Abstract:AIM: To investigate botulinum toxin A (BTXA) efficacy on small-angle (≤25Δ) acute acquired concomitant esotropia (AACE) in early-stage patients. METHODS: The electronic medical record data of AACE patients during March 2019 and June 2023 were collected in this retrospective and hospital-based cohort study. A total of 72 small-angle AACE patients received BTXA extraocular muscle injection. Patients were grouped by onset-to-treatment time (Group A: ≤6mo, Group B: >6mo). Deviation of esotropia, eye alignment and stereopsis were analyzed at the period of pre/post-injection (1wk, 1, 3, and 6mo). Orthophoria rate at 6mo (horizontal deviation <10Δ and binocular single vision) were considered as outcome index. RESULTS: There were no significant baseline differences (P>0.05) between two groups except onset-to-treatment time (2mo vs 11mo, P<0.001). Higher orthophoria rates were in Group A at last follow-up (94.74% vs 73.53%, P=0.013). Post-BTXA deviations of two groups at 1mo showed no difference (P>0.05); while in 3 and 6mo Group A was significantly smaller than group B (all P<0.001). No statistically significant differences were observed among all post-BTXA deviations of near and distance in Group A. In Group B, deviation at 3mo (near: 2Δ vs 0, P<0.001; distance: 4Δ vs 0, P<0.001) and 6mo (near: 6Δ vs 0, P<0.001; distance: 6Δ vs 0, P<0.001) was significant increased compared to deviation at 1wk after treatment. Group A showed better stereopsis recovery in last follow-up compared to Group B (80’’ vs 200’’, P=0.002). Both groups obtained improved stereopsis after treatment (Group A: 80’’ vs 300’’, P<0.001; Group B: 200’’ vs 300’’, P=0.037). CONCLUSION: BTXA is effective for AACE with small deviation (≤25Δ) in early stage. Delayed treatment (>6mo) may reduce BTXA efficacy. Early BTXA intervention benefits long-term eye alignment and stereopsis recovery.