Protocol summary

Summary
This study is a randomized, non-blinded, placebo-controlled single-center trial .All patients with non-proliferative diabetic retinopathy entry criteria with clinically significant macular edema and retinal referred to Imam Khomeini hospital of Ahwaz..patients with History of previous treatment for clinical significant macular edema such macular laser and intra viterus avastin injection ;Posterior segment truma ;The need for subsequent surgery of the eye, such as cataract surgery or vitreoretinal ;Clinical evaluation is not possible or where 0CT or FA Like intense opacity media; despite previous pathology such as retinal vascular occlusion, AMD...; History of previous intraocular surgery; Patients with visual acuity less than 1/10 were to study included. In this study 40 patients referred to the eye clinic of Ahvaz Imam Khomeini hospital with non-proliferative diabetic retinopathy and clinically significant macular edema were excluded and Fluorescein angiography to examine retinal leak fluid ; Coherence optical tomography(OCT) is performed to determine the thickness of the retina.The visual acuity and intraocular pressure were measured.Patients with status of macular edema treatmented with macular photocoagulation(MPC) or intravitreal Avastin injection and then were randomized two groups;A group of 20 patients received three Doxium capsuls daily and the second group 20 patients received placebo capsules daily for three months ; after three months evaluated of retinal thickness ;visual acuity and intraocular pressure in both groups are compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012091610852N1
Registration date: 2013-04-21, 1392/02/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-04-21, 1392/02/01
Registrant information
Name
Akbar Takhtaeayan
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1448 2187
Email address
mfeghhi@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2012-07-22, 1391/05/01
Expected recruitment end date
2013-01-19, 1391/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral calcium dobisulate (doxium) on macular thickness in diabetic retinopathy and clinicaly significant macular edema(CSME)
Public title
The effect of doxium on retial thickness in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : All patients with non prolifrative diabetic retinopathy and clinical significant macular edema refered to retinal clinic emam khomini hospital ,, ***Exclusion critreria ::History of previous treatment for clinical significant macular edema such macular laser and intra viterus avastin injection ;Posterior segment trauma ;The need for subsequent surgery of the eye, such as cataract surgery or vitreoretinal ;Clinical evaluation is not possible or where 0CT or FA Like intense opacity media; despite previous pathology such as retinal vascular occlusion, AMD...; History of previous intraocular surgery; Patients with visual acuity less than 1/10
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz bolvar Golestan
City
Ahvaz
Postal code
15794-61357
Approval date
2012-05-19, 1391/02/30
Ethics committee reference number
ETH-469

Health conditions studied

1

Description of health condition studied
Diabets melitus
ICD-10 code
H36
ICD-10 code description
Diabetic retinopathy

Primary outcomes

1

Description
macular thickness
Timepoint
befor and 3 month of treatment
Method of measurement
OCT

Secondary outcomes

1

Description
visual acuity
Timepoint
before and 3 month after treatment
Method of measurement
snelen chart

2

Description
intra ocular pressure
Timepoint
before and 3 month after treatment
Method of measurement
goldman tonometry

Intervention groups

1

Description
calcium dobisulate (doxium) capsules 500 mg,oraly , three times in one day for three months
Category
Treatment - Drugs

2

Description
Placebo capsules, orally ,three times daily for three months.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam khomini hospital of ahvaz
Full name of responsible person
Akbar takhtaeayan
Street address
Street, 24 meters Ahvaz Imam Khomeini hospital
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mostafa Feghhi
Street address
Ahvaz bolvar daneshgah
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Akbar Takhtaeayan
Position
ophthalmology resident
Other areas of specialty/work
Street address
Ahvaz bolvare daneshgah
City
Ahvaz
Postal code
15794-61357
Phone
+98 61 1373 8383
Fax
Email
akbart79@yahoo.com
Web page address
ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Akbar Takhtaeayan
Position
ophthalmology resident
Other areas of specialty/work
Street address
Ahvaz bolvar daneshgah
City
Ahvaz
Postal code
Phone
+98 61 1373 8383
Fax
Email
akbart79@yahoo.com
Web page address
ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Akbar Takhtaeayan
Position
ophthalmology resident
Other areas of specialty/work
Street address
Ahvaz bolvare daneshgah
City
Ahvaz
Postal code
15794-61357
Phone
+98 61 1222 8076
Fax
Email
akbart79@yahoo.com
Web page address
ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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