Intraoperative Mitomycin C for glaucoma surgery

Mark Wilkins; Andrea Indar; Richard Wormald

doi:10.1002/14651858.CD002897.pub2

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Figure 1

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

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Figure 2

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

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Analysis 1.1

Comparison 1 Intraoperative Mitomycin C versus control, Outcome 1 Failure at 12 months.

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Analysis 1.2

Comparison 1 Intraoperative Mitomycin C versus control, Outcome 2 Mean intraocular pressure at 12 months.

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Analysis 1.3

Comparison 1 Intraoperative Mitomycin C versus control, Outcome 3 Complications ‐ wound leak.

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Analysis 1.4

Comparison 1 Intraoperative Mitomycin C versus control, Outcome 4 Complications ‐ hypotony.

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Analysis 1.5

Comparison 1 Intraoperative Mitomycin C versus control, Outcome 5 Complications ‐ late endophthalmitis.

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Analysis 1.6

Comparison 1 Intraoperative Mitomycin C versus control, Outcome 6 Complications ‐ expulsive haemorrhage.

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Analysis 1.7

Comparison 1 Intraoperative Mitomycin C versus control, Outcome 7 Complications ‐ shallow anterior chamber.

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Analysis 1.8

Comparison 1 Intraoperative Mitomycin C versus control, Outcome 8 Complications ‐ cataract.

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Intraoperative Mitomycin C compared with no antimetabolite or placebo for trabeculectomy surgery for glaucoma
Patient or population: People undergoing trabeculectomy surgery with glaucoma Settings: Eye clinics and hospitals Intervention: Intraoperative Mitomycin C applied in any dose for any duration Comparison: Placebo application or nothing
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	control	mitomycin C
Trabeculectomy failure at 12 months	Low risk population		RR 0.37 (0.26 to 0.51)	698 (11)	+++O moderate	medium risk population poorly designed studies may underestimate effect
	280 per 1000	77 per 1000 ([value] to [value])
	Medium risk population
	127 per 1000	135 per 1000 ([value] to [value])
	High risk population
	505 per 1000	156 per 1000 ([value] to [value])
mean intraocular pressure mmHg at 12 months	The mean IOP ranged across control groups from 15.9 to 23.9 mmHg	The mean IOP in the intervention groups was 11.1 to 14.6 mmHg	the WMD was ‐4.1 mmHg [‐4.68 to ‐3.34] mmHg	380 [8]	+++O moderate
complications wound leak by 12 months	Low risk population		RR 1.84 (0.72 to 4.66)	333 (7)	++OO low	no events reported in trials of high risk patients
	45 per 1000	114 per 1000 ([value] to [value])
	Medium risk population
	84 per 1000	112 per 1000 ([value] to [value])
	High risk population
	inestimable	inestimable
complications hypotony occurring up to 12 months	Low risk population		RR 1.8 (0.79 to 4.12)	488 (10)	++OO low	inconsistently defined and reported
	58 per 1000	61 per 1000 ([value] to [value])
	Medium risk population
	14 per 1000	37 per 1000 ([value] to [value])
	High risk population
	31 per 1000	83 per 1000 ([value] to [value])
complications shallow anterior chamber occurring within 12 months	Low risk population		RR 1.14 (0.42 to 3.07)	441 (10)	++OO low	inconsistently defined and reported
	169 per 1000	151 per 1000 ([value] to [value])
	Medium risk population
	0 per 1000	9 per 1000 ([value] to [value])
	High risk population
	145 per 1000	200 per 1000 ([value] to [value])
cataract formation by 12 months	Low risk population		RR 1.8 (1.00 to 3.22)	482 (7)	+++O moderate	outcome not relevant to medium risk population because these are combined cataract extraction and glaucoma procedures
	93 per 1000	190 per 1000 ([value] to [value])
	High risk population
	57 per 1000	80 per 1000 ([value] to [value])
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; RR: Risk Ratio; [other abbreviations, e.g.. OR, etc]
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: 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 quality: We are very uncertain about the estimate.

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Table 1. Mean baseline IOP and failure criteria

Trial	Mean baseline IOP	Failure criterion
Shin 1995	20.8 mmHg	< 20 mmHg plus > 20% fall in baseline IOP, without topical medication
Cohen 1996	21.3 mmHg	Eye requires additional glaucoma surgery
Costa 1996	25.6 mmHg	< 15 mmHg, without topical medication
Turacli 1996	31.9 mmHg	< 20 mmHg or > 25% fall in baseline IOP, without topical medication
Wu 1996	40.3 mmHg	< 21 mmHg , without topical medication
Andreanos 1997	32.4 mmHg	< 21 mmHg, without topical medication
Carlson 1997	18.8 mmHg	Not specified but results show all eyes were < 21 mmHg, topical medication was used
Martini 1997	28.2 mmHg	< 18 mmHg on or off topical medication
Robin 1997	29.7 mmHg	< 19 mmHg on or off topical medication
Szymanski 1997	Not specified	< 15 mmHg on topical medication
Shin 1998	17.6 mmHg	Eye requires glaucoma surgery, needling or topical medication

Table 1. Mean baseline IOP and failure criteria

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Comparison 1. Intraoperative Mitomycin C versus control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Failure at 12 months Show forest plot	11	698	Risk Ratio (M‐H, Fixed, 95% CI)	0.37 [0.26, 0.51]

1.1 High risk	4	193	Risk Ratio (M‐H, Fixed, 95% CI)	0.32 [0.20, 0.53]
1.2 Cataract extraction combined with trabeculectomy	3	167	Risk Ratio (M‐H, Fixed, 95% CI)	0.81 [0.37, 1.80]
1.3 Primary trabeculectomy	4	338	Risk Ratio (M‐H, Fixed, 95% CI)	0.29 [0.16, 0.53]
2 Mean intraocular pressure at 12 months Show forest plot	8	380	Mean Difference (IV, Fixed, 95% CI)	‐4.01 [‐4.68, ‐3.34]

2.1 High risk	3	144	Mean Difference (IV, Fixed, 95% CI)	‐5.31 [‐6.76, ‐3.85]
2.2 Cataract extraction combined with trabeculectomy	3	148	Mean Difference (IV, Fixed, 95% CI)	‐3.34 [‐4.16, ‐2.51]
2.3 Primary trabeculectomy	2	88	Mean Difference (IV, Fixed, 95% CI)	‐5.41 [‐7.34, ‐3.49]
3 Complications ‐ wound leak Show forest plot	7	333	Odds Ratio (M‐H, Fixed, 95% CI)	1.84 [0.72, 4.66]

3.1 High risk	2	98	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.2 Cataract extraction combined with trabeculectomy	3	178	Odds Ratio (M‐H, Fixed, 95% CI)	1.88 [0.68, 5.16]
3.3 Primary trabeculectomy	2	57	Odds Ratio (M‐H, Fixed, 95% CI)	1.65 [0.16, 17.47]
4 Complications ‐ hypotony Show forest plot	10	488	Odds Ratio (M‐H, Fixed, 95% CI)	1.80 [0.79, 4.12]

4.1 High risk	4	193	Odds Ratio (M‐H, Fixed, 95% CI)	2.83 [0.76, 10.48]
4.2 Cataract extraction combined with trabeculectomy	3	178	Odds Ratio (M‐H, Fixed, 95% CI)	1.65 [0.34, 7.94]
4.3 Primary trabeculectomy	3	117	Odds Ratio (M‐H, Fixed, 95% CI)	1.05 [0.23, 4.68]
5 Complications ‐ late endophthalmitis Show forest plot	2		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

5.1 Cataract extraction combined with trabeculectomy	2	107	Odds Ratio (M‐H, Fixed, 95% CI)	2.02 [0.20, 20.17]
6 Complications ‐ expulsive haemorrhage Show forest plot	10		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

6.1 High risk	3		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.2 Cataract extraction combined with trabeculectomy	3		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.3 Primary trabeculectomy	4		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
7 Complications ‐ shallow anterior chamber Show forest plot	10	441	Odds Ratio (M‐H, Fixed, 95% CI)	1.38 [0.73, 2.63]

7.1 High risk	3	144	Odds Ratio (M‐H, Fixed, 95% CI)	1.49 [0.62, 3.60]
7.2 Cataract extraction combined with trabeculectomy	3	178	Odds Ratio (M‐H, Fixed, 95% CI)	3.44 [0.13, 91.79]
7.3 Primary trabeculectomy	4	119	Odds Ratio (M‐H, Fixed, 95% CI)	1.14 [0.42, 3.07]
8 Complications ‐ cataract Show forest plot	7	482	Risk Ratio (M‐H, Fixed, 95% CI)	1.80 [1.00, 3.22]

8.1 High risk	3	144	Risk Ratio (M‐H, Fixed, 95% CI)	1.38 [0.45, 4.24]
8.2 Primary trabeculectomy	4	338	Risk Ratio (M‐H, Fixed, 95% CI)	1.93 [0.98, 3.80]

Comparison 1. Intraoperative Mitomycin C versus control

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