Comparison of two techniques of pterygium surgery, Rotational autograft from pterygium tissue versus free conjunctival graft in patients suufering from pterigyum: a clinical trial
The aim of this study was to evaluate the rate of recurrence in two methods of the pterygium surgery. This was a randomized, single blind, single-centered study. 45 patients suffering from pterygium referred to the Shiraz Khalili Hospital entered into intervention and control groups respectively. The inclusion criteria were: the presence of primary pterygium with surgical indications and age younger than 55. The exclusion criteria of the study include: the pterygiums being suspicious of conjunctival intraepithelial neoplasia, the presence of symblepharon, recrudescent pterygiums, double head pterygium, pseudopterygia, having any history of eye disease. In both groups, pterygium was treated by surgery in combination with interaoperative mitomycin C. In the intervention group pterygium tissue and in the control group supra temporal conjunctiva was used as the transplantation tissue. Patients were evaluated for recurrence and other complications such as hyperemia and appearance of the eye after surgery (main outcomes).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016092119581N2
Registration date:2017-11-04, 1396/08/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-11-04, 1396/08/13
Registrant information
Name
Shahram Bamdad
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 2830
Email address
shahrambamdad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2014-01-13, 1392/10/23
Expected recruitment end date
2014-07-17, 1393/04/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two techniques of pterygium surgery, Rotational autograft from pterygium tissue versus free conjunctival graft in patients suufering from pterigyum: a clinical trial
Public title
Comparison of two techniques of pterygium surgery: graft from pterygium tissue versus free conjunctival graft
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria were: the presence of primary pterygium (temporal or nasal), having surgical indications (vision deterioration as a result of the involvement of visual axis and inducing irregular astigmatism, chronic eye irritation, recrudescent inflammation, limitation of eye movement, cosmetic problems, and more than 2 mm growth on the cornea), and the patient who were younger than 55. Primary pterygium is defined as having no history of pterygium surgery for the target eye.
Exclusion criteria: the pterygiums being suspicious of conjunctival intraepithelial neoplasia; the presence of symblepharon; recrudescent pterygiums; double head pterygium; pseudopterygia; having a history of eye trauma and corneal scar.
Age
From 19 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
according to the visit patients with the odd numbers were puted in the intervention group and with the number of couples in the control group
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, Iran
City
Shiraz
Postal code
7134814336
Approval date
2015-08-05, 1394/05/14
Ethics committee reference number
IR.SUMS.med.REC.1394.43
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
6 Months after the intervention.
Method of measurement
Slit lamp
Secondary outcomes
1
Description
graft injection
Timepoint
6 Months after the intervention.
Method of measurement
with slit lamp
2
Description
cosmesis
Timepoint
6 Months after the intervention.
Method of measurement
with slit lamp
Intervention groups
1
Description
Intervention group: Pterygium surgery
by using
pteygium as transplanted tissue. In this method after pterygium removal, the fibrovascular tssue was removed from the pterygium and with 180 degree rotation was sutured to place. Except for the surgical procedure, all follow-up procedures were the same in two methods.
Category
Treatment - Surgery
2
Description
control group: pterygium surgery with free graft, In this method, after the removal of the pterygium, the supra temporal conjunctiva was used as graft. the patients were followed for 6 months.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalili Hospital
Full name of responsible person
Doctor Shahram Bamdad
Street address
Khalili Hospital, Khalili Street, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Doctor Sayed Basir Hashemi
Street address
The headquarters of the Palestinian street Shyrazrvbrvy University of Medical Sciences, Zand Street, Shiraz,
City
Shiraz
Grant name
پابان نامه دانشجویی
Grant code / Reference number
93-01-01-8901
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Doctor Shahram Bamdad
Position
Assistant Professor, Department of Ophthalmology
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, Iran
City
Shiraz
Postal code
7134814336
Phone
+98 71 3230 5410
Fax
+98 71 3233 7598
Email
Shahrambamdad@yahoo.com
Web page address
Psorc.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Doctor Shahram Bamdad
Position
Fellowship of anterior segment and and ocular surface disease
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, Iran
City
Shiraz
Postal code
7134997446
Phone
+98 71 3230 5410
Fax
+98 71 3233 7598
Email
Shahrambamdad@yahoo.com
Web page address
Psorc.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Doctor Shahram Bamdad
Position
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, Iran
City
Shiraz
Postal code
7134814336
Phone
+98 71 3230 5410
Fax
+98 71 3233 7598
Email
Shahrambamdad@yahoo.com
Web page address
Psorc.sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)