TABLE 2.
Continuous Analysis of Outcome Measures.
| Outcome Measure (Min to Max) | Arm | Baseline (BL) | Follow-Up (FU) | Absolute Change (FU-BL) | Rel. Change (FU-BL)/BL | ||||
| µ±SD (95% CI) | Median | µ±SD (95% CI) | Median | µ±SD (95% CI) | Median | FU vs. BL (P) | % | ||
| TBUT (sec) (0 to no limit) | IPL (N=60) | 3.0±1.4 (2.6–3.3) | 2.7 | 5.3±2.3 (4.7–5.9) | 5.1 | 2.3±1.9 (1.8 to 2.8) | 2.1 | d | 92 |
| Control (N=60) | 3.1±1.4 (2.8–3.5) | 2.8 | 3.6±1.9 (3.1–4.1) | 3.2 | 0.5±1.4 (0.1 to 0.8) | 0.4 | b | 22 | |
| IPLs vs. Control (P-value) | 0.53 | d | d | — | d | ||||
| SPEED (0–28) | IPL (N=60) | 15.2±4.7 (14–16.4) | 15 | 9.2±4.8 (7.9–10.4) | 8 | −6.1±5.1 (−7.4 to −4.8) | −6 | d | −38 |
| Control (N=60) | 14.1±4.9 (12.8–15.3) | 13.5 | 10.7±4.7 (9.5–11.9) | 10 | −3.4±4.7 (−4.6 to −2.2) | −3 | d | −22 | |
| IPLs vs. Control (P-value) | 0.19 | 0.08 | b | — | b | ||||
| MGYSS (imputed set) (0–45) | IPL (N=60) | 4.6±3.3 (3.7–5.4) | 4.3 | 10.8±6.8 (9.0–12.6) | 8.8 | 6.2±6.0 (4.7 to 7.8) | 5.5 | d | 193 |
| Control (N=60) | 5.3±3.3 (4.8–5.8) | 4.8 | 8.7±5.9 (8.1–9.3) | 8 | 3.4±4.8 (2.8 to 4.0) | 2.3 | d | 87 | |
| IPLs vs. Control (P-value) | 0.22 | 0.07 | b | — | a | ||||
| MGYSS (nonimputed set) (0–45) | IPL (N=59) | 4.6±3.4 (3.7–5.4) | 4.5 | 10.9±6.8 (9.2–12.7) | 9 | 6.3±6.0 (4.8 to 7.9) | 5.5 | d | 197 |
| Control (N=55) | 5.4±3.4 (4.5–6.3) | 5 | 9.1±6.0 (−4 to 26.5) | 8.5 | 3.7±4.9 (2.4 to 5.0) | 3 | d | 96 | |
| IPLs vs. Control (P-value) | 0.18 | 0.13 | a | — | 0.06 | ||||
| CFS (0–12) | IPL (N=60) | 1.5±1.7 (1.1–1.9) | 1 | 0.9±1.5 (0.5–1.2) | 0 | −0.6±1.0 (−0.9 to −0.4) | −0.5 | d | −51 |
| Control (N=60) | 1.8±2.0 (1.3–2.3) | 1.5 | 1.0±1.5 (0.6–1.4) | 0.5 | −0.8±1.7 (−1.3 to −0.4) | 0 | c | −44 | |
| IPLs vs. Control (P-value) | 0.34 | 0.58 | 0.49 | — | 0.61 | ||||
| CES (composite eyelid score) (0–5) | IPL (N=60) | 2.2±1.8 (1.8–2.7) | 2 | 2.0±1.9 (1.5–2.5) | 1.8 | −0.3±0.5 (−0.4 to −0.1) | 0 | c | −24 |
| Control (N=60) | 2.0±1.8 (1.5–2.5) | 1 | 1.9±1.9 (1.4–2.3) | 1 | −0.2±0.4 (−0.3 to −0.1) | 0 | c | −17 | |
| IPLs vs. Control (P-value) | 0.53 | 0.72 | 0.31 | — | 0.39 | ||||
| CCES (change of CES) (−5 to 5) | IPL (N=60) | — | — | 1.4 ±1.1 (1.1–1.7) | 1 | — | — | ||
| Control (N=60) | — | — | 0.9 ±1.1 (0.6–1.2) | 0.75 | — | — | |||
| IPLs vs. Control (P-value) | — | — | a | — | — | ||||
Except where noted, results describe the analysis performed on the imputed set, where missing values were completed with a Last Observation Carried Forward (LOCF) approach.
Statistical significance levels:
a
P or P<0.05.
b
P or P<0.01.
c
P or P<0.001.
d
P or P<0.0001.
CFS, corneal fluorescein staining score; CES, composite eyelid score; CCES, change in composite eyelid score; MGYSS, meibomian gland yielding secretion score; SPEED, standardized patient evaluation of eye dryness score; TBUT, tear breakup time.