ml will be mixed with 0.8 ml of balanced salt solution (BSS), and 0.08 ml (2 mg of adalimumab) of this solution will be prepared for each patient. After preparing the eye in a standard fashion using 5 % povodine/iodine, an eyelid speculum will be used to stabilize the eyelids, and the injection of 1 mg (0.05 ml) will be performed 3.5 – 4 mm posterior to the limbus, through the inferotemporal pars plana with a 30-gauge needle under topical anesthesia or subconjunctival lidocaine. After the injection patients will be instructed to administer topical antibiotics for 3 days. All patients will be given detailed post-injection instructions and to call if any pain or significant changes in vision. The patients were examined with slit-lamp biomicroscope and OCT .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016100430130N1
Registration date:2016-12-03, 1395/09/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-03, 1395/09/13
Registrant information
Name
Mohsen Farvardin jahromi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 2830
Email address
farvardm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2016-10-16, 1395/07/25
Expected recruitment end date
2016-11-05, 1395/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intravitreal adalimumab injection on pseudophakic macular edema
Public title
The effect of intravitreal adalimumab injection on pseudophakic macular edema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with pseudophakic macular edema and PCIOL in bag who have received prior treatment (topical NSAIDs or topical corticosteroids). Exclusion criteria: patients with macular edema due to causes other than pseudophakia(diabetes, uveitis, retinitis pigmentosa); complicated surgery (vitrous loss); PCIOL in sulcus and ACIOL.
Age
From 40 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
5
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
Shiraz Univercity of Medical Sciences
Street address
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, Iran
City
Shiraz
Postal code
Approval date
2013-10-10, 1392/07/18
Ethics committee reference number
92-01-01-6327
Health conditions studied
1
Description of health condition studied
Pseudophakic macular edema
ICD-10 code
H35.8
ICD-10 code description
Other specified retinal disorders
Primary outcomes
1
Description
Visual acuity
Timepoint
Before injection, 1 week and 1 month after injection
Method of measurement
Snellen chart
Secondary outcomes
1
Description
Central macular thickness
Timepoint
Before injection, 1 week and 1 month after injection
Method of measurement
OCT
Intervention groups
1
Description
intravitreal adalimumab injection
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalili hospital
Full name of responsible person
Doctor Mohsen Farvardin
Street address
Iran
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Sayed Basir Hashemi
Street address
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, Iran
City
Shiraz
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, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Doctor Mohsen Farvardin
Position
posterior segment fellowship
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz,
City
Shiraz
Postal code
Phone
+98 71 3230 5410
Fax
Email
farvardm@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Doctor Mohsen Farvardin
Position
posterior segment fellowship
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz,
City
Shiraz
Postal code
Phone
+98 71 3230 5410
Fax
Email
farvardm@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Doctor Mohsen Farvardin
Position
posterior segment fellowship
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz,
City
Shiraz
Postal code
Phone
+98 71 3230 5410
Fax
Email
farvardm@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)