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IRCT20160919029871N6 IRCT 2023-02-12 Guilan University of Medical Sciences Comparison of recurrence and complications of pterygium surgery in patients underwent pterygium surgery Comparison of recurrence and complications of pterygium surgery in the inferior rotational conjunctival autograft compared with the superior rotational conjunctival autograft in patients underwent pterygium surgery -a randomized clinical trial 2023-02-20 anticipated 80 Complete https://irct.ir/trial/68132 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: If the patients meet the inclusion criteria, they will be randomly assigned to two groups A (patients who will undergo inferior rotational conjunctival autograft) and group B (patients who will undergo surgery using superior rotational conjunctival autograft) based on random blocks. Patients will be randomly divided into 2 groups with quadruple blocks of 40 people and will be examined in a single-blind manner. Registration of participants and allocation to groups will be done by the resident.The block sequence list is kept in a sealed and sealed letter in the Ophthalmology Research Center, and after the research permission from the Ethics Committee, the envelope is opened at the beginning of the study and based on gradual referrals, the patients will be placed in A or B groups, Blinding description: Being placed in group A or B and the type of surgery with lower conjunctival autograft or upper conjunctival autograft will not be told to the patient.(The patient will not know how to be selected in the treatment groups). N/A Pterygium. Intervention 1: Intervention group: groups A (patients who will undergo inferior rotational conjunctival autograft) Best corrected visual acuity, clinical inflammation of the pterygium surgery site, the duration of corneal epithelial defect repair, the occurrence of possible complications of pterygium surgery on the 1st, 3rd, 7th and 30th days after the operation and the recurrence of the lesion during the 6-month follow-up are checked by slit lamp. 6 months of follow-up are recorded and compared in two groups. The day after surgery, group A will be treated with topical antibiotic drugs (Chloramphenicol0.5%) and topical steroid Betamethasone 0.1%) with a dose of four times a day. The dose is reduced for two months and then stopped. Intervention 2: Control group: group B (patients who will undergo surgery using superior rotational conjunctival autograft) Best corrected visual acuity, clinical inflammation of the pterygium surgery site, the duration of corneal epithelial defect repair, the occurrence of possible complications of pterygium surgery on the 1st, 3rd, 7th and 30th days after the operation and the recurrence of the lesion during the 6-month follow-up are checked by slit lamp. 6 months of follow-up are recorded and compared in two groups.The day after surgery, group A will be treated with topical antibiotic drugs (Chloramphenicol0.5%) and topical steroid Betamethasone 0.1%) with a dose of four times a day. The dose is reduced for two months and then stopped. 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 It is not yet known if there will be a plan to make this available
public Dr Mitra Akbari
Eye Research Center, Amiralmomenin Hospital, 17 Shahrivar St, Rasht
Rasht Iran (Islamic Republic of) 41396-37459 +98 13 3323 6886 mitra.akbari20@gmail.com Guilan University of Medical Sciences scientific Dr Mitra Akbari
Eye Research Center, Amiralmomenin Hospital, 17 Shahrivar St, Rasht
Rasht Iran (Islamic Republic of) 41396-37459 +98 31 3323 6886 mitra.akbari20@gmail.com Guilan University of Medical Sciences Iran (Islamic Republic of) Patients with a Pterygium larger than 3 mm at horizontal width over the cornea on Slit-lamp exam who are candidates for surgery no limit no limit Both Patients with previous pterygium recurrence The size of the base of the pterygium in the limbus region is greater than 8 mm Pregnant and breastfeeding patients Patients suffering from systemic diseases such as diabetes Patients with eye surface diseases such as keratitis, conjunctivitis and severe dry eyes Patients with a background of eye surgery in the last 6 months H11.0 Pterygium of eye Treatment - Surgery Treatment - Surgery Intervention group: groups A (patients who will undergo inferior rotational conjunctival autograft) Best corrected visual acuity, clinical inflammation of the pterygium surgery site, the duration of corneal epithelial defect repair, the occurrence of possible complications of pterygium surgery on the 1st, 3rd, 7th and 30th days after the operation and the recurrence of the lesion during the 6-month follow-up are checked by slit lamp. 6 months of follow-up are recorded and compared in two groups. The day after surgery, group A will be treated with topical antibiotic drugs (Chloramphenicol0.5%) and topical steroid Betamethasone 0.1%) with a dose of four times a day. The dose is reduced for two months and then stopped. Control group: group B (patients who will undergo surgery using superior rotational conjunctival autograft) Best corrected visual acuity, clinical inflammation of the pterygium surgery site, the duration of corneal epithelial defect repair, the occurrence of possible complications of pterygium surgery on the 1st, 3rd, 7th and 30th days after the operation and the recurrence of the lesion during the 6-month follow-up are checked by slit lamp. 6 months of follow-up are recorded and compared in two groups.The day after surgery, group A will be treated with topical antibiotic drugs (Chloramphenicol0.5%) and topical steroid Betamethasone 0.1%) with a dose of four times a day. The dose is reduced for two months and then stopped. Pterygium Recurrence. Timepoint: 6 Months After Surgery. Method of measurement: Clinical Examination. Best Corrected Visual Acuity. Timepoint: Day 1, 3, 7, 30 After Surgery. Method of measurement: Clinical Examination. Clinical Inflammation Grading At Operation Site. Timepoint: Day 1, 3, 7, 30 After Surgery. Method of measurement: Clinical Examination. Epithelial Defect Healing Time. Timepoint: Day 1, 3, 7, 30 After Surgery. Method of measurement: Clinical Examination. Possible Complication of Pterygium Surgery. Timepoint: Day 1, 3, 7, 30 After Surgery. Method of measurement: Clinical Examination. Guilan University of Medical Sciences Approved 2022-11-23 Ethics Committee of Guilan University of Medical Sciences Shahid Siadaty St., Namju St., Rasht Rasht Guilan Iran (Islamic Republic of)