Intralesional administration of interferon alfa 2-b in treatment of pterygium
Design
A randomized, single blinded, clinical trial with a parallel group design of 60 patients, enrolled between February 2020 and February 2021
Settings and conduct
The current study is a single blinded clinical trial conducted at Al-Zahra Hospital in Zahedan. Patients with pterygium with at least 1 mm of corneal involvement will be included in the study. Patients will be divided into each of the study groups based on the block randomization method. in 30 patients,In intervention group, We will inject interferon alfa-2b in the pterygium base near the Limbus area and in 30 other patients(Control group), sterile physiological saline solution will be administered as placebo.
In all cases, chloramphenicol 0.5% will be administered 4 times in first 24 hours after beginning of treatment.
Patients will be examined again after 48 hours, one week, and then monthly for 6 months after injection, and will be evaluated by pterygium size, conjunctivitis, and photophobia.
Participants/Inclusion and exclusion criteria
Patients referring to Al-Zahra Ophthalmology hospital in Zahedan
Inclusion criteria:
Patients with pure Pterygium that involve at least 1mm of cornea based on clinical diagnosis
Exclusion criteria:
Any eye pathology other than pterygium
Intervention groups
Patients will be divided into two groups randomly, in Intervention group 0.1 ml interferon α-2b (IFN-α-2b) will be injected in the pterygium base. then chloramphenicol will be administered QID in first 24 hours after beginning of treatment.
In Control group 0.1 ml Sterile Physiological Serum will be injected in the pterygium base. then chloramphenicol 0.5% will be administered QID in first 24 hours after beginning of treatment.
Main outcome variables
Pterygium size؛ Photophobia؛ Pterygium Hyperemia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120817010617N5
Registration date:2020-04-14, 1399/01/26
Registration timing:registered_while_recruiting
Last update:2020-04-14, 1399/01/26
Update count:0
Registration date
2020-04-14, 1399/01/26
Registrant information
Name
morteza Sedaghat Kia
Name of organization / entity
zaums
Country
Iran (Islamic Republic of)
Phone
+98 54 1244 9540
Email address
morimedico@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-04-19, 1399/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intralesional administration of interferon alfa 2-b in treatment of pterygium
Public title
Effect of administration of interferon alfa 2-b in treatment of pterygium
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with pure Pterygium that involve at least 1mm cornea based on clinical diagnosis
Exclusion criteria:
Any eye pathology other than pterygium
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with blocks of 10. Considering the sample size of 60, 6 blocks will be selected; in each block there will be equal numbers of cards for each group. By selecting each block, 10 patients in each group will be selected.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients will be randomly assigned to one of the two groups receiving interferon α-2b or Sterile Physiological Serum. The administration of medication or serum is the same in both groups, and patients will be unaware of the group assignment. therefore this study will be a single blinded clinical trial study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Dr.Hesabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2018-09-23, 1397/07/01
Ethics committee reference number
Ir.ZAUMS.REC.1398.447
Health conditions studied
1
Description of health condition studied
pterygium of eye
ICD-10 code
H11.0
ICD-10 code description
Pterygium of eye
Primary outcomes
1
Description
Pterygium size
Timepoint
Patients will be examined after 48 hours, one week, and then monthly for 6 months after injection.
Method of measurement
Based on slit lamp examination
2
Description
Photophobia
Timepoint
Patients will be examined after 48 hours, one week, and then monthly for 6 months after injection.
Method of measurement
Based on slit lamp examination
3
Description
Pterygium Hyperemia
Timepoint
Patients will be examined after 48 hours, one week, and then monthly for 6 months after injection.
Method of measurement
slit lamp examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 0.1 ml interferon α-2b (IFN-α-2b) IntronA, Schering Plough, Kenilworth, NJ1 million units/mL) will be injected in the pterygium base near the Limbus area. then chloramphenicol 0.5% will be administered QID in first 24 hours after beginning of treatment.
Category
Treatment - Drugs
2
Description
Control group: 0.1 ml Sterile Physiological Serum will be injected in the pterygium base near the Limbus area. then chloramphenicol 0.5% will be administered QID in first 24 hours after beginning of treatment.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Eye hospital
Full name of responsible person
Meisam Sargazi
Street address
Shahid Motahar Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737789
Phone
+98 54 3321 9915
Email
Meisam.sargazi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Nour Mohammad Bakhshani
Street address
Dr Hesabi Sq.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Email
zaums.research@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Meisam Sargazi
Position
Ophthalmology resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Shahid Motahar Blvd, Al-Zahra Eye hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737789
Phone
+98 54 3329 5796
Email
Meisam.sargazi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Arish
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Motahari Blvd. Alzahra eye hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737789
Phone
+98 54 3321 9915
Email
Arish.mohammed@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Meisam Sargazi
Position
Ophthalmology resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Motahari Blvd. Alzahra eye hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737789
Phone
+98 54 3321 9915
Email
Meisam.sargazi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available