Comparative study of intraoperative injection of bevasizumab and interferone alpha 2b and topical application of mitomycin c , on post-operative complications and recurrence rate after primary pterygium surgery
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2-3 on 63 patients. PASS statistical software was used for randomization.
Settings and conduct
The study is performed in Khatam-al-anbia hospital in Mashhad. Patients are divided into 3 groups of 21 people. In all groups, the pterygium and subconjunctival tenon are removed and the drug is used and then conjunctival autograft is performed by the senior assistant.
The subjects and evaluators are concealed in this study. concealing is done by closed envelopes.
Participants/Inclusion and exclusion criteria
Inclusion criteria are the following: presence of primary pterygium at least 1 mm in size; decreased vision due to the pterygium; existence of a cylinder due to the pterygium; the patient's desire to undergo pterygium surgery; no history of pterygium surgery (primary pterygium); no history of allergy to interferon alfa 2b.
exclusion criteria: active ophthalmic infection; recurrent pterygium
Intervention groups
In this study, pterygium resection is performed and for one group intraconjunctival injection of bevacizumab is given, for the second group mitomycin c is used topically during surgery and for the other group interferon alfa 2b is injected intraconjunctivally.
Main outcome variables
The recurrence rate of pterygium after primary pterygium surgery; incidence of complications after primary pterygium surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220215054028N1
Registration date:2022-05-17, 1401/02/27
Registration timing:prospective
Last update:2022-05-17, 1401/02/27
Update count:0
Registration date
2022-05-17, 1401/02/27
Registrant information
Name
Solmaz Momtahan ghalati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 938 094 6737
Email address
momtahens981@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-20, 1401/02/30
Expected recruitment end date
2022-07-01, 1401/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of recurrence rate and complications between mitomycin c, interferone alpha 2b and bevasizumab after primary pterygium surgery
Public title
A comparative study of recurrence rate and complications between mitomycin c, interferone alpha 2b and bevasizumab after primary pterygium surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Existence of primary pterygium at least 1 mm in size
Decrease in visual acuity due to pterygium
The patient's tendency for pterygium surgery
Having no history of previous pterygium surgery
Having no history of allergy to interferone alpha 2 B
Cylinder caused by pterygium
Exclusion criteria:
Patients with recurrent pterygium
Patients with no tendency for pterygium surgery
Patients with active ophthalmic infection
Age
From 40 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
63
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed using statistical software PASS. To do so, the study groups (coded) and the number of patients in each group will be entered into the software and a random sequence of the patients will be generated.
The sequences will be inserted into some thick envelopes in the same order as they were generated by a person who is not aware of the study so that the contents of the envelopes are not visible. Then, an envelope (in the order of the sequence generated) will be opened for each patient admitted to the study and the patient will be grouped into one of the three study groups based on the content of the envelope. All steps of sequencing and the process of grouping the patients will be done by someone who is not aware of the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
The sequences will be inserted into some thick envelopes in the same order as they were generated by a person who is not aware of the study so that the contents of the envelopes are not visible. Then, an envelope (in the order of the sequence generated) will be opened for each patient admitted to the study and the patient will be grouped into one of the three study groups based on the content of the envelope. All steps of sequencing and the process of grouping the patients will be done by someone who is not aware of the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Pterygium recurrence rate after primary pterygium surgery
Timepoint
At the beginning of the study, after 48 hours, one week, one month, 6 months and then 1 year after the operation
Method of measurement
Slit lamp
2
Description
Complication rate after primary pterygium surgery
Timepoint
At the beginning of the study, after 48 hours, one week, one month, 6 months and then 1 year after the operation
Method of measurement
Slit lamp
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: after pterygium removal, 1.25 mg bevacizumab is injected into the recipient conjunctiva 5 mm far from the free edge of the recipient area in the superior, inferior and nasal areas, and then free conjunctival autograft is performed.
Category
Treatment - Drugs
2
Description
Intervention group: after removing the pterygium, 3 million units of interferon alfa 2b is injected into the recipient conjunctiva at 5 mm far from the free edge of the graft receptor area in the superior, inferior and nasal areas, and then free conjunctival autograft is performed.
Category
Treatment - Drugs
3
Description
Intervention group: after removal of the pterygium, the area under the pterygium is covered with a sponge soaked in mitomycin c for 90 seconds, then washed and a free conjunctival autograft is performed.
Vice Chancellor for Research and Technology, third floor, University of Medical Sciences, next to Hoveyzeh Cinema, University Street, Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Fax
+98 51 3843 0249
Email
GhayourM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Solmaz Momtahan ghalati
Position
Resident of ophthalmology
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
No 3, Kolahdouz 44, Kolahdouz avenu, Mashhad town
City
Mashhad
Province
Razavi Khorasan
Postal code
9184975997
Phone
+98 938 094 6737
Fax
Email
momtahens981@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Solmaz Momtahan ghalati
Position
Resident of ophthalmology
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
No 3, Kolahdouz 44, Kolahdouz avenu, Mashhad town
City
Mashhad
Province
Razavi Khorasan
Postal code
9184975997
Phone
+98 938 094 6737
Fax
Email
momtahens981@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Solmaz Momtahan ghalati
Position
Resident of ophthalmology
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
No 3, Kolahdouz 44, Kolahdouz avenu, Mashhad town
City
Mashhad
Province
Razavi Khorasan
Postal code
9184975997
Phone
+98 938 094 6737
Fax
Email
momtahens981@mums.ac.ir
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