]>
IRCT20220215054028N1 IRCT 2022-05-17 Mashhad University of Medical Sciences A comparative study of recurrence rate and complications between mitomycin c, interferone alpha 2b and bevasizumab after primary pterygium surgery A comparative study of recurrence rate and complications between mitomycin c, interferone alpha 2b and bevasizumab after primary pterygium surgery 2022-05-20 anticipated 63 Complete https://irct.ir/trial/61995 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 2-3 Primary pterygium. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. Undecided - It is not yet known if there will be a plan to make this available
public Solmaz Momtahan ghalati
No 3, Kolahdouz 44, Kolahdouz avenu, Mashhad town
Mashhad Iran (Islamic Republic of) 9184975997 +98 938 094 6737 momtahens981@mums.ac.ir Mashhad University of Medical Sciences scientific Solmaz Momtahan ghalati
No 3, Kolahdouz 44, Kolahdouz avenu, Mashhad town
Mashhad Iran (Islamic Republic of) 9184975997 +98 938 094 6737 momtahens981@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 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 40 years 60 years Both Patients with recurrent pterygium Patients with no tendency for pterygium surgery Patients with active ophthalmic infection H11.0 Pterygium of eye Treatment - Drugs Treatment - Drugs Treatment - Drugs 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. 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. 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. 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. 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. Mashhad University of Medical Sciences Approved 2022-02-14 Ethics committee of Mashhad University of Medical Sciences Education department, Khatam-al-anbia Hospital, Gharani 41, Gharani Blvd. Mashhad Razavi Khorasan Iran (Islamic Republic of)