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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: IRCT
Last refreshed on: 22 February 2018
Main ID:  IRCT2016100430130N1
Date of registration: 2016-12-03
Prospective Registration: No
Primary sponsor: Vice chancellor for research, Shiraz University of Medical Sciences
Public title: The effect of intravitreal adalimumab injection on pseudophakic macular edema
Scientific title: The effect of intravitreal adalimumab injection on pseudophakic macular edema
Date of first enrolment: 2016-10-16
Target sample size: 5
Recruitment status: Complete
URL:  http://en.irct.ir/trial/24038
Study type:  interventional
Study design:  Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.  
Phase:  N/A
Countries of recruitment
Iran (Islamic Republic of)
Contacts
Name: Doctor Mohsen Farvardin   
Address:  Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, Shiraz Iran (Islamic Republic of)
Telephone: +98 71 3230 5410
Email: farvardm@sums.ac.ir
Affiliation:  Shiraz University of Medical Sciences
Name: Doctor Mohsen Farvardin   
Address:  Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, Shiraz Iran (Islamic Republic of)
Telephone: +98 71 3230 5410
Email: farvardm@sums.ac.ir
Affiliation:  Shiraz University of Medical Sciences
Key inclusion & exclusion criteria
Inclusion 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.
Exclusion criteria:

Age minimum: 40 years
Age maximum: 85 years
Gender: Both
Health Condition(s) or Problem(s) studied
Pseudophakic macular edema.
Other specified retinal disorders
Other specified retinal disorders
Intervention(s)
Treatment - Drugs
intravitreal adalimumab injection
intravitreal adalimumab injection.
Primary Outcome(s)
Visual acuity. Timepoint: Before injection, 1 week and 1 month after injection. Method of measurement: Snellen chart.
Secondary Outcome(s)
Central macular thickness. Timepoint: Before injection, 1 week and 1 month after injection. Method of measurement: OCT.
Secondary ID(s)
Source(s) of Monetary Support
Vice chancellor for research, Shiraz University of Medical Sciences
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Shiraz Univercity of Medical Sciences
Results
Results available:
Date Posted:
Date Completed:
URL:
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