The study will be conducted on 90 patients with grade II-IV acute ocular chemical burns (Roper - Hall classification) in the first 2 weeks of injury to evaluate the role of amniotic membrane transplantation in ocular chemical burns.
After topical anesthesia, all patients initially will receive first aid therapy; which included irrigation with normal saline to normalize ocular surface PH and removal of early particulate maeuil and debris. After complete examination and obtaining informed consent, the patients will be randomized using a treatment assignment list to either amniotic membrane transplantation with conventional medical therapy (group A) or medical treatment only (group B). In the patients with bilateral injuries the eyes will be randomized separately. Amniotic membrane transplantation will be performed within 24h of presentation. The patients will be examined at days 1, 3, 7, 10, 14, 21, 28 and then biweekly until 3 months and monthly until (1 year in every visit), visual acuity will be checked (by sneillen charts).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904071180N16
Registration date:2010-06-28, 1389/04/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-06-28, 1389/04/07
Registrant information
Name
pooya rostami
Name of organization / entity
Opthalmic Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 2258 5952
Email address
labbafi@hotmail.com
Recruitment status
Recruitment complete
Funding source
Ophthalmic Research Center
Expected recruitment start date
2006-07-12, 1385/04/21
Expected recruitment end date
2006-11-12, 1385/08/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Role of Amniotic Membrane Transplantation in Ocular Chemical Burns
Public title
The Role of Amniotic Membrane Transplantation in Ocular Chemical Burns
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients with chemical eye burn grade 2-4, Burning has been occurred during 2 weeks ago. Exclusion Criteria: Grade I burnings, Follow up of the patients has been disconnected in 6 month.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
ClinicalTrials.gov
Secondary trial Id
NCT00370812
Registration date
2008-09-23, 1387/07/02
Ethics committees
1
Ethics committee
Name of ethics committee
Ophthalmic Research Center
Street address
No 23, Pasdaran Ave, 9th Boostan, Ophthalmic Research Center
City
Tehran
Postal code
166666
Approval date
2006-07-26, 1385/05/04
Ethics committee reference number
ت چ،5220
Health conditions studied
1
Description of health condition studied
Eye burn
ICD-10 code
T26
ICD-10 code description
Burn and corrosion confined to eye and adnexa
Primary outcomes
1
Description
Visual acuity
Timepoint
Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year
Method of measurement
snellen chart
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: amniotic membrane transplantation with conventional medical therapy
Category
Other
2
Description
Control: Medical treatment alone
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Labbafinejad Hospital
Full name of responsible person
Alireza Baradaran Raffiee, MD
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ophthalmic Research Center
Full name of responsible person
Ali-asghar Aghdai
Street address
No 23, Pasdaran Ave, 9th Boostan, Ophthalmic Rsearch Center
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ophthalmic Research Center
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
Ophthalmic Rsearch Center
Full name of responsible person
Dr Alireza Baradaran Rafee
Position
Ophthalmologist
Other areas of specialty/work
Street address
No 23, Pasdaran Ave, 9 th Boostan, Ophthalmic Research Center
City
Ttehran
Postal code
166666
Phone
+98 21 2259 2200
Fax
Email
labbafi@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Baradaran Rafiee, MD
Position
Ophthalmolgist
Other areas of specialty/work
Street address
N0 23, Pasdaran Ave, 9th Boostan, Ophthalmic Research Center
City
Tehran
Postal code
1666663111
Phone
+98 21 2276 6106
Fax
Email
labbafi@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Pooya Rostami
Position
General physician
Other areas of specialty/work
Street address
No 23, Pasdaran Ave, 9th Boostan, Ophthalmic Research Center
City
Tehran
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)