Analysis of the application effect of an automated eye position fixation training device in patients undergoing pterygium surgery: a two-year follow-up randomized controlled trial.

OBJECTIVE

This study aimed to evaluate the long-term effects of an automated eye position fixation training device (AEPFTD) on intraoperative cooperation, surgical efficiency, complications, and recurrence rates in patients undergoing pterygium surgery.

METHODS

In this single-center, double-blinded, prospective randomized controlled trial, 114 patients scheduled for unilateral primary pterygium surgery participated. Participants were randomly assigned to receive preoperative training using either the AEPFTD (experimental group, EG) or conventional manual training (control group, CG). We assessed primary outcomes of intraoperative cooperation in eye position, total operative time, and sustained maintenance of eye position. For secondary outcomes, we monitored recurrence rates at 6, 12, and 24 months after surgery, as well as specific intraoperative complications, including conjunctival suture loosening, corneal abrasion, and conjunctival tear. We analyzed outcomes with complete data using standard between-group statistical tests. For the recurrence, we also performed a per-protocol analysis and multiple imputation to handle missing follow-up data.

RESULTS

The EG had a significantly shorter total operative time than the CG (44.01 ± 4.96 min vs. 46.41 ± 4.73 min, p = 0.009). Adjustment counts for intraoperative eye position control showed no significant difference between groups (3 (1, 6) vs. 3 (1, 6) times, p = 0.734). Both groups showed comparable sustained eye-position maintenance (140.7 [105.3, 325.4] s vs. 144.1 [93.9, 281.8] s, p = 0.973). Both groups showed no significant differences in specific complications (conjunctival suture loosening, corneal abrasion, or conjunctival tear; all p > 0.05) or in the overall complication rate (10.53% vs. 17.54%, p = 0.236). In the PPS analysis, recurrence rates at 6 months, 1 year, and 2 years did not differ significantly. After we used MI to handle missing follow-up data, logistic regression also showed no significant difference in the 2-year recurrence rate (OR = 1.294, 95% CI: 0.295-5.683, p = 0.734).

CONCLUSION

Compared with conventional manual training, the AEPFTD reduced operative time without significant differences in intraoperative cooperation, complications, or recurrence.