All participants underwent a routine ophthalmological examination i.e., measurement of best-corrected visual acuity (BCVA) by means of Snellen charts, slit lamp examination, intraocular pressure measurement by Goldmann applanation tonometry and fundoscopy in addition to a complete medical history. Patient information included age, sex, educational and marital status, number of offspring and siblings, alcohol consumption, income, expenses, exercise, current smoking and presence of diabetes mellitus. Cataract was classified as: immature (partially opaque lens, disc view hazy), mature (completely opaque lens, no disc view), hypermature (liquefied cortical matter), Morganian. Exclusion criteria were the following: (1) history of intraocular surgery in the operated eye, (2) any previous episode of uveitis in the operated eye, (3) severe systemic disease (heart failure NYHA stage III of IV, end-stage renal failure, pulmonary failure, patients receiving chemotherapy), (4) regular, systemic use of steroid or non-steroidal anti-inflammatory drugs during the last three months, (5) uncontrolled glaucoma.
On the day of surgery, the pupil was dilated with tropicamide 0.5% (Tropixal, Demo) and phenylephrine hydrochloride 5% (Phenylephrine, Cooper) drops every 10 for 30 min before surgery. Phacoemulsification was performed using Alcon Series 20000® Legacy® by the same surgeon (LP).
Patients were randomized to one of the two postoperative treatment arms: (1) tobramycin 0.3%–dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day (TD group, n = 72) and (2) combination of tobramycin 0.3%–dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day, plus ketorolac tromethamine 0.5% (Acular®, Allergan), one drop three times/day (TD-K group, n = 73). The topical treatment was administered for 28 days after phacoemulsification. The study was masked to patients, i.e., patients received unmarked bottles so as to be unaware of which treatment they received. Patients who needed additional pupil devices for inadequate dilation or those whose underwent vitrectomy due to posterior capsule rupture (PCR) were excluded; as a result, 68 patients were ultimately included in the TD group and 70 patients in the TD-K group, as shown in the respective flowchart  (Fig. 1).
All patients completed the VFQ-25 in order to assess their functional vision before cataract surgery and postoperatively on day 7, 28 and 42. The VFQ-25 measures the following vision-dependent sub-scales: general health (GH), general vision (GV), ocular pain (OP), near activities (NA), distance activities (DA), social functioning (VSSF), mental health (VSMH), role difficulties (VSRD), dependency (VSD), driving (D), colour vision (CV) and peripheral vision (PV). The subscales score ranges from 0 to 100. A score of 0 indicates the worst possible score and a score of 100 the best possible score. We have used the official VFQ-25 Greek translation by the Laboratory of Experimental Ophthalmology of Aristotle University, Thessaloniki, Greece, 2000 .
This study is in accordance with the Declaration of Helsinki and has been approved by the local Institutional Review Board. Written informed consent was obtained from all patients. The authors declare no conflict of interest.
The statistical analysis comprised the point-wise comparison between the two groups (TD vs. TD-K group) at the four time points (baseline, day 7, day 28 and day 42) for all sub-scales of the VFQ-25 questionnaire, as well as the composite score. Student’s t test was appropriately implemented when subscales were normally distributed (GH, GV, OP). On the other hand, in case of significant deviation from normality (NA, DA, VSSF, VSMH, VSRD, VSD, D, PV, as well as the composite score) Mann–Whitney–Wilcoxon test for independent samples (MWW for brevity) was performed. The deviation from normality was assessed by means of the Shapiro–Wilk test. Given that four comparisons took place for each outcome-subscale (baseline, day 7, day 28 and day 42), the Bonferroni correction for multiple comparisons was adopted; as a result, the threshold of statistical significance for p was set at 0.05/4 = 0.0125.
For the post hoc additional, secondary comparison aiming to examine whether the overall condition of patients improved after the completion of the follow-up period, Wilcoxon matched-pairs signed-rank test was performed on the VFQ-25 composite score, separately for each group. Statistical analysis was performed with STATA 11.1 statistical software (StataCorp, College Station, TX, USA).