Abstract
BACKGROUND: Recent artificial tear preparations have provided 0.2% concentration of sodium hyaluronate. However, no published data exist on their potential superiority against 0.1% in alleviating dry-eye-disease symptoms in cataract extraction surgery. METHODS: A total of 180 patients that underwent cataract extraction surgery were randomly divided into 2 groups according to their postoperative regime: Study group (SG) received fixed combination of tobramycin and dexamethasone (FCTD) quid for 3 weeks, and additionally 0.2% sodium hyaluronate provided in the COMOD® device quid for 6 weeks. Control group (CG) received fixed combination of tobramycin and dexamethasone (FCTD) quid for 3 weeks, and additionally 0.1% sodium hyaluronate provided in the COMOD® device quid for 6 weeks. The following indexes were evaluated at 3 postoperative checkpoints: 1) Surface discomfort index (SDI) which was derived by four direct 10-scale Likert-type questions that were addressed to the patient and pertained to: a) foreign body sensation (FBS), b) blinking discomfort (BD), c) stinging sensation (SS), d) tearing sensation (TS), 2) Tear break-up time (TBUT), 3) Schirmer's test, 4) Central corneal thickness (CCT), and 4) Central Corneal Sensitivity (CCS). RESULTS: Both groups showed reduced CCS values at all postoperative examination points; however, SG participants had significantly better CCS (all p < 0.05). SG had better TBUT than CG at the 3rd (p = 0.03) and 6th examination points (p = 0.04). Moreover, SG had better SDI scores at the 3rd (SDI = 9.26 ± 0.55) and 6th weeks (SDI = 9.47 ± 0.48) vs. CG participants (p = 0.03 and p < 0.01, respectively). CONCLUSION: The increased 0.2% sodium hyaluronate concentration in the artificial tears provided in the COMOD® device seems to address dry-eye-disease symptoms better in patients who underwent phacoemulsification surgery than the 0.1% concentration. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03705949 Oct 15, 2018, retrospectively registered.