Comparison complication of Hydroxyapatite and Medpor ocular implant insersion after enucleation in Ahwaz imam hospital (from jan 2010 to jun 2011) . All patients over 18 months (from jan 2010 until June 2011) in Ahvaz Imam Khomeini Hospital who have loss of vision for different reasons have been under surgery to enucleation with the implant insersion. exclusion criteria :eye lid disorders such as entropion;triciasis; ectropion ; cul-de-sac problems before surgery ;anophthalmus;conjunctiveal ;eyelid malignancies.in a clinical trial study 50 patients that had indication for enucleation randomly divided in two groups of 25 patients group 1 under went enucleation + hydroxyapatite (HA) and group 2 underwent enucleation + medpor implant, all patients were operated by 2 surgeons then were followed for 6 months and complications were compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205139729N1
Registration date:2012-06-25, 1391/04/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-06-25, 1391/04/05
Registrant information
Name
Safar Mohamadzadeh
Name of organization / entity
Ahwaz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 914 462 0271
Email address
mohamadzadeh.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz University of Medical Sciences
Expected recruitment start date
2011-01-21, 1389/11/01
Expected recruitment end date
2011-07-21, 1390/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison complication Of Hydroxyapatite and Medpor Ocular Implant Insersion After Enucleation In Ahwaz Imam Hospital (from jan 2010 to jun2011)
Public title
Comparison Complication Of Hydroxyapatite and Medpor Ocular Implant Insersion.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Loss of vision ;Enuclation with the implant insersion.
Exclusion criteria :Eye lid disorders such as Entropion;Triciasis; Ectropion ; cul-de-sac problems before surgery ;Anophthalmus;Conjunctiveal ; Eyelid malignancies
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahwaz University of Medical Science .
Street address
Ahwaz Univercity of Medical Science ، University town ، Ahwaz
City
Ahwaz
Postal code
61357-15794
Approval date
2009-07-15, 1388/04/24
Ethics committee reference number
1912//20/8/پ
Health conditions studied
1
Description of health condition studied
Comparison complication of two method of eye enuclation and implant insersion
ICD-10 code
H53-H54
ICD-10 code description
Visual disturbances and blindness
Primary outcomes
1
Description
Mucupurulent discharge
Timepoint
10,30,90,180
Method of measurement
Examination with slitlamp
Secondary outcomes
1
Description
granulom tissue
Timepoint
10th,30th,90th,180th day
Method of measurement
Examination with slit lamp
2
Description
conjunctival cyst
Timepoint
10th,30th,90th,180th day
Method of measurement
Examination with slit lamp
3
Description
cul-de- sac limitation
Timepoint
10th,30th,90th,180th day
Method of measurement
Examination with slit lamp
4
Description
Range of eye movements
Timepoint
10th,30th,90th,180th day
Method of measurement
Examination with slit lamp
5
Description
Implant expuser
Timepoint
10th,30th,90th,180th day
Method of measurement
Examination with slit lamp
6
Description
Eyelid edema
Timepoint
10th,30th,90th,180th day
Method of measurement
Examination with slit lamp
7
Description
cunjuctival chemosis
Timepoint
10th,30th,90th,180th day
Method of measurement
Examination with slit lamp
Intervention groups
1
Description
surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hospital
Full name of responsible person
Street address
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice Chancellar of Ahwaz University of Medical Sciense
Full name of responsible person
Mostafa Feghi
Street address
Ahwaz University of Medical Sciences ، University Town ، Ahwaz
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice Chancellar of Ahwaz University of Medical Sciense
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
Ahwaz University of Medical Sciences
Full name of responsible person
Ghaderpanah Mahboobe
Position
Associated Professor
Other areas of specialty/work
Street address
Imam Hospital, Azadegan Avenue.
City
Ahwaz
Postal code
Phone
+98 611222114
Fax
Email
ghaderpanah_m58@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz University of Medical Sciences
Full name of responsible person
Ghaderpanah Mahboobe
Position
Associated professor
Other areas of specialty/work
Street address
Iimam Hospital,Azadegan Avenue
City
Ahwaz
Postal code
Phone
+98 61 1222 2114
Fax
Email
ghaderpanah_m58@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahwaz University of Medical Sciences
Full name of responsible person
Mohamadzadeh Safar
Position
Other areas of specialty/work
Street address
Imam Hospital, Azadegan Avenue.
City
Ahwaz
Postal code
Phone
Fax
mohamadzadeh.s@ajums.ac.ir
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)