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IRCT20120817010617N5 IRCT 2020-04-14 Zahedan University of Medical Sciences Effect of administration of interferon alfa 2-b in treatment of pterygium Intralesional administration of interferon alfa 2-b in treatment of pterygium 2020-01-21 anticipated 60 Complete https://irct.ir/trial/44709 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 pterygium of eye. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is not decided
public Meisam Sargazi
Shahid Motahar Blvd, Al-Zahra Eye hospital
Zahedan Iran (Islamic Republic of) 9816737789 +98 54 3329 5796 Meisam.sargazi@gmail.com Zahedan University of Medical Sciences scientific Dr. Mohammad Arish
Motahari Blvd. Alzahra eye hospital
Zahedan Iran (Islamic Republic of) 9816737789 +98 54 3321 9915 Arish.mohammed@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) patients with pure Pterygium that involve at least 1mm cornea based on clinical diagnosis no limit no limit Both Any eye pathology other than pterygium H11.0 Pterygium of eye Treatment - Drugs Placebo 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. 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. 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. 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. 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. Zahedan University of Medical Sciences Approved 2018-09-23 Ethics Committee of Zahedan University of Medical Sciences Dr.Hesabi Square Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)