Table 2.
Diagnostic tests | N | Day 1
|
Day 7
|
Day 30
|
Day 90
|
||||
---|---|---|---|---|---|---|---|---|---|
Mean ± SD | Significance | Mean ± SD | Significance | Mean ± SD | Significance | Mean ± SD | Significance | ||
OSDI | |||||||||
HA + trehalose | 7 | 11.21±18.8 | 0.11* | 7.14±3.9 | 0.03* | 3.27±2.6 | 0.035* | 2.68±2.88 | 0.16* |
HA | 6 | 31.72±24.1 | 16.76±9.2 | 11.46±8.6 | 5.9±4.83 | ||||
OSDI (difference with baseline) | |||||||||
HA + trehalose | 7 | 4.13±26.1 | 0.09** | 0.06±13.8 | 0.22** | −3.81±13.6 | 0.32** | −4.4±13.5 | 0.66** |
HA | 6 | 24.77±29.7 | 9.82±11.1 | 4.51±7.7 | −1.04±6.3 | ||||
SANDE frequency | |||||||||
HA + trehalose | 7 | 1.14±1.1 | 0.03* | 1.71±1.2 | 0.3* | 1.50±1.7 | 0.31* | 0.29±0.4 | 0.03* |
HA | 6 | 4.0±2.8 | 2.92±2.6 | 2.67±2.2 | 1.33±1.1 | ||||
SANDE frequency (difference with baseline) | |||||||||
HA + trehalose | 7 | 0.43±1.1 | 0.01** | 1.0±1.6 | 0.09** | 0.79±1.9 | 0.12** | −0.43±0.6 | 0.06** |
HA | 6 | 2.08±3.9 | 1.0±3.5 | 0.75±3 | −0.58±2.0 | ||||
SANDE severity | |||||||||
HA + trehalose | 7 | 0.57±0.8 | 0.01* | 0.79±0.7 | 0.01* | 0.50±0.5 | 0.02* | 0.36±0.5 | 0.01* |
HA | 6 | 3.50±2.1 | 2.08±0.9 | 1.92±1.3 | 1.17±0.5 | ||||
SANDE severity (difference with baseline) | |||||||||
HA + trehalose | 7 | 0.29±0.8 | 0.00** | 0.50±0.8 | 0.01** | 0.21±0.7 | 0.01** | 0.07±0.4 | 0.02** |
HA | 6 | 2.25±2.9 | 0.83±1.9 | 0.67±1.9 | −0.08±1.6 | ||||
Osmolarity | |||||||||
HA + trehalose | 14 | 311.6±17.6 | 0.54* | 306.07±11.3 | 0.48* | 308.86±16.7 | 0.73* | 306.21±9.6 | 0.65* |
HA | 12 | 308.17±9.3 | 302.90±9.9 | 306.92±10.3 | 304.58±8.2 | ||||
Osmolarity (difference with baseline) | |||||||||
HA + trehalose | 14 | 1.50±14.6 | 0.25** | −4.07±16.8 | 0.11** | −1.29±16.6 | 0.3** | −3.93±11.8 | 0.26** |
HA | 12 | 5.75±16.2 | 2.50±17.6 | 4.50±15.9 | 2.17±11.8 | ||||
VA | |||||||||
HA + trehalose | 14 | 0.02±0.04 | 1* | 0.03±0.04 | 0.85* | 0.01±0.05 | 0.16* | 0.0±0.0 | 0.28* |
HA | 12 | 0.02±0.04 | 0.03±0.05 | 0.03±0.04 | 0.01±0.03 | ||||
VA (difference with baseline) | |||||||||
HA + trehalose | 14 | 0.02±0.04 | 1** | 0.03±0.04 | 0.85** | 0.01±0.05 | 0.16** | 0.0±0.0 | 0.28** |
HA | 12 | 0.02±0.04 | 0.03±0.05 | 0.03±0.04 | 0.01±0.03 | ||||
van Bijsterveld scale | |||||||||
HA + trehalose | 14 | 2.43±2.0 | 0.34$ | 3.07±2.7 | 0.81$ | 1.79±1.9 | 0.06$ | 1.29±1.3 | 0.01$ |
HA | 12 | 3.08±1.7 | 3.17±1.8 | 3.00±1.6 | 3.0±1.8 | ||||
van Bijsterveld scale (difference with baseline) | |||||||||
HA + trehalose | 14 | 1.46±1.5 | 0.61$ | 2.08±2.6 | 0.8$ | 1.00±1.7 | 0.27$ | 0.46±1.1 | 0.12$ |
HA | 12 | 1.83±1.7 | 1.92±1.7 | 1.75±1.4 | 1.75±2.0 | ||||
Oxford scale | |||||||||
HA + trehalose | 14 | 0.86±0.8 | 0.05$ | 1.07±1 | 0.16$ | 0.75±0.7 | 0.02$ | 0.36±0.5 | 0.00$ |
HA | 12 | 1.42±0.5 | 1.58±0.7 | 1.42±0.5 | 1.50±0.7 | ||||
Oxford scale (difference with baseline) | |||||||||
HA + trehalose | 14 | 0.43±0.8 | 0.09$ | 0.64±1.1 | 0.27$ | 0.42±0.7 | 0.15$ | −0.07±0.6 | 0.00$ |
HA | 12 | 0.92±0.7 | 1.08±0.9 | 0.92±0.8 | 1.0±0.9 | ||||
NEI/Industry Workshop scale | |||||||||
HA + trehalose | 14 | 1.21±1.3 | 0.91$ | 2.07±2.8 | 1$ | 0.07±0.3 | 0.0$ | 0.21±0.4 | 0.07$ |
HA | 12 | 1.33±1.7 | 2.08±2.9 | 1.50±1.7 | 2.0±3.4 | ||||
NEI/Industry scale (difference with baseline) | |||||||||
HA + trehalose | 14 | 1.14±1.3 | 0.96$ | 2.0±2.8 | 1$ | 0.00±0.4 | 0.02$ | 0.14±0.5 | 0.12$ |
HA | 12 | 1.25±1.8 | 2.0±2.9 | 1.42±1.8 | 1.92±3.4 | ||||
TBUT | |||||||||
HA + trehalose | 14 | 6.29±5.3 | 0.36* | 6.18±6.3 | 0.73* | 9.0±7.6 | 0.25* | 6.86±5.7 | 0.9* |
HA | 12 | 4.79±1.8 | 6.92±4.0 | 6.21±3.2 | 6.58±4.8 | ||||
TBUT (difference with baseline) | |||||||||
HA + trehalose | 14 | −4.82±2.3 | 0.74** | −4.93±1.7 | 0.44** | −2.11±3.4 | 0.99** | −4.25±5.6 | 0.53** |
HA | 12 | −9.04±6.8 | −6.92±4.7 | −7.63±5.4 | −7.25±7.0 |
Notes:
Student’s t-test;
ANOVA paired test;
Mann–Whitney U-test.
Abbreviations: HA, hyaluronic acid; NEI, National Eye Institute; OSDI, Ocular Surface Disease Index; SANDE, Symptom Assessment in Dry Eye; SD, standard deviation; TBUT, tear breakup time; VA, visual acuity; ANOVA, analysis of variance.