| Literature DB >> 27920493 |
Yael Kusne1, Paul Kang1, Robert E Fintelmann2.
Abstract
PURPOSE: To compare the effect of topical prednisolone acetate 1% (PA) used after routine cataract surgery to the effect of difluprednate 0.05% (DFBA) used for the same indication on intraocular pressure (IOP).Entities:
Keywords: cataract surgery; glaucoma; intraocular pressure; steroid responder
Year: 2016 PMID: 27920493 PMCID: PMC5125796 DOI: 10.2147/OPTH.S121849
Source DB: PubMed Journal: Clin Ophthalmol ISSN: 1177-5467
Baseline demographic and clinical characteristics
| Variables | Overall population, N=3,488 | Difluprednate, n=1,337 | Prednisolone, n=2,151 | |
|---|---|---|---|---|
| Age in years, mean (SD) | 70.6 (8.6) | 70.6 (8.5) | 70.6 (8.7) | 0.85 |
| Male gender, n (%) | 1,384 (51.0) | 310 (53.1) | 1,074 (50.5) | 0.26 |
| Glaucoma history, n (%) | 548 (15.7) | 195 (14.6) | 353 (16.4) | 0.15 |
| Diabetes history, n (%) | 641 (18.4) | 253 (18.9) | 388 (18.0) | 0.51 |
| Intraocular pressure in mmHg, mean (SD) | 14.7 (3.2) | 14.6 (3.2) | 14.7 (3.2) | 0.46 |
Note:
P-value calculated using independent t-test for continuous variables and chi squared for continuous variables.
Abbreviation: SD, standard deviation.
IOP (in mmHg) changes in prednisolone versus difluprednate
| Overall population | Categories
| |||||
|---|---|---|---|---|---|---|
| Baseline | TP1 | Δ from baseline | TP2 | Δ from baseline | ≥21 mmHg overall and ≥10 mmHg increase at TP1 | |
| Prednisolone (n=2,151) | 14.7 (3.2) | 15.6 (4.3) | 0.89 (4.6) | 14.2 (3.2) | −0.49 (3.8) | 65 (3.02%) |
| Difluprednate (n=1,337) | 14.6 (3.2) | 16.2 (4.2) | 1.6 (4.7) | 14.6 (3.5) | 0.04 (4.2) | 59 (4.41%) |
| Δ mean IOP (95% CI) | −0.08 (−0.30, 0.13) | 0.60 (0.30, 0.90) | 0.21 (0.12, 0.31) | 0.46 (0.23, 0.68) | 0.16 (0.09, 0.23) | N/A |
| 0.46 | <0.001 | <0.001 | <0.001 | <0.001 | 0.04 | |
Notes: Data shown as mean (SD), mean change (SD), n (%), Δ mean (95% CI), or P-value.
P-values calculated using the analysis of covariance adjusted for baseline IOP.
P-values calculated using the Independent t-test.
P-values calculated using Fisher’s exact test at TP1.
P-value <0.001 comparing mean IOP change at each time point from baseline after multiple comparison adjustments.
Abbreviations: IOP, intraocular pressure; SD, standard deviation; TP1, 5–10 days postoperatively; TP2, 3–6 weeks postoperatively.
Figure 1General trends in IOP (mmHg) changes across study time points (TP1; TP2).
Notes: (A) Mean change (SE) in IOP from baseline among PA versus DFBA treatment arms. (B) Proportion (95% CI) of patients with IOP change ≥10 mmHg and overall IOP ≥21 mmHg at TP1 and TP2, respectively. *Analysis of covariance adjusted for baseline IOP to report P-values of <0.05 for the difference in mean change in IOP from baseline at each study time point. **Fisher’s exact test ≥ to report P-values of <0.05 for the difference in % of patients with IOP change ≥10 mmHg and overall IOP ≥21 mmHg in IOP from baseline at each study time point.
Abbreviations: CI, confidence interval; DFBA, difluprednate; IOP, intraocular pressure; PA, prednisolone acetate; SE, standard error; TP1, 5–10 days postoperatively; TP2, 3–6 weeks postoperatively.
IOP (mmHg) changes in patients stratified by risk factors: age, diabetes, and glaucoma
| Categories | Baseline | TP1 | Δ from baseline | TP2 | Δ from baseline | ≥21 mmHg, overall and ≥10 mmHg, increase at TP1 |
|---|---|---|---|---|---|---|
| >75 years old (n=1,001) | 14.7 (3.2) | 15.9 (4.5) | 1.2 (4.7) | 14.5 (3.4) | −0.20 (4.0) | 30 (3.0) |
| ≤75 years old (n=2,487) | 14.6 (3.2) | 15.4 (4.0) | 0.85 (4.5) | 14.1 (2.9) | −0.52 (3.6) | 94 (3.8) |
| Δ mean IOP (95% CI) | −0.09 (−0.32, 0.15) | 0.48 (−0.80, −0.16) | −0.45 (−0.75, −0.14) | −0.41 (−0.65, −0.16) | −0.38 (−0.62, −0.15) | N/A |
| 0.47 | 0.003 | 0.004 | 0.001 | 0.001 | 0.25 | |
| > | ||||||
| Prednisolone (n=617) | 14.7 (3.1) | 15.4 (4.1) | 0.68 (4.5) | 14.1 (3.0) | −0.57 (3.5) | 19 (3.1) |
| Difluprednate (n=384) | 14.5 (3.3) | 15.6 (3.8) | 1.1 (4.4) | 14.0 (2.8) | −0.44 (3.7) | 11 (2.9) |
| Δ mean IOP | −0.19 (−0.60, 0.21) | 0.22 (−0.29, 0.73) | 0.09 (−0.08, 0.26) | −0.05 (−0.42, 0.32) | 0.001 (−0.12, 0.12) | N/A |
| 0.36 | 0.40 | 0.28 | 0.78 | 0.991 | 0.84 | |
| Diabetes (n=641) | 15.0 (3.2) | 15.9 (4.3) | 1.2 (4.6) | 14.4 (3.1) | −0.22 (3.9) | 100 (3.5) |
| Non-diabetes (n=2,847) | 14.6 (3.2) | 15.8 (4.4) | 0.91 (4.7) | 14.4 (3.4) | −0.62 (3.9) | 24 (3.7) |
| Δ mean IOP (95% CI) | 0.47 (0.19, 0.74) | 0.20 (−0.16, 0.58) | 0.03 (−0.33, 0.39) | 0.07 (−0.21, 0.35) | −0.06 (−0.33, 0.21) | N/A |
| <0.001 | 0.28 | 0.87 | 0.60 | 0.67 | 0.78 | |
| Prednisolone (n=388) | 15.1 (3.3) | 15.9 (4.6) | 0.76 (4.9) | 14.4 (3.2) | −0.74 (4.03) | 15 (3.9) |
| Difluprednate (n=356) | 14.9 (3.1) | 16.1 (3.9) | 1.1 (4.3) | 14.6 (3.1) | −0.42 (3.9) | 9 (3.6) |
| Δ mean IOP | −0.13 (−0.64, 0.39) | 0.25 (−0.43, 0.93) | 0.10 (−0.12, 0.32) | 0.20 (0.29, 0.70) | 0.08 (−0.09, 0.23) | N/A |
| 0.63 | 0.47 | 0.87 | 0.43 | 0.36 | 0.84 | |
| Glaucoma (n=548) | 15.6 (3.6) | 17.5 (5.4) | 1.9 (5.6) | 15.2 (3.8) | −0.40 (4.4) | 41 (7.5) |
| Non-glaucoma (n=2,940) | 14.5 (3.1) | 15.5 (4.1) | 1.0 (4.4) | 14.2 (3.2) | −0.27 (3.8) | 83 (2.8) |
| Δ mean IOP (95% CI) | 1.1 (0.81, 1.4) | 2.0 (1.6, 2.4) | 1.6 (1.2, 2.0) | 0.97 (0.67, 1.3) | 0.67 (0.38, 0.96) | N/A |
| <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | |
| Prednisolone (n=353) | 15.8 (3.6) | 17.4 (5.2) | 1.6 (5.4) | 15.2 (3.8) | −0.54 (4.1) | 23 (5.6) |
| Difluprednate (n=195) | 15.3 (3.7) | 17.6 (5.7) | 2.4 (5.9) | 15.1 (3.9) | −0.15 (4.3) | 18 (9.2) |
| Δ mean IOP | −0.52 (−1.1, 0.12) | 0.23 (−0.71, 1.2) | 0.15 (−0.15, 0.46) | −0.13 (−0.80, 0.54) | 0.02 (−0.18, 0.23) | N/A |
| 0.11 | 0.62 | 0.33 | 0.70 | 0.82 | 0.25 |
Notes: Data shown as mean (SD), mean change (SD), n (%), Δ mean (95% CI), or P-value.
P-values calculated using the analysis of covariance adjusted for baseline IOP.
P-values calculated using the Independent t-test.
P-values calculated using Fisher’s exact test.
Denotes P-value <0.05 comparing mean IOP change at each time point from baseline after multiple comparison adjustments.
Denotes P-value <0.001 comparing mean IOP change at each time point from baseline after multiple comparison adjustments.
Abbreviations: IOP, intraocular pressure; TP1, 5–10 days postoperatively; TP2, 3–6 weeks postoperatively.
Figure 2Mean change (SE) in IOP (mmHg) from baseline in the total patient population.
Notes: Data stratified by (A) age categories, (B) diabetes status, and (C) glaucoma status. *Analysis of covariance adjusting for baseline IOP to report P-values of <0.05 for the difference in mean change in IOP from baseline at each study time point.
Abbreviations: IOP, intraocular pressure; SE, standard error; TP1, 5–10 days postoperatively; TP2, 3–6 weeks postoperatively.