BACKGROUND: To investigate the efficacy and safety of subconjunctival bevacizumab application as an adjuvant therapy for primary pterygium. DESIGN: This study was a clinical randomized trial performed at the Institute of Ophthalmology 'Conde de Valenciana'. PARTICIPANTS: Forty-nine patients with primary pterygium were enrolled in the study. METHODS: Each primary pterygium patient was randomized after pterygium excision and a conjunctival autograft to receive either a single 2.5 mg/0.1 mL dose of subconjunctival bevacizumab immediately after surgery (group 1); a double 2.5 mg/0.1 mL injection of subconjunctival bevacizumab, one immediately after surgery and the second 15 days after surgery (group 2); or no injection (group 3). MAIN OUTCOME MEASURES: Autoconjunctival graft presence or absence of ischaemia, necrosis, infection or detachment; surgical bed appearance; and pterygium recurrence at 1-year follow-up period were determined. RESULTS:Forty-nine eyes of 49 patients were included. Sixteen patients were assigned to group 1, 17 to group 2 and 16 to group 3. Patients from groups 1 and 2 showed conjunctival autograft ischaemia at 24 h postoperative (37.5% and 58.8%, respectively, P > 0.05), which disappeared by the first postoperative month. No significant difference in the main outcome measures was found among single versus double-dose of subconjunctival bevacizumab injection patients. At the end of the study, pterygium recurrences were observed only in group 3 (P < 0.04). CONCLUSIONS: A single 2.5 mg/mL subconjunctival bevacizumab injection in conjunction with primary pterygium surgery accomplishing a conjunctival autograft procedure is safe and well tolerated, and is capable of preventing pterygium recurrences when compared with a control group.
RCT Entities:
BACKGROUND: To investigate the efficacy and safety of subconjunctival bevacizumab application as an adjuvant therapy for primary pterygium. DESIGN: This study was a clinical randomized trial performed at the Institute of Ophthalmology 'Conde de Valenciana'. PARTICIPANTS: Forty-nine patients with primary pterygium were enrolled in the study. METHODS: Each primary pterygium patient was randomized after pterygium excision and a conjunctival autograft to receive either a single 2.5 mg/0.1 mL dose of subconjunctival bevacizumab immediately after surgery (group 1); a double 2.5 mg/0.1 mL injection of subconjunctival bevacizumab, one immediately after surgery and the second 15 days after surgery (group 2); or no injection (group 3). MAIN OUTCOME MEASURES: Autoconjunctival graft presence or absence of ischaemia, necrosis, infection or detachment; surgical bed appearance; and pterygium recurrence at 1-year follow-up period were determined. RESULTS: Forty-nine eyes of 49 patients were included. Sixteen patients were assigned to group 1, 17 to group 2 and 16 to group 3. Patients from groups 1 and 2 showed conjunctival autograft ischaemia at 24 h postoperative (37.5% and 58.8%, respectively, P > 0.05), which disappeared by the first postoperative month. No significant difference in the main outcome measures was found among single versus double-dose of subconjunctival bevacizumab injection patients. At the end of the study, pterygium recurrences were observed only in group 3 (P < 0.04). CONCLUSIONS: A single 2.5 mg/mL subconjunctival bevacizumab injection in conjunction with primary pterygium surgery accomplishing a conjunctival autograft procedure is safe and well tolerated, and is capable of preventing pterygium recurrences when compared with a control group.