Protocol summary

Study aim
The efficacy of topical interferon alpha-2b in primary and recurrent pterygium
Design
The data collection tool was a two-part questionnaire. The first part contains patient’s identification and demographic information. The second part of questionnaire contains history and ophthalmic examination. Ophthalmic examination(keratometery, size, grade, BCVA, UCVA, refraction) was done for all patients 4 times: before the first subconjunctival injection, the end of first month, third month, sixth month.
Settings and conduct
The study were performed on patients with Pterygium attending to Ophthalmology clinic of Baqiyatallah hospital, Tehran, Iran; whose disease has been confirmed by an ophthalmologist. Patients were subconjunctivalally injected with interferon alpha-2b with 3million / ml every one month for two occasions. At the same time, a topical drop of interferon alpha-2b with a concentration of 1 million unit / ml for patients was initiated. The duration of use of this drop was three months, with the first month every 6 hours, the second month every 8 hours, and the third month every 12 hours.
Participants/Inclusion and exclusion criteria
The inclusion criteria were defined as: Any patients with primary pterygium; either unilaterally or bilaterally, who diagnosed by an ophthalmologist. Exclusion criteria: -Use of any local ophthalmic drug -Patients with History of Refractive Surgery -History of any eye diseases other than refractive disorders -Pregnant or lactating women
Intervention groups
Subconjunctival injections of 3 million/ml Interferon alpha-2b was done for all patients two times: the first injection was done in the first day and second injection was performed at the end of first month. IFNα2b. Also IFNα2b 1 million/ml Topical eye-drops was given to all patients for three month.
Main outcome variables
The efficacy of topical interferon alpha-2b in primary and recurrent pterygium

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190806044463N1
Registration date: 2019-12-09, 1398/09/18
Registration timing: retrospective

Last update: 2019-12-09, 1398/09/18
Update count: 0
Registration date
2019-12-09, 1398/09/18
Registrant information
Name
Ahmad zarei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4254 0608
Email address
ahmadzarei1373@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-09-01, 1395/06/11
Expected recruitment end date
2018-02-01, 1396/11/12
Actual recruitment start date
2016-09-01, 1395/06/11
Actual recruitment end date
2018-02-01, 1396/11/12
Trial completion date
2018-06-01, 1397/03/11
Scientific title
The efficacy of topical interferon alpha-2b in primary and recurrent pterygium
Public title
The efficacy of topical interferon alpha-2b in pterygium
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Any patients with primary or recurrent pterygium; either unilaterally or bilaterally, who was diagnosed by an ophthalmologist
Exclusion criteria:
Use of any topical ophthalmic drug in previous six months Patients with allergy to interferon alpha-2b Patients with History of Refractive Surgery History of any eye diseases other than refractive errors and pterygium Pregnant or lactating women
Age
From 19 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 18
Actual sample size reached: 18
More than 1 sample in each individual
Actual sample size in each individual: 2
18 eyes (16 patients)
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of baqiyatallah University of Medical Sciences
Street address
Iranshahr Ave., opposite Artists' Park - Mofatteh Dormitory - Room 400
City
tehran
Province
Tehran
Postal code
1583737811
Approval date
2017-12-11, 1396/09/20
Ethics committee reference number
Ir.bmsu.rec.1396.471 این کد در سال 1396 اخذ شده است و به همین دلیل است که در سامانه ملی اخلاق در پژوهش های زیست پزشکی به آدرس ethics.research.ac.ir موجود نیست. تصویر گواهی تاییدیه اخلاق به همراه شماره ترایال به آدرس ایمیل admin@irct.ir

Health conditions studied

1

Description of health condition studied
pterygium
ICD-10 code
H11.0
ICD-10 code description
Pterygium of eye

Primary outcomes

1

Description
pterygium grade
Timepoint
1- Baseline (before injection) 2- 1st month 2- 2nd month 3- 6th month
Method of measurement
Based on the degree of visibility of the epithelial vessels by an ophthalmologist

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: interferon alpha 2b (In this study, there was only one intervention group: There was no control group in this study: Comparison between pre and post intervention was performed in the same group.)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah Ophthalmology Clinic
Full name of responsible person
Esmaeil Shabaninezhad
Street address
Mulla Sadra Street, Sheikh Bahai Intersection, Baqiyatallah Clinic
City
tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0435
Email
ahmadzarei1373@gmail.com
Web page address
https://baq.bmsu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
gholamhossein alishiri
Street address
Mulla Sadra Street, Sheikh Bahai Intersection, Baqiyatallah university of medical science
City
tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 3131
Email
ahmadzarei1373@gmail.com
Web page address
https://www.bmsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Esmaeil Shabaninezhad
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Iranshahr Ave., opposite Artists' Park - Mofatteh Dormitory - Room 400
City
tehran
Province
Tehran
Postal code
1583737811
Phone
+98 21 8248 3614
Email
shabaninjad@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Esmaeil Shabaninezhad
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Iranshahr Ave., opposite Artists' Park - Mofatteh Dormitory - Room 400
City
tehran
Province
Tehran
Postal code
1583737811
Phone
+98 21 8248 3614
Email
shabaninjad@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Esmaeil Shabaninezhad
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Iranshahr Ave., opposite Artists' Park - Mofatteh Dormitory - Room 400
City
Tehran
Province
Tehran
Postal code
1583737811
Phone
+98 21 8248 3614
Email
shabaninjad@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
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
Loading...