A randomized comparative trial of safety and efficacy of topical vitamin A and carboxymethylcellulose 1% on symptoms of dry eye disease after cataract surgery

Abstract

Background: The objective of the study was to evaluate the efficacy and safety of topical vitamin A and carboxymethylcellulose (CMC) 1% in reducing dry eye symptoms after phacoemulsification cataract surgery. Material and methods: A prospective interventional randomized comparative open-labeled study was conducted during which all patients undergoing phacoemulsification for age-related cataracts were included. The 270 patients were equally and randomly divided into the three groups A–C of 90 patients each: Group A — patients treated with CMC 1%, Group B — patients treated with retinyl palmitate (vitamin A), and Group C — patients with only conventional post-operative topical therapy. The outcome measures were changes in visual acuity, Schirmer test results, tear break-up time, mean goblet cell density (MGCD), and ocular symptoms in terms of Ocular Surface Disease Index (OSDI) at follow-up of 1 month. Any side effects due to interventions were also noted in the follow-up period. Results: On day 30 th , the final Schirmer test results (mean ± SD) were significantly higher in Group B than in Group A, and controls (12.3 ± 2.23 vs. 11.2 ± 3.11 vs. 9.25 ± 2.51; p < .0001); the final tear film break-up time was significantly longer in Group B than in Group A and controls (12.86 ± 2.56 vs. 11.16 ± 2.67 vs. 9.67 ± 2.86; p < .0001); there was an increase in the MGCD (mean ± SD) in all the three groups with the values being significantly higher in Group B vs. Group A vs. controls (309.07 ± 20.26 vs. 295.18 ± 22.96 vs. 277.84 ± 20.86, p < .0001) and the final OSDI scores were significantly lower in Group B than in Group A, and controls (33.42 ± 1.79 vs. 34.46 ± 2.29 vs. 39.83 ± 1.72, p < .0001). Adverse effects were as follows: foreign body sensation, red-eye, and eye swelling, which were similar among the study groups (p > 0.05). Conclusion: We conclude that the use of topical vitamin A on the corneal surface post-cataract surgery reduces the symptoms of dry eyes much faster than 1% CMC or conventional treatment. However, all three interventions carried a similar profile of side effects.