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IRCT20201120049450N1 IRCT 2021-12-27 Shiraz University of Medical Sciences Combined laser and bevacizumab in ROP treatment Comparing the effect of near confluent laser versus combination of less dense laser and bevacizumab on prethreshold Retinopathy of prematurity (ROP) type 1 zone 2: Randomized clinical trial 2021-11-04 anticipated 43 Complete https://irct.ir/trial/54176 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients included in the study were divided into patient and control groups based on a random number table. The table of random numbers starts from number 1 and is in the form of sequences that for example put number 1 as A and number 2 as A, number 3 to number 8 as B and ... This is a global standard table where group A can be considered a case and group B can be considered a control, Blinding description: Ophthalmologist team (those who exam and follow the neonates) are unaware of the group of patients. 1-2 Retinopathy of prematurity. Intervention 1: Intervention group: combined less dense laser and intravitreal Bevacizumab(dosage: 0.625micro). This combination treatment is performed in Khalili's operating room with prior reservation from the NICU. The next day after the operation, the baby is examined and then weekly for up to 4 weeks and the last examination after 24 weeks. At each stage, the stage of the disease is measured, and in case of regression of the stage and reduction of abnormal arteries, no new intervention is needed. Intervention 2: Control group: dense laser treatment. This treatment is performed in Khalili's operating room with prior reservation from the NICU. The next day after the operation, the baby is examined and then weekly for up to 4 weeks and the last examination after 24 weeks. At each stage, the stage of the disease is measured, and in case of regression of the stage and reduction of abnormal arteries, no new intervention is needed. Yes - There is a plan to make this available What will be shared: Outcomes of near confluent laser versus combined less dense laser and bevacizumab treatment of prethreshold ROP type 1 zone 2: Randomized clinical trial When: 2021 To whom: people working in academic institutions Conditions: If poostchi-eye research center permitted Where to obtain: poostchi-eye research center How to obtain: request from poostchi-eye research center Comments:
public Ehsan Namvar
Poostchi eye clinic, Poostchi street
Shiraz Iran (Islamic Republic of) 7193616641 +98 71 3629 1779 Namvar.e@gmail.com Shiraz University of Medical Sciences scientific Ehsan Namvar
Poostchi eye clinic, Poostchi street
Shiraz Iran (Islamic Republic of) 7193616641 +98 71 3230 2830 Namvar.e@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Retinopathy of prematurity Type 1 prethreshold location: Zone 2 of retina (from posterior circle to nasal ora serrata) 1 month 4 months Both elavated demarcation ridge vitreous hemorrhage threshold zone 1 neovascularization of iris H35.109 Retinopathy of prematurity, unspecified, unspecified eye Treatment - Drugs Treatment - Other Intervention group: combined less dense laser and intravitreal Bevacizumab(dosage: 0.625micro). This combination treatment is performed in Khalili's operating room with prior reservation from the NICU. The next day after the operation, the baby is examined and then weekly for up to 4 weeks and the last examination after 24 weeks. At each stage, the stage of the disease is measured, and in case of regression of the stage and reduction of abnormal arteries, no new intervention is needed. Control group: dense laser treatment. This treatment is performed in Khalili's operating room with prior reservation from the NICU. The next day after the operation, the baby is examined and then weekly for up to 4 weeks and the last examination after 24 weeks. At each stage, the stage of the disease is measured, and in case of regression of the stage and reduction of abnormal arteries, no new intervention is needed. Regression and progression of vascularization. Timepoint: Monthly up to 6 months. Method of measurement: Fundus examination. Shiraz University of Medical Sciences Approved 2021-11-04 Ethics committee of Shiraz University of Medical Sciences Poostchi street, Poostchi eye clinic Shiraz Fars Iran (Islamic Republic of)