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Study flow diagram.
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Figure 1

Study flow diagram.

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Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Forest plot of comparison: 1 NSAIDs versus corticosteroids, outcome: 1.1 Mean cell values at one week.
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Figure 4

Forest plot of comparison: 1 NSAIDs versus corticosteroids, outcome: 1.1 Mean cell values at one week.

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Forest plot of comparison: 1 NSAIDs versus corticosteroids, outcome: 1.2 Mean flare values at one week.
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Figure 5

Forest plot of comparison: 1 NSAIDs versus corticosteroids, outcome: 1.2 Mean flare values at one week.

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Forest plot of comparison: 2 NSAIDs plus corticosteroids versus corticosteroids alone, outcome: 2.1 Proportion of participants with cystoid macular edema at one week.
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Figure 6

Forest plot of comparison: 2 NSAIDs plus corticosteroids versus corticosteroids alone, outcome: 2.1 Proportion of participants with cystoid macular edema at one week.

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Comparison 1 NSAIDs versus corticosteroids, Outcome 1 Mean cell values at one week.
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Analysis 1.1

Comparison 1 NSAIDs versus corticosteroids, Outcome 1 Mean cell values at one week.

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Comparison 1 NSAIDs versus corticosteroids, Outcome 2 Mean flare values at one week.
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Analysis 1.2

Comparison 1 NSAIDs versus corticosteroids, Outcome 2 Mean flare values at one week.

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Comparison 1 NSAIDs versus corticosteroids, Outcome 3 Proportion of participants with cystoid macular edema one month postoperative.
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Analysis 1.3

Comparison 1 NSAIDs versus corticosteroids, Outcome 3 Proportion of participants with cystoid macular edema one month postoperative.

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Comparison 2 NSAIDs plus corticosteroids versus corticosteroids alone, Outcome 1 Proportion of participants with cystoid macular edema at one week.
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Analysis 2.1

Comparison 2 NSAIDs plus corticosteroids versus corticosteroids alone, Outcome 1 Proportion of participants with cystoid macular edema at one week.

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Comparison 2 NSAIDs plus corticosteroids versus corticosteroids alone, Outcome 2 Proportion of participants with cystoid macular edema at one month.
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Analysis 2.2

Comparison 2 NSAIDs plus corticosteroids versus corticosteroids alone, Outcome 2 Proportion of participants with cystoid macular edema at one month.

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Summary of findings for the main comparison. Summary of findings for NSAIDs versus corticosteroids

NSAIDs compared with corticosteroids for controlling inflammation after uncomplicated cataract surgery

Patient or population: people who received phacoemulsification

Intervention: NSAID

Comparison: corticosteroid

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Corticosteroid

NSAID

Intraocular inflammation measured by anterior chamber cell and flare

1 week

Cell values

—

174

(3 RCTs)

⊕⊕⊕⊝1
moderate

The cell values presented were measured using a Kowa cell meter. 2 additional studies measured cells using a slit lamp, but we were unable to combine these data as the studies used different scales to report the number of cells.

The mean cell value ranged from 3.7 to 5.8.

The mean cell value was0.24 cells lower (1.65 lower to 1.16 higher).

Flare values

—

365

(5 RCTs)

⊕⊕⊝⊝1,2
low

The flare values presented were measured using a Kowa cell meter. There was high statistical heterogeneity among the included studies (I2 = 92%).

The mean flare ranged from 15.65 to 48.3 photons/ms.

The mean flare was 13.74 photons/ms lower (21.47 lower to 6 lower).

Intraocular inflammation measured by proportion of participants with corneal edema

1 week

133 per 1000

103 per 1000

(35 to 305)

RR 0.77 (0.26 to 2.29)

114

(1 RCT)

⊕⊕⊝⊝3,4
low

Proportion of participants with best‐corrected visual acuity of 20/40

1 week

None of the included studies reported on this outcome.

Proportion of participants with cystoid macular edema

1 week

521 per 1000

135 per 1000

(89 to 214)

RR 0.26 (0.17 to 0.41)

291
(4 RCTs)

⊕⊕⊝⊝1,5
low

None of the included studies reported the proportion of participants with cystoid macular edema at 1 week, our intended outcome of interest. The data shown here are for 4 studies that reported on the presence of macular edema at 1 month.

Time to cessation of treatment

None of the included studies reported on this outcome.

Adverse events

None of the included studies reported on this outcome.

Economic outcomes

None of the included studies reported on this outcome.

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; RCT: randomized controlled trial; RR: risk ratio

GRADE Working Group grades of evidence
High‐certainty: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate‐certainty: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low‐certainty: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low‐certainty: We are very uncertain about the estimate.

1We downgraded the evidence due to risk of bias: the studies included in this meta‐analysis were poorly reported.
2We downgraded the certainty of the evidence due to inconsistency: the I2 for this estimate was 92%.
3We downgraded the certainty of the evidence because the study was unmasked: participants and outcome assessor were not masked, and there was high risk of performance and detection bias.
4We downgraded the certainty of the evidence due to imprecision.
5We downgraded the certainty of the evidence due to indirectness: the time point at which the study data were reported was one month rather than one week, and two of the studies, which made up 30% of the weight, used a weak corticosteroid in their comparison.

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Summary of findings for the main comparison. Summary of findings for NSAIDs versus corticosteroids
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Summary of findings 2. Summary of findings for NSAIDs plus corticosteroids versus corticosteroids alone

NSAIDs plus corticosteroids compared with corticosteroids alone for controlling inflammation after uncomplicated cataract surgery

Patient or population: people who received phacoemulsification

Intervention: NSAID plus corticosteroid

Comparison: corticosteroid alone

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Corticosteroid alone

NSAID plus corticosteroid

Intraocular inflammation measured by anterior chamber cell and flare

1 week

None of the included studies reported on this outcome.

Intraocular inflammation measured by proportion of participants with corneal edema

1 week

912 per 1000

976 per 1000

(894 to 1000)

RR 1.07 (0.98 to 1.16)

138
(1 RCT)

⊕⊕⊕⊝1
moderate

Proportion of participants with best‐corrected visual acuity of 20/40

1 week

None of the included studies reported on this outcome.

Proportion of participants with cystoid macular edema

1 week

47 per 1000

8 per 1000
(1 to 46)

RR 0.17 (0.03 to 0.97)

220
(2 RCTs)

⊕⊕⊝⊝2,3
low

7 additional studies (including 1213 participants) reported on the presence of cystoid macular edema at 1 month postoperatively. The meta‐analysis showed that the group that received a combination of NSAID plus corticosteroid had a lower risk of macular edema at 1 month compared with the group that received a corticosteroid only, however there was uncertainty in the measurement (RR 0.50, 95% CI 0.23 to 1.06)

Time to cessation of treatment

None of the included studies reported on this outcome.

Adverse events

See comment

—

—

—

Only 2 studies reported on adverse events. 1 reported that there were no adverse events related to NSAID use, but that 1 participant randomized to NSAIDs plus corticosteroid had heterogeneous retinal detachment as a complication of cataract surgery. Another study used the COMTOL questionnaire to ask participants about the frequency and severity of side effects; 3 of the top 5 most commonly reported side effects were markers of ocular discomfort: burning, redness, and blurred vision. The adverse events reported in this study were not separated by intervention group.

Economic outcomes

None of the included studies reported on this outcome.

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; COMTOL: Comparison of Ophthalmic Medications for Tolerability; RCT: randomized controlled trial; RR: risk ratio

GRADE Working Group grades of evidence
High‐certainty: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate‐certainty: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low‐certainty: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low‐certainty: We are very uncertain about the estimate.

1We downgraded the certainty of the evidence due to high risk of reporting bias: the study reported collecting data for certain time points, but results were not reported.
2We downgraded the certainty of the evidence due to inconsistency based on the heterogeneity of types, doses, and regimens of NSAIDs and corticosteroids used.
3We downgraded the certainty of the evidence due to imprecision: there was a small number of events for this outcome.

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Summary of findings 2. Summary of findings for NSAIDs plus corticosteroids versus corticosteroids alone
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Table 1. The SUN Working Group Grading Scheme for Anterior Chamber Cells

Cells/Grade

Cells per field

0

Less than 1

0.5+

1 to 5 cells

1+

6 to 15 cells

2+

16 to 25 cells

3+

26 to 50 cells

4+

More than 50 cells
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Table 1. The SUN Working Group Grading Scheme for Anterior Chamber Cells
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Table 2. The SUN Working Group Grading Scheme for Anterior Chamber Flare

Flare/Grade

Description

0

None to trace

1+

Faint

2+

Moderate (iris and lens details clear)

3+

Marked (iris and lens details hazy)

4+

Intense (fibrin or plastic aqueous)
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Table 2. The SUN Working Group Grading Scheme for Anterior Chamber Flare
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Table 3. Rating scale to determine the degree of ocular discomfort

Grade

Degree of ocular discomfort

Description

0

None

Absent

1

Mild

You experience ocular discomfort, but it does not interfere at all with your completion of daily tasks.

2

Moderate

You experience ocular discomfort and it slows you down, but you are able to carry out work of a light or sedentary nature (e.g. light house work, office work).

3

Severe

Your experience of ocular discomfort makes you completely unable to carry out any work activities.

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Table 3. Rating scale to determine the degree of ocular discomfort
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Table 4. Outcomes in included studies: Expected outcomes compared with reported outcomes

Primary Outcomes

Secondary outcomes

Study

Expected outcome: Proportion of participants with corneal edema >grade 0

Expected outcome: Proportion of participants with anterior chamber cells and flare >grade 1

Reported outcome: Cells and flare as a continuous measure

Expected outcome: Proportion of participants with BCVA of 20/40 or better

Reported outcome: Visual acuity as a continuous measure

Expected outcome: Proportion of participants with CME

Reported outcome: OCT outcomes or FFA outcomes measured continuously (macular thickness, total macular volume, macular cube volume, fluorescein leakage,etc)

Expected outcome: Time to cessation of treatment for inflammation

Expected outcome: Adverse events

Expected outcome: Economic outcomes (cost)

Studies comparing an NSAID to a corticosteroid

Asano 2008

Yes

Yes

Yes

Bucci 2001

Yes

Demco 1997

Yes

Yes

Yes

Duong 2014

Yes

Yes

Endo 2010

Data in figure only

Yes

Yes

Guzey 2000

Yes

Yes

Holzer 2002

Yes

Yes

Kato 1998

Partial

Laurell 2002

Yes

Yes

Miyake 2007

Yes

Yes

Yes

Yes

Miyake 2011

Yes

Yes

Yes

Yes

Roberts 1995

Yes

Solomon 2001

Yes

Yes

Voudouri 2002

Yes

Wang 2013

Yes

Yes

Studies comparing an NSAID plus a corticosteroid to a corticosteroid alone

Adam 2005

Almeida 2008

Cervantes‐Coste 2009

Yes

Chatziralli 2011

Data in figure only

Yes

Chen 2015

Yes

Dal 2014

Yes

Elsawy 2013

Yes

Yes

Entezari 2016

Yes

Yes

Yes

Li 2011

Yes

Yes

Yes

Mathys 2010

Yes

Yes

McColgin 1999

Yes

Yes

Moschos 2012

Yes

Yes

Yes

Ruiz Rodríguez 2011

Partial

Yes

Shimazaki 1996

Data in figure only

Yes

Singh 2012

Partial

Yes

Ticly 2014

Yes

Yes

Yes

Wittpenn 2008

Yes

Yes

Yes

Yes

Zaczek 2014

Data in figure only

Yes

Yes

Yes

Yes

Zhang 2008

Yes

Yes

Studies with other combinations of NSAIDs and corticosteroids

Almeida 2012

Yes

Donnenfeld 2006

Yes

Yes

Yes

Yes

el‐Harazi 1998

Yes

Hessemer 1996

Data in figure only

Yes

Yes

Jung 2015

Yes

Yes

Yes

Miyanaga 2009

Yes

Yes

Yes

Yes

Mulet 2001

Ostrov 1997

Yes

Yes

Yes

Sahu 2015

Yes

Yes

Yes

Schmitt 1995

Data in figure only

Trinavarat 2003

Yes

Yes

Yes

Yes

Tzelikis 2015

Yes

Yes

Yes

Yavas 2007

Yes

Yes

Zanetti 2012

Yes

Partial refers to studies missing data or not reporting all data needed to perform a meta‐analysis (such as reporting means without standard deviations) and studies reporting data at time points that were not of interest for this review.

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Table 4. Outcomes in included studies: Expected outcomes compared with reported outcomes
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Comparison 1. NSAIDs versus corticosteroids

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mean cell values at one week Show forest plot

3

Mean Difference (IV, Random, 95% CI)

Subtotals only

1.1 Measured with cell meter (cells per 0.075 mm3)

3

174

Mean Difference (IV, Random, 95% CI)

‐0.60 [‐2.19, 0.99]

2 Mean flare values at one week Show forest plot

5

Mean Difference (IV, Random, 95% CI)

Subtotals only

2.1 Measured with flare meter (photons/milisecond)

5

365

Mean Difference (IV, Random, 95% CI)

‐13.74 [‐21.45, ‐6.04]

3 Proportion of participants with cystoid macular edema one month postoperative Show forest plot

4

291

Risk Ratio (M‐H, Random, 95% CI)

0.26 [0.17, 0.41]
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Comparison 1. NSAIDs versus corticosteroids
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Comparison 2. NSAIDs plus corticosteroids versus corticosteroids alone

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Proportion of participants with cystoid macular edema at one week Show forest plot

2

220

Risk Ratio (M‐H, Fixed, 95% CI)

0.17 [0.03, 0.97]

2 Proportion of participants with cystoid macular edema at one month Show forest plot

7

1213

Risk Ratio (M‐H, Random, 95% CI)

0.50 [0.23, 1.06]
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Comparison 2. NSAIDs plus corticosteroids versus corticosteroids alone
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