Randomized Controlled Trial Comparing Everting Sutures with a Lateral Tarsal Strip for Involutional Lower Eyelid Entropion.

INTRODUCTION

To compare the anatomical and functional outcome and changes in the quality of life (QoL) over time of the lateral tarsal strip (LTS) versus the Quickert everting sutures (ES) for the repair of primary involutional lower eyelid entropion.

METHODS

Forty-five patients (54 eyes) with primary involutional lower eyelid entropion were recruited in a prospective randomized clinical trial over 3-year period. Twenty-six eyes were randomized to the LTS technique and 28 to the ES procedure. Primary outcome was the anatomical correction of the eyelid at the final assessment in 1 year. Secondary outcomes were function and symptoms assessment with a QoL questionnaire at 6 months. Fisher's exact test was used for the statistical analysis of success rate and gender study and Mann-Whitney U test and logistic regression analysis were used for age study. The Wilcoxon and Mann-Whitney U tests were used for the analysis of the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25).

RESULTS

At the 6-month follow-up, 25 eyes (96.2%) of the LTS group and 20 (71.4%) of the ES group had favorable outcome (P = 0.025). There were one and eight eyes, respectively, with early recurrence. At the final 12-month evaluation, 23 eyes (88.5%) in the LTS group and 16 eyes (57.1%) in the ES group were successful. Three (11.5%) and 12 (42.9%) eyes respectively showed postoperative recurrence. There was a statistically significant difference between the two groups (P = 0.015) for the primary outcome, whereas age and gender did not influence success. The NEI VFQ-25 showed statistically significant subjective improvement from baseline in most categories of the QoL. No significant difference between the two procedures was detected at 6 months.

CONCLUSION

This study suggests that the LTS procedure has a superior surgical success rate and reduction of symptoms compared with the ES for the repair of involutional lower eyelid entropion. Both procedures showed similar improvement of the postoperative QoL.

TRIAL REGISTRATION

International Clinical Trials Registry Platform identifier: ACTRN12616000620426.