Aim: The purpose of the study is to determine whether amniotic membrane can be used as an alternative to conjunctival autograft after pterygium excision.
Design: Randomized clinical trial.
Methods: seventy eyes with either primary or recurrent pterygium are included in this study. All eyes are randomized to undergo conjunctival autograft or amniotic membrane transplantation after pterygium excision by a single surgeon. Twenty seven eyes with primary and 8 eyes with recurrent pterygium will be treated with conjunctival autograft, and 26 eyes with primary and 9 eyes with recurrent pterygium will be treated with amniotic membrane transplantation. Patients are followed up at one week, one month and three months after operation. The main outcome measurement is recurrence rate after surgery. The patients with inadequate follow up are excluded from the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013100114697N1
Registration date:2013-10-05, 1392/07/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-10-05, 1392/07/13
Registrant information
Name
Mehdi Alizadeh
Name of organization / entity
Hamadan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0572
Email address
m.alizadeh@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Science
Expected recruitment start date
2013-10-23, 1392/08/01
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of conjunctival autografts and amniotic membrane grafts for treatment of ptrygium.
Public title
Comparison of conjunctival autografts and amniotic membrane grafts for treatment of pterygium.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients with primary or recurrent pterygium.
Exclusion criteria: Patients with inadequate follow up after surgery.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Block Randomization.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Science
Street address
Shahid Fahmideh Street, Hamadan
City
Hamadan
Postal code
6541844886
Approval date
2013-09-10, 1392/06/19
Ethics committee reference number
1688/9/35/16/پ/د
Health conditions studied
1
Description of health condition studied
Pterygium
ICD-10 code
H11.0
ICD-10 code description
Pterygium
Primary outcomes
1
Description
Recurrence
Timepoint
One week, one month and three months post op.
Method of measurement
Slit lamp
2
Description
Inflamation
Timepoint
One week, one month and three months post op.
Method of measurement
Slit lamp
Secondary outcomes
1
Description
Refraction
Timepoint
Pre operation and one week, one month and three months post op.
Method of measurement
Refractometer
Intervention groups
1
Description
Intervention: Amniotic Membrane Transplantation
(Amniotic membrane is separated from its carrier paper under a microscope and is expanded on denuded area in order to cover the bare sclera.)
Category
Treatment - Surgery
2
Description
Control: Conjunctival Autograft Transplantation
(Conjunctival graft is removed from the superior region of the sick eye and is expanded on denuded area in order to cover the bare sclera.)
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital of Hamadan
Full name of responsible person
Mehdi Alizadeh-Nasrin Mohebi
Street address
Mirzadeh Eshghi Street, Hamadan
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Hamadan University of Medical Science
Full name of responsible person
Yosef Alikhani
Street address
Shahid Fahmideh Street, Hamadan
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Hamadan University of Medical Science
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
Hamadan University of Medical Science
Full name of responsible person
Mehdi Alizadeh
Position
Assistant professor
Other areas of specialty/work
Street address
Shahid Fahmideh Street, Hamadan
City
Hamadan
Postal code
6541844886
Phone
+98 81 1838 0574
Fax
+98 81 1838 0208
Email
m.alizadeh@umsha.ac.ir; nasrin_mohebi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Science
Full name of responsible person
Mehdi Alizadeh
Position
Ophtalmologist
Other areas of specialty/work
Street address
Shahid Fahmideh Street, Hamadan
City
Hamadan
Postal code
6541844886
Phone
+98 81 1838 0574
Fax
+98 81 1838 0208
Email
m.alizadeh@umsha.ac.ir; nasrin_mohebi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of M edical Science
Full name of responsible person
Mehdi Alizadeh
Position
Ophtalmologist
Other areas of specialty/work
Street address
Shahid Fahmideh Street, Hamadan
City
Hamadan
Postal code
6541844886
Phone
+98 81 1838 0574
Fax
+98 81 1838 0208
Email
m.alizadeh@umsha.ac.ir; nasrin_mohebi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)