Comparison of the effect of interferon alfa 2 b (IFN-α2b) drops with mitomycin c during surgery on pterygium recurrence in pterygium surgery by Rotational conjunctival autograft method
To determine the impact of topical interferon alfa2b drops on inflammation, recurrence and complications of pterygium surgery
Design
Patients with a Pterygium larger than 3 mm at horizontal width on the cornea on Slit-lamp exam candidates for surgery.Patients are included are assigned randomly into 2 groups.One group receiving topical drops of corticosteroids, antibiotic and interferon alfa2b and the other receiving topical drops of corticosteroids and antibiotic and mitomycin during surgery. On post operative day 1, 3, 7, 30, 90 and 6 months after surgery patients corrected visual acuity, clinical inflammation grading, time for epithelial defect to repair and complications of surgery and recurrence of pteygium will be examined and compared in these groups
Settings and conduct
The study will be conducted in the eye clinic of Amiralmomenin hospital. The study will be single-blind and patients will not be informed of the addition of interferon alfa2b drop
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with a Pterygium larger than 3 mm at horizontal width over the cornea on Slit-lamp exam who are candidates for surgery. Non-Inclusion criteria:patients with previous pterygium recurrence; pseudo-pterygium; pregnant and breastfeeding mothers; systemic disease like diabetes and heart disease; ocular surface disease like keratitis or dry eye or conjunctivitis; prior ocular surgery within 6 months; hypersensitivity to interferon alfa2b
Intervention groups
Patients who were included were assigned randomly through block randomization using blocks of size 4. Group A: Patients receiving topical drops of corticosteroids, antibiotic and interferon alfa2b(without received mitomycin during surgery). Group B: Patients receiving topical drops of corticosteroids and antibiotic and mitomycin during surgery.
Main outcome variables
Clinical inflammation grading and pterygium recurrence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160919029871N5
Registration date:2021-12-26, 1400/10/05
Registration timing:registered_while_recruiting
Last update:2021-12-26, 1400/10/05
Update count:0
Registration date
2021-12-26, 1400/10/05
Registrant information
Name
Mita Akbari
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3323 6886
Email address
mitra.akbari@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of interferon alfa 2 b (IFN-α2b) drops with mitomycin c during surgery on pterygium recurrence in pterygium surgery by Rotational conjunctival autograft method
Public title
Comparison of the effect of interferon alfa 2 b (IFN-α2b) drops with mitomycin c during surgery on pterygium recurrence in pterygium surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a Pterygium larger than 3 mm at horizontal width over the cornea on Slit-lamp exam who are candidates for surgery
Exclusion criteria:
Patients with previous pterygium recurrence, pseudo- Pterygium، Pregnant and breastfeeding mothers, systemic disease like diabetes and heart disease Ocular surface disease like keratitis or dry eye or conjunctivitis،Prior ocular surgery within 6 months Hypersensitivity to interferon alfa 2 b.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with random allocation software version 2 based on quadruple random blocks (with a choice of 15 quadruple random blocks), into two groups A (patients who, in addition to receiving corticosteroid and antibiotics, eye drops) They will also receive alpha interferon 2b, but without the use of mitomycin during surgery) and group B (patients who receive only eye drops of corticosteroids and antibiotics and mitomycin during surgery) will be randomly substituted. The list of block sequences is kept in a sealed letter at the Ophthalmology Research Center, and after permission from the ethics committee to conduct the study, the envelope is opened at the beginning of the study and patients are placed in group A or B based on gradual referrals.
Blinding (investigator's opinion)
Single blinded
Blinding description
The addition of interferon alfa 2 b drop is not explained to the patients
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی گیلان
Street address
Shahid Siadaty St., Namju St., Rasht
City
Rasht
Province
Guilan
Postal code
41446-66949
Approval date
2021-11-24, 1400/09/03
Ethics committee reference number
IR.GUMS.REC.1400.411
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
Clinical inflammation grading and pterygium recurrence
Timepoint
Day 1, 3, 7, 30, 90 and 6 months after surgery
Method of measurement
Clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: Aside from the topical Bethamethasone and Antibiotic drops the intervention group will receive topical drops of interferon alfa 2 b (IFN-α2b) drops for 3 months.
Category
Treatment - Drugs
2
Description
Control group: Control group: Patients receiving topical Corticosteroids and Antibiotic drops and mitomycin during surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Mitra Akbari
Street address
Eye Research Center, Amiralmomenin Hospital,17 Shahrivar St,Rasht
City
Rasht
Province
Guilan
Postal code
41396-37459
Phone
+98 13 3323 6886
Email
mitra.akbari20@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammad Reza Naghipour
Street address
Shahid Siadaty St, Namju St, Rasht
City
Rasht
Province
Guilan
Postal code
41446-66949
Phone
+98 13 3333 0862
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Dr Mitra Akbari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Eye Research Center, Amiralmomenin Hospital, 17 Shahrivar St,Rasht
City
Rasht
Province
Guilan
Postal code
41396-37459
Phone
+98 13 3323 6886
Email
mitra.akbari20@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Mitra Akbari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Eye Research Center, Amiralmomenin Hospital, 17 Shahrivar St, Rasht
City
Rasht
Province
Guilan
Postal code
41396-37459
Phone
+98 13 3323 6886
Email
mitra.akbari20@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Shila Kianmehr
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Health Service Management
Street address
Eye Research Center, Amiralmomenin Hospital, 17 Shahrivar St, Rasht
City
Rasht
Province
Guilan
Postal code
41396-37459
Phone
+98 13 3323 6886
Email
shila.kianmehr@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