The purpose of this study was to assess the response rate to intravitreal injection of Triamcinolone in cases of RP with CME. In this study, the patients with a definitive diagnosis of RP were assessed and those with a central foveal thickness less than 250 microns (according to OCT), and a history of glaucoma or cataract surgery were excluded. The sample was 87 patients with RP, among which, those with CME were selected and enrolled after they signed written informed consents. BCVA, fluorescein angiography, OCT, and autofluorescence were conducted at different time intervals after intravitreal injection of 4mg Triamcinolon, and results were compared to draw conclusions. The primary outcome measure was changes in visual acuity (BCVA) and the secondary outcome measure was the central foveal thickness as measured with OCT, and comparing the pre- to post-injection values.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104266293N1
Registration date:2011-06-24, 1390/04/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-24, 1390/04/03
Registrant information
Name
Mohammad Riazi Esfahani
Name of organization / entity
Eye Research Center, Farabi Eye Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 8865 1515
Email address
mriazi@noorvision.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2007-09-23, 1386/07/01
Expected recruitment end date
2008-04-19, 1387/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intravitreal Injection of Triamcinolone Acetonide in Retinitis Pigmentosa with cystoids macular edema
Public title
Intravitreal Injection of Triamcinolone Acetonide in Retinitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of RP based on paraclinic tests
Exclusion criteria: one-eyed patients, history of glaucoma, any opacity in media and history of intraocular surgery
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
161
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
Tehran University Eye Research Center
Street address
Tehran, Farabi eye hospital
City
Tehran
Postal code
Approval date
2011-05-23, 1390/03/02
Ethics committee reference number
ERC/s/903
Health conditions studied
1
Description of health condition studied
cystoids macular edema (CME) secondary to retinitis pigmentosa (RP)
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
visual acuity
Timepoint
3 weeks, 3 months and 6 months after the injection
Method of measurement
snellen chart
Secondary outcomes
1
Description
macular thickness and angiographic changes
Timepoint
3 weeks, 3 and 6 months after the injection
Method of measurement
Slit lamp examination, fundoscopy and OCT
Intervention groups
1
Description
Intravitreal injection of 4mg Triamcinolon in 0.1cc were done only once using a 29 gauge needle at 3.5mm posterior to the limbus. Complete eye examinations including best corrected visual acuity (BCVA) tests, photography with autofluorescence, fluorescein angiography, and OCT is done before the injection and at 1 month, 3 months, and 6 months after injection. Results were then was compared. In cases of bilateral CME, only one eye was selected for injection.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi Eye Hospital, Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Riazi Esfahani
Street address
Farabi eye hospital, Qazvin Sq., South Kargar St, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Alireza Lashay
Street address
Farabi eye hospital, Qazvin Sq., South Kargar St, Tehran, Iran
City
Tehran
Grant name
ندارد
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
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
vice-chancellor of Farabi eye hospital, TUMS
Full name of responsible person
Dr Mohammad Riazi Esfahani
Position
fellowship-Associate Professor
Other areas of specialty/work
Street address
Farabi eye hospital, Qazvin Sq., South Kargar St, Tehran, Iran
City
Tehran
Postal code
Phone
+98 215540000314
Fax
+98 21 5541 8080
Email
Info@farabihospital.com
Web page address
www.farabihospiatl.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Farabi Eye Hospital, Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Riazi Esfahani
Position
associated professor
Other areas of specialty/work
Street address
Farabi eye hospital, Qazvin Sq., South Kargar St, Tehran, Iran
City
Tehran
Postal code
Phone
+98 215540000413
Fax
+98 21 5541 8080
Email
mriazi@noorvision.com;mriazi@sina.tums.ac.ir
Web page address
www.farabihospital.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Riazi Esfahani
Position
Associate Professor
Other areas of specialty/work
Street address
Farabi eye hospital, Qazvin Sq., South Kargar St, Tehran, Iran
City
Tehran
Postal code
Phone
+98 215540000314
Fax
+98 21 5541 8080
Email
Info@farabihospital.com
Web page address
www.farabihospital.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)