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. 2019 Nov 2;9(11):e026752. doi: 10.1136/bmjopen-2018-026752

Table 4.

Summary of findings table

Summary of findings
Effectiveness and safety of difluprednate compared with prednisolone acetate after cataract surgery
Patient or population: patients who underwent cataract surgery
Intervention: difluprednate
Comparison: prednisolone acetate
Outcomes Anticipated absolute effects*(95% CI) Relative effect
(95% CI)
No of participants
(studies)
Certainty of the evidence
(GRADE)
Comments
Risk with prednisolone acetate Risk with effectiveness of difluprednate
Absence of AC cells or grade 0 at 15±2 days 641 per 1000 816 per 1000
(648 to 914)
OR 2.48
(1.03 to 5.93)
779
(5 RCTs)
⨁⨁◯◯
LOW*†
Absence of AC flare or grade 0 at 15±2 days 679 per 1000 884 per 1000
(703 to 961)
OR 3.60
(1.12 to 11.62)
379
(4 RCTs)
⨁⨁◯◯
LOW‡§
Absence of corneal oedema at 15±2 days 732 per 1000 799 per 1000
(636 to 901)
OR 1.46
(0.64 to 3.34)
604
(3 RCTs)
⨁⨁⨁◯
MODERATE¶
Absence of corneal oedema at 30±2 days 754 per 1000 794 per 1000
(600 to 909)
OR 1.26
(0.49 to 3.27)
504
(2 RCTs)
⨁⨁⨁◯
MODERATE**
High IOP (≥21 mm Hg or a change from baseline of ≥10 mm Hg) 9 per 1000 11 per 1000
(3 to 45)
OR 1.23
(0.29 to 5.18)
883
(6 RCTs)
⨁⨁⨁◯
MODERATE**

GRADE Working Group grades of evidence.

High certainty: we are very confident that the true effect lies close to that of the estimate of the effect.

Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.

Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.

Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

*One RCT has a high risk of bias, while three other RCTs have unclear risk of bias.

†Significant heterogeneity among studies (I2=75 %).

‡Two RCTs have unclear risk of bias.

§Significant heterogeneity among studies (I2=72%).

¶High risk of bias in one RCT and unclear risk in another one.

**High risk of bias in one RCT which has the largest weight.

AC, anterior chamber; GRADE, Grading of Recommendations Assessment, Development, and Evaluation; IOP, intraocular pressure; RCT, randomised-controlled trial.