Randomised, Single Blind, Controlled, Three-Month Clinical Trial on the Evaluation and Treatment of the Ocular Surface Damage Following Phacoemulsification

Abstract

Background: To determine efficacy of two lacrimal substitutes on signs and symptoms of ocular surface disease after phacoemulsification; to determine impact of surgery on patients’ vision related quality of life. Monocentric, randomised, physician blinded, three parallel groups clinical trial. Design and Methods: Patients in the operative list for phacoemulsification have been screened for eligibility; they underwent (at time 0, 15, 45 and 90 days): slit lamp examination; tear film break-up time (BUT); corneal staining; tear volume; 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ); Ocular Surface Disease Index (OSDI). Treatments to be compared were: 1. standard of care-SOC (lomefloxacine and tobramicine/dexamethasone fixed combination 4 times a day for 2 weeks), 2. SOC + carboxymethylcellulose sodium 0.5% and glycerin 0.9%, 3. SOC + Sodium Hyaluronate 0.15%. Study treatment started at T15. Groups were compared with parametric or nonparametric tests, and with Pearson’s χ2 test. Correlation between continuous variables was assessed by means of Pearson’s or Spearman’s coefficient. Results: Fifty-three patients were enrolled. At 45 and at 90 days from surgery, the group receiving lacrimal substitutes presented better BUT and Schirmer I test (p = 0.009, <0.001, <0.001 and 0.001, respectively); dry eye presence showed significant difference by group at time 90 (p = 0.019). General vision, near activity and vision-specific dependency subscales improved after surgery (p = <0.001, 0.004 and 0.048, respectively). At 45 and 90 days from surgery, the OSDI score significantly changed (p < 0.001).Conclusions: Cataract surgery causes the onset or the worsening of dry eye. Use of artificial tears can significantly reduce symptoms and signs of dry eye in patients after phacoemulsification.