Outcomes of near confluent laser versus combined less dense laser and bevacizumab treatment of prethreshold ROP Type 1 Zone 2: a randomized controlled trial

BACKGROUND: To evaluate the results of near confluent laser therapy versus combined less dense laser and intra vitreal bevacizumab in treatment of infants with type 1 retinopathy of prematurity (ROP) in zone II. METHODS: This is a prospective double-blinded randomized clinical trial study. Infants with Type 1 ROP in Zone 2 were randomized into case and control groups. Conventional laser therapy was executed for control group and combination of IVB and laser treatment was employed for the case group. RESULTS: Eighty-six eyes from 43 infants were analyzed in this trial. The first group included 42 eyes from 21 infants receiving a combination of laser ablation and IVB. The second group contained 44 eyes from 22 infants who received only conventional laser therapy. The combined IVB and laser ablation group demonstrated the neovascularization regression (20 out of 21 infants) one week after the procedure. In the conventional laser therapy group, this regression was found in (12 out of 22 infants) within one week after laser therapy (P = 0.001). Plus disease regression was observed in 20 (20/21) of combined treatment group and 7 infants (7/22) of conventional laser treatment group after one week. CONCLUSION: Combined less dense laser and bevacizumab treatment resulted in more rapid regression in comparison with the conventional laser treatment. TRIAL REGISTRATION: IRCT20201120049450N1, 27/12/2021.